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ele kt ro nis ch e V or ab -Fa ss un g* Deutscher Bundestag Drucksache 17/12213 17. Wahlperiode 30.01.2013 Antrag der Abgeordneten Dr. Edgar Franke, Christine Lambrecht, Bärbel Bas, Petra Ernstberger, Elke Ferner, Iris Gleicke, Angelika Graf, Ute Kumpf, Dr. Karl Lauterbach, Steffen-Claudio Lemme, Hilde Mattheis, Thomas Oppermann, Mechthild Rawert, Dr. Carola Reimann, Ewald Schurer, Marlies Volkmer, Dr. Frank-Walter Steinmeier und der Fraktion der SPD Bestechung und Bestechlichkeit im Gesundheitswesen unter Strafe stellen Der Bundestag wolle beschließen: I. Der Deutsche Bundestag stellt fest: Seit dem vergangenen Juni liegt der begründete Beschluss des Großen Strafsenats des Bundesgerichtshofes vom 29.3.2012 zur Frage der Strafbarkeit von niedergelassenen Vertragsärzten wegen Bestechlichkeit und Vorteilsannahme vor. Der Große Strafsenat hatte dort festgestellt, dass niedergelassene Vertragsärzte nach der gegenwärtigen Gesetzeslage strafrechtlich nicht verfolgt werden können. Im zugrundeliegenden Fall hatte eine Pharmareferentin Ärzten eine Beteiligung in Höhe von fünf Prozent des Medikamentenpreises zugesagt, wenn sie sich bereit erklärten, ihren Patienten künftig bevorzugt Präparate eines bestimmten Pharmaunternehmens zu verschreiben. Die Zahlungen wurden als Honorar für fiktive wissenschaftliche Vorträge ausgewiesen. Mit dem Beschluss des Großen Strafsenats besteht nun Rechtsklarheit darüber, dass korruptives Verhalten von niedergelassenen Vertragsärzten nach dem geltenden Strafrecht nicht strafbar ist und deshalb auch die Vertreter der Pharmaunternehmen bei Bestechungsvereinbarungen straffrei ausgehen. Der Bundesgerichtshof hält es zwar für berechtigt, der Korruption im Gesundheitswesen mit Mitteln des Strafrechts effektiv entgegenzutreten. Allerdings passt keine der bestehenden Strafvorschriften auf die besonderen Umstände im Gesundheitswesen. Also besteht eine Regelungslücke, die geschlossen werden muss. In seinem Beschluss hat der Bundesgerichtshof eine deutliche Aufforderung an den Gesetzgeber formuliert: „Vor dem Hintergrund der seit längerem im strafrechtlichen Schrifttum geführten Diskussion sowie im Hinblick auf gesetzgeberische Initiativen (vgl. dazu etwa Bundetagsdrucksache 17/3685) zur Bekämpfung korruptiven Verhaltens im Gesundheitswesen verkennt der Große Senat für Strafsachen nicht die grundsätzliche Berechtigung des Anliegens, Missständen, die – allem Anschein nach – gravierende finanzielle Belastungen des Gesundheitssystems zur Folge haben, mit Mitteln des Strafrechts effektiv entgegenzutreten.“ Die SPD-Bundestagsfraktion hat bereits in dem vom Bundesgerichtshof in Bezug genommenen Antrag vom 10.11.2012 „Korruption im Gesundheitswesen wirksam bekämpfen„ einen Straftatbestand für die Bestechung niedergelassener Vertragsärzte gefordert. Krankenkassen, Patientenvertretungen, Ermittlungsbehörden und Teile der Ärzteschaft hatten sich dieser Forderung angeschlossen. Die Bundesärztekammer vertrat dagegen bisher die Position, berufs- und standesrechtliche Regelungen seien ausreichend, Änderungen im Strafrecht seien nicht erforderlich. Diese Auffassung kann jedoch immer weniger überzeugen, weil nach derzeitiger Rechtslage bei angestellten Ärzten Bestechlichkeit strafrechtlich verfolgt werden kann, bei freiberuflich tätigen Ärzten jedoch nicht. Diese Ungleichbehandlung ist zunehmend schwerer zu erklären, da immer häufiger in Medizinischen Versorgungszentren angestellte und freiberufliche Ärzte Tür an Tür derselben Tätigkeit nachgehen. Während die einen wegen Bestechlichkeit verurteilt werden können, * Wird nach Vorliegen der lektorierten Druckfassung durch diese ersetzt. ele kt ro nis ch e V or ab -Fa ss un g 2 wenn sie Geld von einem Pharmaunternehmen für die Verordnung bestimmter Arzneimittel annehmen, bleiben die anderen straffrei. Mittlerweile hat sich überdies gezeigt, dass berufsrechtliche Sanktionen nur dann erfolgen, wenn Ermittlungen der Staatsanwaltschaften auch zu Anklagen und Verurteilungen führen. Da in Folge des BGH Beschlusses in vielen Fällen die Ermittlungen wegen der fehlenden Strafbarkeit eingestellt worden sind, unterbleiben in diesen Fällen in der Regel auch berufsrechtliche Sanktionen. Dieses Dilemma hat auch die Bundesärztekammer erkannt und ist von der bisher vertretenen Position, dass es keinen Handlungsbedarf gebe, abgewichen. Nunmehr fordert der Präsident der Bundesärztekammer eigene polizeiähnliche Ermittlungsbefugnisse, ist damit jedoch auf breite Kritik gestoßen. Auch einen generellen Straftatbestand, der Bestechlichkeit bei Freiberuflern unter Strafe stellt, befürwortet die Bundesärztekammer inzwischen. Patientinnen und Patienten müssen sich jederzeit darauf verlassen können, dass die unter Umständen lebenswichtigen Entscheidungen über ihre Diagnostik und Therapie ausschließlich aus medizinischen Gründen getroffen werden. Alleine der Verdacht, Zuwendungen an den behandelnden Arzt könnten z.B. die Auswahl eines Krebsmedikamentes beeinflussen, untergräbt das Vertrauensverhältnis zwischen Arzt und Patient. Nicht die Bestrafung von korrupten Ärzten schadet dem Berufsstand und dem Arzt-Patienten-Verhältnis, sondern die fehlende Regelung und die andauernde Debatte darüber. Korruption im Gesundheitswesen schadet Patientinnen und Patienten, allen ehrlichen Leis- tungserbringern und dem Gesundheitssystem insgesamt. Sie ist nicht beschränkt auf den ärztlichen Berufsstand, sondern findet sich in allen Bereichen des Gesundheitswesens. Sie ist zwar kein Massenphänomen, aber auch keine zu vernachlässigende Bagatelle einzelner schwarzer Schafe. Appelle, Selbstkontrollen und berufs- und standesrechtliche Regelungen haben sich als unzureichend erwiesen. Es ist notwendig, in unserer rechtlichen Werteordnung klar zum Ausdruck zu bringen, dass Bestechung und Bestechlichkeit hinter dem Rücken von Patientinnen und Patienten und zu Lasten des Gesundheitssystems kein Kavaliersdelikt ist, sondern einen Straftatbestand darstellt. Patientinnen und Patienten haben ebenso wie alle Leistungserbringer im Gesundheitswesen einen Anspruch auf Rechtsklarheit, wie mit Korruption im Gesundheitswesen umgegangen wird. Hierzu brauchen wir kein Spezialgesetz gegen Ärzte, wohl aber eine spezielle Regelung, die für alle Leistungserbringer im Gesundheitswesen gilt. Der Gesetzgeber muss handeln, um im Wettbewerb die vielen ehrlichen Ärzte und auch die übrigen Leistungserbringer vor den wenigen Korrupten zu schützen. Er muss außerdem handeln, um Patientinnen und Patienten die Sicherheit und das Vertrauen zurückzugeben, dass für ihre Behandlung nur medizinische Gründe ausschlaggebend sein dürfen und nicht etwaige Zuwendungen an ihre Behandler. II. Der Deutsche Bundestag fordert die Bundesregierung deshalb auf, endlich einen Gesetzentwurf vorzulegen, mit dem Korruption im Gesundheitswesen generell unter Strafe gestellt wird. Berlin, 30. Januar 2013 Dr. Frank-Walter Steinmeier und Fraktion

Deutscher Bundestag Drucksache 17/3685 17. Wahlperiode 10. 11. 2010 Antrag der Abgeordneten Dr. Edgar Franke, Christine Lambrecht, Bärbel Bas, Petra Ernstberger, Elke Ferner, Iris Gleicke, Angelika Graf (Rosenheim), Ute Kumpf, Dr. Karl Lauterbach, Steffen-Claudio Lemme, Hilde Mattheis, Thomas Oppermann, Mechthild Rawert, Dr. Carola Reimann, Ewald Schurer, Dr. Marlies Volkmer, Dr. Frank-Walter Steinmeier und der Fraktion der SPD Korruption im Gesundheitswesen wirksam bekämpfen Der Bundestag wolle beschließen: I. Der Deutsche Bundestag stellt fest: Durch Korruption, Abrechnungsbetrug und Falschabrechnung gehen der ge- setzlichen Krankenversicherung jedes Jahr erhebliche Summen an Versicher- tengeldern verloren. Experten des European Healthcare Fraud and Corruption Network schätzen, dass die Verluste zwischen 3 und 10 Prozent der Gesund- heitsausgaben betragen. Das wären in Deutschland alleine bei den gesetzlichen Krankenkassen zwischen 5 und 18 Mrd. Euro pro Jahr. Neben dem finanziellen Schaden drohen den Patientinnen und Patienten jedoch vor allem zum Teil lebensgefährliche Nachteile bei der Behandlung, wenn z. B. für die Auswahl einer Krebstherapie nicht die medizinischen Erfordernisse den Ausschlag geben, sondern mögliche Schmiergeldzahlungen an den behandeln- den Arzt. Immer wieder wurden in der Vergangenheit Korruptionsskandale im Gesund- heitswesen aufgedeckt. Fangprämien an niedergelassene Ärzte als Gegenleis- tung für Krankenhauseinweisungen, Falschabrechnungen in Krankenhäusern mit einem Milliardenschaden für die Krankenkassen, Schmiergeldzahlungen von Apothekern an Ärzte oder der sogenannte Herzklappenskandal sind nur einige Beispiele. Die Fraktion der SPD hat bereits in der letzten Wahlperiode einen Vorstoß un- ternommen, um der Korruption im Gesundheitswesen entgegenzutreten. Die Fraktion der CDU/CSU hat sich dem jedoch mit nicht nachvollziehbaren Be- gründungen widersetzt. Angesichts der nun anstehenden Beitragssatzsteigerun- gen und der in Zukunft drohenden Kopfpauschalen muss aus Sicht der Fraktion der SPD jede Art der Verschwendung von Beitragsmitteln konsequent be- kämpft werden. II. Der Deutsche Bundestag fordert die Bundesregierung auf, 1. durch ergänzende Regelungen im Strafgesetzbuch sicherzustellen, dass Korrup- tionshandlungen niedergelassener Vertragsärzte Straftatbestände darstellen; 2. durch entsprechende gesetzliche Regelungen sicherzustellen, dass syste- matische Falschabrechnungen von Krankenhäusern mit spürbaren Sanktio- nen geahndet werden; Drucksache 17/3685 – 2 – Deutscher Bundestag – 17. Wahlperiode 3. auf die Länder einzuwirken, damit diese besonders qualifizierte Schwer- punktstaatsanwaltschaften und Ermittlungsgruppen bei der Kriminalpolizei zur Verfolgung von Korruption im Gesundheitswesen errichten. Begleitend sollten Angebote zur Fortbildung von Richtern und Staatsanwälten mit einem möglichst einheitlichen Curriculum realisiert werden; 4. einen besonderen, auf sozialversicherungsrechtliche Sachverhalte abzielen- den Straftatbestand zu schaffen, der neben dem Vermögen die besondere Stellung der gesetzlichen Krankenversicherung und der Patientinnen und Patienten schützt; 5. die Stellen zur Bekämpfung von Fehlverhalten als Profit-Center innerhalb der sie tragenden Organisationen zu verankern, damit der erwünschte perso- nelle Ausbau nicht durch die von der Koalition geplante Deckelung der Ver- waltungskosten der Krankenkassen verhindert wird. Berlin, 10. November 2010 Dr. Frank-Walter Steinmeier und Fraktion Begründung 1. Derzeit ist in der staatsanwaltschaftlichen Praxis und in der juristischen Lite- ratur höchst umstritten, ob sich niedergelassene Vertragsärzte wegen Kor- ruptionshandlungen strafbar machen können. In der Praxis werden Fälle berichtet, in denen krebskranke Patienten mit extrem teuren Arzneimitteln behandelt werden, von deren Einsatz der behandelnde Arzt finanziell profi- tiert. Ob die Behandlung auch dem Patienten nutzt, ist dann nachrangig. Selbst in einem so drastischen Fall ist es bisher nicht sicher, dass der Arzt wegen Bestechlichkeit belangt werden kann. Die Fraktion der SPD fordert, dass es einen strafrechtlichen Schutz für die Patienten geben muss, der si- cherstellt, dass nicht wirtschaftliche, sondern ausschließlich medizinische Beweggründe für die Art der Behandlung maßgeblich sind. Besonders ab- wegig ist die bisherige Rechtslage, weil § 299 des Strafgesetzbuchs (StGB) (Bestechlichkeit und Bestechung im geschäftlichen Verkehr) derzeit zwar auf angestellte Ärzte, z. B. in Krankenhäusern angewandt wird, nicht jedoch auf freiberuflich Tätige. Diskutiert werden hier sowohl die Anwendung der Amtsdelikte nach § 331 ff. StGB als auch von § 299 StGB. Zwischenzeitlich ist die Minder- meinung, die für eine Anwendung der vorhandenen Korruptionsdelikte auf niedergelassene Vertragsärzte plädiert, auch in der Praxis zwar langsam im Vormarsch (beispielsweise Generalstaatsanwaltschaften Koblenz und Braun- schweig). Ob sich diese aber – auch bei den Strafgerichten – durchsetzt, kann zurzeit noch nicht abgeschätzt werden. Es würde in jedem Fall einen länge- ren Zeitraum in Anspruch nehmen. Nicht zuletzt um ein politisches Signal zu setzen und um für Rechtssicherheit zu sorgen, ist eine Klarstellung durch den Gesetzgeber geboten. 2. Die Krankenkassen sind zur Prüfung von Krankenhausrechnungen ver- pflichtet. Verändert sich der Abrechnungsbetrag infolge der Prüfung nicht, muss die Krankenkasse dem Krankenhaus 300 Euro pro Fall zahlen. Wenn das Krankenhaus jedoch einen Fehler gemacht hat und die Abrechnung falsch war, muss es lediglich das falsch abgerechnete Geld an die Kranken- kassen zurückzahlen. Diese ungleiche Regelung schafft Anreize zur syste- Deutscher Bundestag – 17. Wahlperiode – 3 – Drucksache 17/3685 matischen Falschabrechnung, auch wenn dies den Krankenhäusern keines- wegs grundsätzlich unterstellt wird. Neben der entsprechenden Vorschrift nach § 275 Absatz 1c des Fünften Bu- ches Sozialgesetzbuch, wonach die Krankenkassen den Krankenhäusern eine Aufwandspauschale in Höhe von 300 Euro bei nicht erfolgreichen Prü- fungen durch den Medizinischen Dienst der Krankenversicherung zahlen müssen, fehlt eine entsprechende Vorschrift, die Falschabrechnungen der Krankenhäuser sanktioniert. Sonstige negative Folgen, z. B. in Form eines Bußgeldes, sind mit der fehlerhaften Abrechnung nicht verbunden. Um An- reize zur Falschabrechnung zu vermeiden, müssen neben der Rückzahlung der falschen Abrechnungen auch spürbare Sanktionen für systematische Falschabrechungen erfolgen. 3. Die Einrichtung von Schwerpunktstaatsanwaltschaften bzw. Verwaltungs- einheiten mit sozialrechtlichem Spezialwissen muss forciert werden. Da diese Maßnahme im Verantwortungsbereich der Länder liegt, besteht keine direkte Gesetzgebungskompetenz durch den Bundesgesetzgeber. Es muss hier jedoch zumindest ein dringender Appell der Bundesregierung an die Länder erfolgen. Es bestehen nach den Erfahrungen der Fehlverhaltensbekämpfungsstellen der Krankenkassen bei den Ermittlungsbehörden (Staatsanwaltschaften, Kri- minalpolizei), aber auch bei den Strafgerichten zumindest der ersten Instanz deutliche Defizite hinsichtlich der Kenntnis zwingend zu berücksichtigender sozialrechtlicher Besonderheiten. Das erforderliche Spezialwissen ist bisher nur bei den wenigen bereits eingerichteten Schwerpunktstaatsanwaltschaf- ten bzw. speziellen Verwaltungseinheiten, z. B. in Bayern, Saarland, Rhein- land-Pfalz, Hessen, Niedersachsen vorhanden. Es ist daher mindestens ge- boten, die Mitarbeiter von Staatsanwaltschaften und Kriminalpolizei in dem für die jeweilige Region angemessenen Umfang hinsichtlich der ständigen Rechtsprechung des Bundeszozialgerichts und des Bundesgerichtshofs in Strafsachen ausreichend zu schulen. 4. Wenn – wie gerade in den Berliner DRK-Kliniken geschehen – Ärzte eines Krankenhauses Operationen durchführen, ohne die notwendigen Qualifika- tionen zu besitzen und dafür eine Rechnung gestellt wird, als ob die OP vom dafür qualifizierten Arzt erbracht worden wäre, dann ist der Kasse nach der- zeitiger Rechtslage kein Schaden entstanden, weil die Leistung auch bei ord- nungsgemäßer Erbringung hätte bezahlt werden müssen. Das gesundheit- liche Risiko für den Patienten und die generelle Frage der Behandlungs- qualität spielt für die strafrechtliche Qualifizierung als Betrug keine Rolle. Zurzeit gibt es für Fälle des Abrechnungsbetruges keinen Sondertatbestand, so dass der „normale“ Betrugsstraftatbestand des § 263 StGB herangezogen wird. Dieser schützt als reines Vermögensdelikt – von wenigen zudem strit- tigen Ausnahmen abgesehen – nur tatsächliche, objektiv messbare Eingriffe in das Vermögen. Für den optimalen Schutz sozialversicherungstypischer Rechtsgüter ist daher die Schaffung eines speziellen Straftatbestandes drin- gend erforderlich. 5. Wenn sich eine Krankenkasse bisher bei der Bekämpfung des Abrechnungs- betrugs stark engagiert hat und dazu zusätzliches Personal eingestellt hat, konnte sie zwar Rückforderungen aus unrechtmäßig erhaltenen Honoraren, Schadenersatz und Vertragsstrafen geltend machen. Sie hat allerdings gleichzeitig durch den verstärkten Personaleinsatz zur Aufdeckung des Fehl- verhaltens auch ihre Verwaltungskosten erhöht. Die von der Koalition im GKV-Finanzierungsgesetz geplante Verwaltungskostenbudgetierung der Krankenkassen wird u. U. dazu führen, dass Kassen ihre Ermittlungsabtei- lungen verkleinern oder ganz abbauen. Sie könnten damit zwar die gesetz- Drucksache 17/3685 – 4 – Deutscher Bundestag – 17. Wahlperiode lich verlangte Verwaltungskostendeckelung einhalten, gleichzeitig würden ihnen aber die viel höheren Erträge durch die Ermittler verloren gehen. Die Stellen zur Bekämpfung von Fehlverhalten müssen deshalb innerhalb der sie tragenden Organisationen als Profit-Center organisiert sein. Den Kosten der Stellen müssen ihre Erträge gegenübergestellt werden. Ein star- kes Engagement einer Krankenkasse mit entsprechend hohen Personalkos- ten darf nicht einseitig als Verwaltungskostensteigerung gebucht werden, während erlöste Schadenersatzzahlungen, Vertragsstrafen, o. Ä. bei den Leistungsausgaben gegengerechnet werden. Gesamtherstellung: H. Heenemann GmbH & Co., Buch- und Offsetdruckerei, Bessemerstraße 83–91, 12103 Berlin, www.heenemann-druck.de Vertrieb: Bundesanzeiger Verlagsgesellschaft mbH, Postfach 10 05 34, 50445 Köln, Telefon (02 21) 97 66 83 40, Fax (02 21) 97 66 83 44, www.betrifft-gesetze.de ISSN 0722-8333

Stellungnahme des Bundesverbandes der Arzneimittel-Hersteller e.V. (BAH) zu dem Antrag der SPD-Bundestagsfraktion „Korruption im Gesundheitswesen wirksam bekämpfen“ Drucksache 17/3685 vom 10.11.2010 Der BAH vertritt die Interessen der Arzneimittelindustrie gegenüber der Bundesregie- rung, dem Bundestag und dem Bundesrat. Mit seinen 435 Mitgliedsunternehmen, darunter 324 Arzneimittel-Hersteller, ist er der mitgliederstärkste Verband im Arznei- mittelbereich. Die politische Interessenvertretung und die Betreuung der Mitglieder erstreckt sich zum einen auf den Bereich der Selbstmedikation, zum anderen auf das Gebiet der rezeptpflichtigen Arzneimittel mit Ausnahme der patentgeschützten Prä- parate. Der BAH bedankt sich für die Möglichkeit, zu diesem Antrag Stellung zu nehmen und kommt der Bitte gerne nach. Vorbemerkung: Der Korruption im Allgemeinen und im Gesundheitswesen im Besonderen ist strikt entgegenzutreten. Voraussetzung für eine wirksame Korruptionsbekämpfung sind in erster Linie klare rechtliche Regelungen und Vorgaben für die handelnden Personen und ein entsprechendes Bewusstsein dafür, dass Entscheidungen im Zusammen- hang mit der Gesundheitsversorgung, bei Therapie-, Versorgungs- und Beschaf- fungsentscheidungen, unbeeinflusst erfolgen müssen. Auf der anderen Seite ist die Zusammenarbeit der im Gesundheitswesen handelnden Personen nicht per se zu verurteilen und unter Generalverdacht zu stellen. Koopera- tionen und eine Zusammenarbeit zwischen Industrie, medizinischen Einrichtungen, deren Mitarbeitern etc. ist insbesondere aus rechtlichen Gründen notwendig und auch forschungs- und gesundheitspolitisch erwünscht. Insbesondere die medizini- sche Forschung und die Weiterentwicklung von Arzneimitteln und Medizinprodukten erfordert zwingend eine enge Zusammenarbeit der Industrie mit medizinischen Ein- richtungen und Ärzten. Das Gleiche gilt für die Zusammenarbeit der Industrie mit nie- dergelassenen Ärzten, insbesondere im Hinblick auf die Vermittlung von Informatio- nen. Der BAH hat sich stets und wird sich auch in Zukunft weiterhin dafür einsetzen, dass die Zusammenarbeit in den rechtlichen Grenzen und damit korruptionsfrei er- folgt. Daher hat er sich bereits im Jahr 2000 dem Gemeinsamen Standpunkt zur strafrechtlichen Bewertung der Zusammenarbeit zwischen Industrie, medizinischen Einrichtungen und deren Mitarbeitern, zusammen mit der Arbeitsgemeinschaft der 2 wissenschaftlichen medizinischen Fachgesellschaften, der Bundesärztekammer, Bundesfachverband Medizinprodukteindustrie e.V., Bundesverband der pharmazeu- tischen Industrie e.V. (BPI), Deutscher Hochschulverband, Deutsche Krankenhaus- gesellschaft, Verband der Diagnostikaindustrie e.V. und dem Verband Forschender Arzneimittelhersteller e.V. (vfa) angeschlossen. Im Jahr 2003 hat dann der BAH, ge- meinsam mit BPI und dem vfa Verhaltensempfehlungen für die Zusammenarbeit der pharmazeutischen Industrie mit Ärzten beschlossen und veröffentlicht. Die Intention des Antrags der SPD-Bundestagsfraktion „Korruption im Gesundheits- wesen wirksam bekämpfen“ wird daher begrüßt. Er ist jedoch in Teilen überholt – er stammt bereits aus November 2010 – und ist in anderen Bereichen nicht zielführend. Dazu im Einzelnen: 1. Ergänzender Straftatbestand für Korruptionshandlungen niedergelassener Vertragsärzte: Die Frage, ob bzw. inwieweit niedergelassene Ärzte als Amtsträger oder als Beauf- tragte der gesetzlichen Krankenkassen anzusehen sind und sich daher der Bestech- lichkeit bzw. Vorteilsannahme – ggf. im geschäftlichen Verkehr – strafbar machen können, wird derzeit höchstrichterlich geklärt. Der Bundesgerichtshof (BGH) hat mit Beschluss vom 5. Mai 2011, Az.: 3 StR 458/10, diese Frage dem Großen Senat für Strafsachen zur Entscheidung vorgelegt. Es ist jederzeit mit einer Entscheidung zu rechnen. Aus Äußerungen, u.a. im Rahmen der Begründung des Beschlusses des BGH wird deutlich, dass eine Strafbarkeit in diesen Fällen angenommen wird. Es stellt sich hier lediglich die Frage, auf welchen Straftatbestand diese gestützt wird. Somit wird schneller als im Rahmen eines regulären Gesetzgebungsverfahrens Rechtssicherheit und Rechtsklarheit hergestellt werden. Der BAH schlägt daher vor, diese Entscheidung abzuwarten. 2. Ahndung systematischer Falschabrechnungen von Krankenhäusern: Hierzu kann sich der BAH mangels Betroffenheit nicht äußern. 3. Gründung qualifizierter Schwerpunkt-Staatsanwaltschaften und Ermitt- lungsgruppen bei der Kriminalpolizei: Dieser Vorschlag ist zu begrüßen. Es ist allerdings darauf hinzuweisen, dass es be- reits eine Reihe von Schwerpunkt-Staatsanwaltschaften in diesem Bereich gibt, so in Bayern, Hessen, Niedersachsen, Rheinland-Pfalz und dem Saarland. 4. Besonderer Straftatbestand zum Schutz der besonderen Stellung der ge- setzlichen Krankenversicherung und der Patientinnen und Patienten: Ein Straftatbestand, wie in diesem Punkt gefordert, wirft eine ganze Reihe von Fra- gen auf. Zunächst stellt sich die Frage, ob überhaupt eine Strafbarkeitslücke vorliegt. Nach Auffassung des BAH ist eine solche Lücke zu verneinen. Soweit in der Begrün- dung des Antrags beispielhaft darauf hingewiesen wird, dass Ärzte ohne die notwen- 3 dige Qualifikation Operationen durchgeführt haben und dafür honoriert worden sind, so ist auch hier keine Strafbarkeitslücke gegeben. In dem beschriebenen Fall hätte kein Honoraranspruch der Ärzte bestanden. Wenn dieser doch geltend gemacht wird, so liegt Betrug vor. Daneben kommen weitere Straftatbestände in Betracht. Mögli- cherweise sind die betroffenen Patienten über die mangelnde Qualifikation der Ärzte nicht aufgeklärt worden, so dass insofern eine nicht ordnungsgemäße Einwilligung für die Operation vorliegt, was eine mögliche Strafbarkeit der Körperverletzung zur Folge hätte. Rechtlich ist ein solch angedachter Straftatbestand, dessen Voraussetzungen nicht klar umrissen sind, auch kritisch zu bewerten. Es wird nicht deutlich, was unter „so- zialversicherungstypischen Rechtsgütern“ zu verstehen ist. Unklare Begrifflichkeiten verstoßen gegen das Rechtsstaatsprinzip. Im Übrigen ist es nicht sinnvoll, ein u.U. in einer unklaren Situation vorgenommenes Verhalten mit intransparenten und unüber- sichtlichen Regelungen noch zusätzlich zu pönalisieren. Vielmehr sollten die ent- sprechenden Regelungen deutlich gefasst werden. 5. Gründung von Profit-Centern: Die Gründung solcher Profitcentern ist kritisch zu betrachten. Grundsätzlich sind Stel- len zur Bekämpfung von Fehlverhalten innerhalb der maßgebenden Organisationen sinnvoll und zu befürworten. Allerdings ist die Ausgestaltung dieser Stellen als Profit- Center nicht mit dem Rechtsstaatsprinzip zu vereinbaren. Eine Ermittlung bzw. Über- prüfung von möglichen Fehlverhalten muss ergebnisoffen erfolgen und es darf nicht der Anreiz geschaffen werden, – zur Legitimierung einer solchen Stelle – möglichst viele Korruptionsfälle zu finden. Dies fördert vielmehr eine Atmosphäre des Misstrau- ens und eine Kriminalisierung von Kooperationen und Zusammenarbeit. Bonn, 21. März 2012 Schm/Rü

Stellungnahme des Bundesverbandes der Arzneimittel-Hersteller e.V. (BAH) zu dem Antrag der SPD-Bundestagsfraktion „Korruption im Gesundheitswesen wirksam bekämpfen“ Drucksache 17/3685 vom 10.11.2010 Der BAH vertritt die Interessen der Arzneimittelindustrie gegenüber der Bundesregie- rung, dem Bundestag und dem Bundesrat. Mit seinen 435 Mitgliedsunternehmen, darunter 324 Arzneimittel-Hersteller, ist er der mitgliederstärkste Verband im Arznei- mittelbereich. Die politische Interessenvertretung und die Betreuung der Mitglieder erstreckt sich zum einen auf den Bereich der Selbstmedikation, zum anderen auf das Gebiet der rezeptpflichtigen Arzneimittel mit Ausnahme der patentgeschützten Prä- parate. Der BAH bedankt sich für die Möglichkeit, zu diesem Antrag Stellung zu nehmen und kommt der Bitte gerne nach. Vorbemerkung: Der Korruption im Allgemeinen und im Gesundheitswesen im Besonderen ist strikt entgegenzutreten. Voraussetzung für eine wirksame Korruptionsbekämpfung sind in erster Linie klare rechtliche Regelungen und Vorgaben für die handelnden Personen und ein entsprechendes Bewusstsein dafür, dass Entscheidungen im Zusammen- hang mit der Gesundheitsversorgung, bei Therapie-, Versorgungs- und Beschaf- fungsentscheidungen, unbeeinflusst erfolgen müssen. Auf der anderen Seite ist die Zusammenarbeit der im Gesundheitswesen handelnden Personen nicht per se zu verurteilen und unter Generalverdacht zu stellen. Koopera- tionen und eine Zusammenarbeit zwischen Industrie, medizinischen Einrichtungen, deren Mitarbeitern etc. ist insbesondere aus rechtlichen Gründen notwendig und auch forschungs- und gesundheitspolitisch erwünscht. Insbesondere die medizini- sche Forschung und die Weiterentwicklung von Arzneimitteln und Medizinprodukten erfordert zwingend eine enge Zusammenarbeit der Industrie mit medizinischen Ein- richtungen und Ärzten. Das Gleiche gilt für die Zusammenarbeit der Industrie mit nie- dergelassenen Ärzten, insbesondere im Hinblick auf die Vermittlung von Informatio- nen. Der BAH hat sich stets und wird sich auch in Zukunft weiterhin dafür einsetzen, dass die Zusammenarbeit in den rechtlichen Grenzen und damit korruptionsfrei er- folgt. Daher hat er sich bereits im Jahr 2000 dem Gemeinsamen Standpunkt zur strafrechtlichen Bewertung der Zusammenarbeit zwischen Industrie, medizinischen Einrichtungen und deren Mitarbeitern, zusammen mit der Arbeitsgemeinschaft der 2 wissenschaftlichen medizinischen Fachgesellschaften, der Bundesärztekammer, Bundesfachverband Medizinprodukteindustrie e.V., Bundesverband der pharmazeu- tischen Industrie e.V. (BPI), Deutscher Hochschulverband, Deutsche Krankenhaus- gesellschaft, Verband der Diagnostikaindustrie e.V. und dem Verband Forschender Arzneimittelhersteller e.V. (vfa) angeschlossen. Im Jahr 2003 hat dann der BAH, ge- meinsam mit BPI und dem vfa Verhaltensempfehlungen für die Zusammenarbeit der pharmazeutischen Industrie mit Ärzten beschlossen und veröffentlicht. Die Intention des Antrags der SPD-Bundestagsfraktion „Korruption im Gesundheits- wesen wirksam bekämpfen“ wird daher begrüßt. Er ist jedoch in Teilen überholt – er stammt bereits aus November 2010 – und ist in anderen Bereichen nicht zielführend. Dazu im Einzelnen: 1. Ergänzender Straftatbestand für Korruptionshandlungen niedergelassener Vertragsärzte: Die Frage, ob bzw. inwieweit niedergelassene Ärzte als Amtsträger oder als Beauf- tragte der gesetzlichen Krankenkassen anzusehen sind und sich daher der Bestech- lichkeit bzw. Vorteilsannahme – ggf. im geschäftlichen Verkehr – strafbar machen können, wird derzeit höchstrichterlich geklärt. Der Bundesgerichtshof (BGH) hat mit Beschluss vom 5. Mai 2011, Az.: 3 StR 458/10, diese Frage dem Großen Senat für Strafsachen zur Entscheidung vorgelegt. Es ist jederzeit mit einer Entscheidung zu rechnen. Aus Äußerungen, u.a. im Rahmen der Begründung des Beschlusses des BGH wird deutlich, dass eine Strafbarkeit in diesen Fällen angenommen wird. Es stellt sich hier lediglich die Frage, auf welchen Straftatbestand diese gestützt wird. Somit wird schneller als im Rahmen eines regulären Gesetzgebungsverfahrens Rechtssicherheit und Rechtsklarheit hergestellt werden. Der BAH schlägt daher vor, diese Entscheidung abzuwarten. 2. Ahndung systematischer Falschabrechnungen von Krankenhäusern: Hierzu kann sich der BAH mangels Betroffenheit nicht äußern. 3. Gründung qualifizierter Schwerpunkt-Staatsanwaltschaften und Ermitt- lungsgruppen bei der Kriminalpolizei: Dieser Vorschlag ist zu begrüßen. Es ist allerdings darauf hinzuweisen, dass es be- reits eine Reihe von Schwerpunkt-Staatsanwaltschaften in diesem Bereich gibt, so in Bayern, Hessen, Niedersachsen, Rheinland-Pfalz und dem Saarland. 4. Besonderer Straftatbestand zum Schutz der besonderen Stellung der ge- setzlichen Krankenversicherung und der Patientinnen und Patienten: Ein Straftatbestand, wie in diesem Punkt gefordert, wirft eine ganze Reihe von Fra- gen auf. Zunächst stellt sich die Frage, ob überhaupt eine Strafbarkeitslücke vorliegt. Nach Auffassung des BAH ist eine solche Lücke zu verneinen. Soweit in der Begrün- dung des Antrags beispielhaft darauf hingewiesen wird, dass Ärzte ohne die notwen- 3 dige Qualifikation Operationen durchgeführt haben und dafür honoriert worden sind, so ist auch hier keine Strafbarkeitslücke gegeben. In dem beschriebenen Fall hätte kein Honoraranspruch der Ärzte bestanden. Wenn dieser doch geltend gemacht wird, so liegt Betrug vor. Daneben kommen weitere Straftatbestände in Betracht. Mögli- cherweise sind die betroffenen Patienten über die mangelnde Qualifikation der Ärzte nicht aufgeklärt worden, so dass insofern eine nicht ordnungsgemäße Einwilligung für die Operation vorliegt, was eine mögliche Strafbarkeit der Körperverletzung zur Folge hätte. Rechtlich ist ein solch angedachter Straftatbestand, dessen Voraussetzungen nicht klar umrissen sind, auch kritisch zu bewerten. Es wird nicht deutlich, was unter „so- zialversicherungstypischen Rechtsgütern“ zu verstehen ist. Unklare Begrifflichkeiten verstoßen gegen das Rechtsstaatsprinzip. Im Übrigen ist es nicht sinnvoll, ein u.U. in einer unklaren Situation vorgenommenes Verhalten mit intransparenten und unüber- sichtlichen Regelungen noch zusätzlich zu pönalisieren. Vielmehr sollten die ent- sprechenden Regelungen deutlich gefasst werden. 5. Gründung von Profit-Centern: Die Gründung solcher Profitcentern ist kritisch zu betrachten. Grundsätzlich sind Stel- len zur Bekämpfung von Fehlverhalten innerhalb der maßgebenden Organisationen sinnvoll und zu befürworten. Allerdings ist die Ausgestaltung dieser Stellen als Profit- Center nicht mit dem Rechtsstaatsprinzip zu vereinbaren. Eine Ermittlung bzw. Über- prüfung von möglichen Fehlverhalten muss ergebnisoffen erfolgen und es darf nicht der Anreiz geschaffen werden, – zur Legitimierung einer solchen Stelle – möglichst viele Korruptionsfälle zu finden. Dies fördert vielmehr eine Atmosphäre des Misstrau- ens und eine Kriminalisierung von Kooperationen und Zusammenarbeit. Bonn, 21. März 2012 Schm/Rü

Seite 1 von 2 Bonn/Berlin, 13. März 2012 Stellungnahme zum Entschließungsantrag des Landes Baden-Württemberg zur Allgemeinen Verwaltungsvorschrift zur Durchführung des Medizinproduktegesetzes (Medizinprodukte-Durchführungsvorschrift – MPGVwV) Nach dem o.g. Entschließungsantrag des Landes Baden-Württemberg soll der Bundesrat die Bundesregierung auffordern, die Überarbeitung des Medizinprodukterechts auf nationaler und europäischer Ebene entschlossen voranzubringen. Hintergrund sind die Vorfälle um die mit Silikon-Gel gefüllten Brustimplantate der Hersteller Poly Implant Prothèse (PIP) und Rofil Medical Nederland B.V. Das Land Baden-Württemberg zieht daraus folgende Maßnahmen in Betracht, die die Branchen- verbände Bundesverband der Arzneimittel-Hersteller e.V. (BAH) und der Industrieverband SPECTARIS wie folgt kommentieren:  „Einführung einer Zulassungspflicht für besonders risikobehaftete Medizinprodukte, beispiels- weise für Produkte, die dauerhaft im menschlichen Körper verbleiben;“ Brustimplantate sind Medizinprodukte der höchsten Risikoklasse. Um die Verkehrsfähigkeit dieser Produkte zu erlangen muss u.a. eine Benannte Stelle eine mit der behördlichen Zulassung vergleichbare Prüfung durchführen. Beim PIP-Skandal handelt es sich um das hochkriminelle Verhalten eines einzelnen Her- stellers, der bei der Prüfung seiner Produkte für die CE-Kennzeichnung medizinisches Silikon vorlegte, und erst nachträglich die Produktion umstellte und die minderwertigen Produkte mit billigem Industriesilikon in den Markt brachte. Eine Zulassungspflicht wird bei kriminellen Täuschungen keine Lösung darstellen: Arzneimittel sind nur mit einer behördlichen Zulassung verkehrsfähig. Dennoch kommt es auch hier vor, dass in Einzelfällen zugelassene Arzneimittel durch kriminelles Verhalten verunreinigt werden, z.B. indem nicht zugelassene Substanzen untergemischt werden. Hier kam es sogar bereits zu Todesfällen, ohne dass eine Zulassungspflicht daran etwas geändert hätte. Ferner hat das Bundesgesundheitsministerium bereits 2011 in seiner vergleichenden Analyse der Zulassung von Arzneimitteln und Medizinprodukten gezeigt, dass die Schutzziele – insbesondere die Patientensicherheit – bei Arzneimitteln und Medizinprodukten identisch sind und lediglich auf unterschiedlichem Wege erreicht werden. Der BAH und SPECTARIS lehnen deshalb den Vorschlag einer Zulassungspflicht entschieden ab. Seite 2 von 2  „Erhöhung der Anforderungen an klinische Prüfungen von Medizinprodukten bzw. Leistungs- bewertungsprüfungen;“ Die Anforderungen an klinische Prüfungen sind bereits durch die mit der MPKPV eingeführte Prüf- und Genehmigungspflicht sehr detailliert geregelt und mit den Vorschriften zu klinischen Prüfungen bei Arzneimitteln vergleichbar. Die Regelungen zur Durchführung klinischer Prü- fungen von Medizinprodukten in Deutschland gehören zu den umfangreichsten und schärfsten innerhalb der EU und weltweit. Einer weiteren Verschärfung bedarf es deshalb nicht. Schärfere Regelungen hätten kriminelle Täuschungsmanöver wie beim PIP-Skandal nicht verhindern können, da das minderwertige Silikon nach der Zulassung ausgetauscht wurde.  „Einführung einer Meldepflicht für Betriebe und Einrichtungen, welche besonders risikobehaftete Medizinprodukte, die dauerhaft im menschlichen Körper verbleiben, anwenden oder in den Verkehr bringen;“ Für die genannten Einrichtungen (Hersteller, Betreiber, Anwender) existieren bereits heute detaillierte Meldepflichten bei Vorkommnissen, siehe MPSV. Diese Meldungen sollten nach Ansicht der Branchenverbände der Medizinprodukte-Industrie auch in einer europaweiten zentralen Datenbank erfasst und analysiert werden (siehe Pressemitteilung vom 09.03.2012). Ebenso gibt es bereits eine Anzeigepflicht für Hersteller. „Darüber hinaus fordert der Bundesrat die Bundesregierung auf, - die Medizinprodukte-Sicherheitsplanverordnung dahingehend zu ändern, dass wichtige aktuelle Informationen von bundesweiter Bedeutung, speziell in Fällen, in denen eine rasche Information der Anwender erforderlich ist, nicht nur auf der Webseite des BfArM öffentlich zugänglich gemacht, sondern darüber hinaus auf Bundesebene aktiv an betroffene Organisationen und Fachgesellschaften kommuniziert werden sowie - zu evaluieren, ob das Meldeverhalten der Anwender von Medizinprodukten in Hinblick auf Vorkommnisse und Beinahe-Vorkommnisse den Vorgaben der Medizinprodukte- Sicherheitsplanverordnung gerecht wird und gegebenenfalls Wege aufzuzeigen, um das Meldeverhalten der Anwender von Medizinprodukten in Hinblick auf Vorkommnisse und Beinahe-Vorkommnisse zu verbessern.“ Der BAH und SPECTARIS begrüßen diesen Vorschlag ausdrücklich. In der Verbesserung der Meldepflicht sehen die Verbände einen effektiven Ansatz zur Stärkung der Patientensicherheit. Der tägliche Umgang der Anwender in den Kliniken und Praxen mit Medizinprodukten stellt die Basis für ein professionelles und weit verzweigtes Frühwarnsystem zur Identifizierung von gefährlichen Produkten im Markt dar. Der BAH und SPECTARIS verweisen hierbei auf die gemeinsame Pressemittelung der Branchenverbände der Medizinprodukte-Industrie vom 28.02.2012.

Medizinprodukte BAH-Kommentare zur anstehenden Entscheidung im Ministerrat Stoffliche Medizinprodukte sind Gesundheitsprodukte, die seit Jahren sicher angewendet werden und als „low-risk“ Produkte gelten. Dies schlägt sich ebenfalls in ihrer niedrigen Risikoklassifizierung (I/IIa) nieder, an die wiederum die regulatorischen Anforderungen bzw. der Marktzugang geknüpft sind. Die Abstimmung Europäischen Parlament am 22. Oktober 2013 und die erste Lesung am 2. April 2014 hat zumindest zu einigen wichtigen und positiven Anpassungen im Bereich stofflicher Medizinprodukte gegenüber dem Kommissionsvorschlag geführt. Der Ministerrat hat demgegenüber in seiner „Note“ vom 24.01.2014 zu erkennen gegeben, dass er sich dieser Meinung nicht anschließen wird. Einige Mitglieder wollen die Produkte gänzlich aus dem Anwendungsbereich des Medizinprodukterechts ausschließen, andere Länder unter- stützen eine Höherklassifizierung in die Risikoklasse III. Dies nimmt der BAH zum Anlass, noch einmal seine Kritik an den Kommissionsvorschlägen deutlich zu machen und besonders vier Punkte herauszustellen: 1. Keine Höherklassifizierung stofflicher Medizinprodukte Gemäß der von der Kommission vorgeschlagenen Regel 21 (Anhang VII) würde eine Vielzahl stofflicher Medizinprodukte in die höchste Risikoklasse eingeordnet (Klasse III). Diese Produkte (vgl. oben) sind in ihrem Risikopotential jedoch keineswegs mit Herzklappen oder Hirnelektroden vergleichbar und werden über die bereits bestehenden Regeln adäquat klassifiziert. Die risikobasierte Klassifizierung ist deshalb von entscheidender Bedeutung, da viele Anforderungen an den Marktzugang (Konformitätsbewertungsverfahren, klinische Bewertung etc.) hiervon abhängig sind. So könnten stoffliche Medizinprodukte als „Hochrisiko-Produkte“ künftig nur noch von Speziellen Benannten Stellen bewertet werden. Im EU-Parlament ist eine entsprechende Streichung der Regel 21 daher bereits ange- nommen worden. Der deutsche Vorschlag im Ministerrat, hier – gemäß dem Kommissionsvorschlag – die Aufnahme oder Verteilung der Stoffe im Körper als ent- scheidendes Kriterium heranzuziehen, ist nicht angemessen im Hinblick auf das geringe Risikopotential der in Frage stehenden Produkte. Potentielle Absorption von Spuren des Produktes kann es ebenso bei Implantaten jeder Art geben. Die Absorption des „physikalisch“ wirkenden Medizinprodukts ist nicht Teil der Zweckbestimmung bzw. der Wirk- weise des Medizinproduktes. Etwaige diesbezügliche Risiken werden bereits in der Risiko- bewertung und biologischen Bewertung des Produktes bewertet und minimiert. Daher sollte nach Auffassung des BAH nun auch im Ministerrat auf eine Streichung der Regel 21 ge- drängt werden, da der Kommissionsvorschlag auch an dieser Stelle unverhältnismäßig ist und einen risikobasierten Ansatz vermissen lässt. Falls eine vollständige Streichung nicht in Frage kommt, schlagen wir alternativ die folgende Formulierung vor: “Devices that are composed of substances or combination of substances primarily intended to be ingested, inhaled or administered rectally or vaginally and that are absorbed by and dispersed in the human body in order to achieve their intended purpose are: - In class IIa if they are intended for transient or short term use; - In class IIb if they are intended for long-term use” Seite 2 von 3 2. Keine Höherklassifizierung dentaler Füllmaterialien Die Höherklassifizierung Nanomaterial-haltiger Medizinprodukte aufgrund von Regel 19 des Kommissionsvorschlags soll nach der Einigung im EU-Parlament auf Produkte beschränkt werden, die beabsichtigt Nanomaterial freisetzen. Der BAH begrüßt diese Entscheidung. Durch die Regel 19, wie sie von der Kommission vorgeschlagen worden war, würden nahezu alle dentalen Medizinprodukte und darüber hinaus auch viele andere Medizinprodukte als Klasse III Produkte eingestuft. Viele Medizinprodukte, die heute noch als Produkte mit niedriger (Klasse I) oder mittlerer (Klasse IIa/IIb) Risikostufe gelten, wären zukünftig „Hochrisikoprodukte“ mit spezieller Zulassung. Daher schlägt der BAH eine Streichung der Regel vor bzw. unterstützt alternativ die vom EU-Parlament gewählte Lösung („intendierte Freisetzung“), wie oben dargestellt. Die Meinungen im Rat hinsichtlich der Regel 19 sind indes inhomogen, wie aus der „Note“ vom 24. Januar 2014 herauszulesen ist. Einige Länder unterstützen den Kommissions- vorschlag, andere stellen den Kommissionstext dahingehend in Frage, als es nicht für alle Produkte angemessen sei, sie in die Klasse III hochzustufen. Wiederum andere Länder - darunter auch Deutschland - wollen hinsichtlich der Komplexität der Thematik weitere Expertenmeinungen einholen. Dies nimmt der BAH zum Anlass, den deutschen Vertretern der Ratsarbeitsgruppe das von dem europäischen Dentalverband FIDE in Zusammenarbeit mit dem BAH ausgearbeitete Gutachten zu Nanomaterialien in dentalen Medizinprodukten zukommen zu lassen (siehe Anlage). 3. Medizinprodukte aus Gewebe oder Zellen menschlichen oder tierische Ursprungs – Redundanzen vermeiden Viele stoffliche Medizinprodukte enthalten Pharmagelatine, die auch im Arzneimittelbereich breite Anwendung findet (Hart- und Weichkapseln). Hergestellt wird die Gelatine aus dem Bindegewebe von Rindern. Detaillierte Spezifikationen zu potentiellen TSE-Risiken (Transmissible Spongiforme Enzephalopathie), die sich hieraus ergeben können, werden bereits durch die EU-Verordnung 722/2012 abgedeckt. Darüber hinaus muss die Sicherheit der eingesetzten Pharmagelatine durch ein EDQM-Zertifikat und durch die Konsultation mit der Behörde nachgewiesen werden. Trotzdem werden die betreffenden Produkte in die höchste Risikoklasse III eingestuft (Regel 17). Hier gibt es also Redundanzen, die zu keiner verbesserten Sicherheit beitragen. Nach Auffassung des EU-Parlamentes sollen diese Produkte nun auch noch als „Hochrisiko-Produkte“ reguliert werden. Aus den genannten Gründen sollte daher Regel 17 dahin gehend angepasst werden, dass ein Verweis auf die TSE-Verordnung aufgenommen wird und die Regelanwendung zu einer Klassifizierung in Klasse IIb führt. Wir schlagen daher die folgende Formulierung vor: All devices manufactured utilising tissues or cells of human or animal origin, or their derivatives, which are non-viable or rendered non-viable must fulfill the requirements of EU- Regulation 722/2012 and are in class IIb, unless such devices are manufactured utilising tissues or cells of animal origin, or their derivatives, which are non-viable or rendered non- viable that are intended to come into contact with intact skin only, in those cases they are class I. 4. Keine unnötigen Begleitpapiere in der Lieferkette – Bürokratie vermeiden Eine weitere Verschärfung ist jüngst durch das „Presidency proposal for Chapters II und III“ vom 22.01.2014 vorgebracht worden. In Art. 17 MDR heißt es dort: „The EU declaration of conformity shall state that fulfilment of the requirements specified in this Regulation has been demonstrated. It shall be continuously updated. The minimum content of the EU declaration of conformity is set out in Annex III. It shall accompany the device and be translated into Seite 3 von 3 thean official Union language or languages required by the Member State(s) in which the device is made available.” Korrespondierend hierzu soll in Art. 12 die Verpflichtung des Händlers aufgenommen werden, zu überprüfen, ob die EG-Konformitätserklärung dem Produkt beiliegt. Diese Ver- pflichtungen der Akteure in der Lieferkette stellt eine zusätzliche Belastung dar, ohne einen Mehrwert für die Patientensicherheit mit sich zu bringen. Bereits das CE-Kennzeichen sagt aus, dass das Produkt mit den Anforderungen der MP-Verordnung übereinstimmt. Dies besagt auch die Verordnung (EG) Nr. 765/20081. Hier heißt es in Art. 30 Abs. 4: „Die CE- Kennzeichnung ist die einzige Kennzeichnung, die die Konformität des Produkts mit den geltenden Anforderungen der einschlägigen Harmonisierungsvorschriften der Gemeinschaft, die ihre Anbringung vorschreibt, bescheinigt.“ Weitere „Begleitpapiere“ – wie etwa die EG- Konformitätserklärung – verbieten sich demnach. Auch in Sachen Fälschungsschutz bedarf es dieser zusätzlichen Papiere nicht. Denn um Fälschungen aufzudecken, wird mit der Medizinprodukte-Verordnung ein Unique Identification System (UDI) eingeführt. Wir schlagen daher vor, die Passage „accompany the device“ wie sie in Art. 17 zur Sprache gebracht wurde, zu streichen und Art. 12 Abs. 2 (des Kommissionsvorschlag) wie folgt zu formulieren (Fette, unterstrichene Passage neu): „Where a distributor considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, he shall not make the device available on the market until it has been brought into conformity. For this purpose he may request the EU declaration from the manufacturer. (…)” 1 Anlage 1 Verordnung (EG) Nr. 765/2008 des Europäischen Parlamentes und des Rates vom 09. Juli 2008 über die Vorschriften für die Akkreditierung und Marktüberwachung im Zusammenhang mit der Vermarktung von Produkten und zur Aufhebung der Verordnung (EWG) Nr. 339/93 des Rates.

P U BLI C Conseil UE 8343/14 LES/ns 1 LIMITE EN COUNCIL OF THE EUROPEAN UNION Brussels, 4 April 2014 Interinstitutional File: 2012/0266 (COD) 2012/0267 (COD) 8343/14 LIMITE PHARM 31 SAN 156 MI 322 COMPET 202 CODEC 958 REVISED NOTE from: General Secretariat to: Working Party on Pharmaceuticals and Medical Devices No. Cion prop.: 14493/12 PHARM 71 SAN 215 MI 597 COMPET 600 CODEC 2305 14499/12 PHARM 72 SAN 216 MI 598 COMPET 599 CODEC 2312 Subject: Proposal for a Regulation of the European Parliament and of the Council on Medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices – Presidency proposal for Chapters I Delegations will find in the Annexes Presidency draft texts for Chapter I of the proposal on medical devices and for Chapter I of the proposal on in vitro medical devices, submitted for their agreement. Annex A contains Chapter I of the medical devices proposal and Annex B Chapter I of the in vitro diagnostic medical devices proposal. Text Conventions: New text, added to the Commission proposal is indicated in bold italics. Deletions of text in the Commission proposal are indicated with strikethrough. ________________________ 8343/14 LES/ns 2 ANNEX A LIMITE EN ANNEX A Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 (Text with EEA relevance) Chapter I Scope and definitions Article 1 Scope 1. This Regulation establishes rules to be complied with by medical devices and accessories to medical devices that are placed when making available on the market or putting into service in the Union medical devices and accessories to medical devices for human use. For the purposes of this Regulation, medical devices and accessories to medical devices shall hereinafter be referred to as ‘devices’. 2. This Regulation shall not apply to: (a) in vitro diagnostic medical devices covered by Regulation (EU) […/…]; (b) medicinal products as defined in covered by Directive 2001/83/EC and advanced therapy medicinal products as defined in covered by Regulation (EC) No 1394/2007. In deciding whether a product falls under Directive 2001/83/EC or Regulation (EC) No 1394/2007 or under this Regulation, particular account shall be taken of the principal mode of action of the product shall be taken into account in particular. (c) human blood, blood products, plasma or blood cells of human origin or devices which incorporate, when placed on the market or used in accordance with the manufacturer's instructions, such blood products, plasma or cells, except for devices referred to in paragraph 4; (d) cosmetic products covered by Regulation (EC) No 1223/2009; 8343/14 LES/ns 3 ANNEX A LIMITE EN (e) transplants, tissues or cells of human or animal origin or their derivatives, or products containing or consisting of them, unless a device is manufactured utilising tissues or cells of human or animal origin, or their derivatives, which are non-viable or are rendered non-viable. However, human tissues and cells that are non-viable or are rendered non-viable and that have undergone only non-substantial manipulation, in particular those listed in Annex I of Regulation (EC) No 1394/2007, and products derived from such tissues and cells which function as an accessory to the medical device, shall not be considered devices manufactured utilising tissues or cells of human origin or their derivatives and this Regulation shall therefore apply; (f) products that intentionally contain or consist of biological substances or organisms other than those referred to in points (c) and (e) that are viable when introduced into the human body, including living micro-organisms, bacteria, fungi or virus; (g) food covered by Regulation (EC) No 178/2002. (h) products intended to be ingested, inhaled or administered orally, vaginally or rectally which shall fall under Directive 2001/83/EC. 3. Any device which, when placed on the market or used in accordance with the manufacturer's instructions, incorporates as an integral part an in vitro diagnostic medical device as defined in Article 2 of Regulation (EU) […/...] [on in vitro diagnostic medical devices] shall be governed by this Regulation, unless it is covered by Article 1(3) of that Regulation. The relevant general safety and performance requirements set out in Annex I of that Regulation shall apply as far as the safety and performance of the in vitro diagnostic medical device part are concerned. 8343/14 LES/ns 4 ANNEX A LIMITE EN 4. Where a device, when placed on the market or used in accordance with the manufacturer's instructions, incorporates, as an integral part, a substance which, if used separately, would be considered to be a medicinal product as defined in Article 1(2) of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma as defined in Article 1(10) of that Directive, with action ancillary to that of the device, that device shall be assessed and authorised in accordance with this Regulation. For the purposes of this paragraph, it shall be considered that a device incorporates a medicinal substance as an integral part, if the device and the substance are physically or chemically combined at the time of use. However, if the action of the medicinal substance is principal, not ancillary to that of the device, the product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004, as applicable. In this case, the relevant general safety and performance requirements set out in Annex I of this Regulation shall apply as far as the safety and performance of the device part are concerned. 5. Where a device is intended to administer a medicinal product as defined in Article 1(2) of Directive 2001/83/EC, that device shall be governed by this Regulation, without prejudice to the provisions of Directive 2001/83/EC and Regulation (EC) No 726/2004 with regard to the medicinal product. However, if the device intended to administer a medicinal product and the medicinal product are placed on the market in such a way that they form a single integral product which is intended exclusively for use in the given combination and which is not reusable, the product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004, as applicable. In this case, the relevant general safety and performance requirements set out in Annex I of this Regulation shall apply as far as the safety and performance of the device part are concerned. 6. This Regulation is a specific Union legislation within the meaning of Article 1(4) of Directive 2004/108/EC and within the meaning of Article 3 of Directive 2006/42/EC. 8343/14 LES/ns 5 ANNEX A LIMITE EN 7. This Regulation shall not affect the application of Council Directive 96/29/Euratom nor of Council Directive 97/43/Euratom. 8. This Regulation shall not affect national laws which require that inter alia certain devices may only be supplied on a medical prescription. 9. References to a Member State in this Regulation shall be understood as also including any other country with which the Union has concluded an agreement which confers on that country the same status as a Member State for the purpose of application of this Regulation. Article 2 Definitions 1. For the purposes of this Regulation, the following definitions shall apply: Definitions related to devices: (1) ‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article, including reagents, reagent products, calibrators, control materials, kits or systems for in vitro use, and other products, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific medical purposes of: – diagnosis, prevention, monitoring, treatment or alleviation of disease, – diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability, – investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, – control or support of conception, – disinfection or sterilisation of any of the above-mentioned products, 8343/14 LES/ns 6 ANNEX A LIMITE EN – provision of information concerning a physiological or pathological process or state, a congenital abnormality, the predisposition to a medical condition or a disease, or to determine the safety and compatibility with potential recipients, to predict treatment response or reactions or to define or monitor therapeutic measures by means of in vitro examination of specimens derived from the human body, including blood and tissue donations. and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means. Agents for transport, nutrition and storage of organs, tissues and cells intended for transplantation shall be considered medical devices, regardless of principal mode of action of the product. The implantable or other invasive products, or products for delivering significant amounts and/or intensities of energy onto or into the human body, intended to be used for human beings, which are listed in Annex XV shall be considered medical devices, regardless of whether or not they are intended by the manufacturer to be used for a medical purpose. (2) ‘accessory to a medical device’ means an article which, whilst not being a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable or assist the device(s) to be used in accordance with its/their intended purpose(s); 8343/14 LES/ns 7 ANNEX A LIMITE EN (3) ‘custom-made device’ means any device specifically made in accordance with a written prescription of a doctor of medicine, of a dental practitioner or of any other person authorised by national law by virtue of this person's professional qualifications which gives, under his responsibility, specific design characteristics, and is intended for the sole use of a particular patient. However, mass-produced devices which need to be adapted to meet the specific requirements of a medical doctor of medicine, a dental practitioner or any other professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of medical doctors of medicine, dental practitioners or any other authorised person shall not be considered to be custom-made devices; (4) ‘active device’ means any device, the operation of which depends on a source of electrical energy or any source of power other than that directly generated by gravity and which acts by changing the density of or converting this energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be considered to be active devices. Stand alone software shall be considered an active device; (5) ‘implantable device’ means any device, including those that are partially or wholly absorbed, which is intended – to be totally introduced into the human body or – to replace an epithelial surface or the surface of the eye, by clinical intervention and which is intended to remain in place after the procedure. Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be considered an implantable device; 8343/14 LES/ns 8 ANNEX A LIMITE EN (6) ‘invasive device’ means any device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body; (7) ‘generic device group’ means a set of devices having the same or similar intended purposes or commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics; (8) ‘single-use device’ means a device that is intended to be used on an individual patient during a single procedure. The single procedure may involve several uses or prolonged use on the same patient; (9) ‘single-use device for critical use’ means a single-use device intended to be used for surgically invasive medical procedures; (9a) ‘device for aesthetic purposes’ means any instrument, apparatus, appliance, software, implant, material, substance or other article, intended by the manufacturer to be used, alone or in combination, for human beings for the purpose of modifying physical appearance, without a therapeutic or reconstructive purpose, by means of implantation in the human body, by adhering to the surface of the eye, or by inducing a reaction in tissues or cells on the external or other parts of the human body. Tattooing and piercing products shall not be considered devices for aesthetic purposes. (10) ‘intended purpose’ means the use for which the device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements; (11) ‘label’ means the written, printed, or graphic information appearing either on the device itself, or on the packaging of each unit or on the packaging of multiple devices; (12) ‘instructions for use’ means the information provided by the manufacturer to inform the user of the device’s intended purpose and proper use and of any precautions to be taken; 8343/14 LES/ns 9 ANNEX A LIMITE EN (13) ‘Unique Device Identification’ (‘UDI’) means a series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market; (14) ‘non-viable’ means having no potential for metabolism or multiplication; (15) ‘nanomaterial’ means a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm. Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm shall be considered as nanomaterials. For the purposes of the definition of nanomaterial, ‘particle’, ‘agglomerate’ and ‘aggregate’ are defined as follows: – ‘particle’ means a minute piece of matter with defined physical boundaries; – ‘agglomerate’ means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components; – ‘aggregate’ means a particle comprising of strongly bound or fused particles; Definitions related to the making available of devices: (16) ‘making available on the market’ means any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge; (17) ‘placing on the market’ means the first making available of a device, other than an investigational device, on the Union market; (18) ‘putting into service’ means the stage at which a device, other than an investigational device, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose; 8343/14 LES/ns 10 ANNEX A LIMITE EN Definitions related to economic operators, users and specific processes: (19) ‘manufacturer’ means the natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under his name or trademark. For the purposes of the definition of manufacturer, fully refurbishing is defined as the complete rebuilding of a device already placed on the market or put into service, or the making of a new device from used devices, to bring it in conformity with this Regulation, combined with the assignment of a new lifetime to the refurbished device; (20) ‘authorised representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer to act on his behalf in relation to specified tasks with regard to the latter's obligations under this Regulation; (21) ‘importer’ means any natural or legal person established within the Union who places a device from a third country on the Union market; (22) ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a device available on the market; (23) ‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor; (24) ‘health institution’ means an organisation whose primary purpose is the care or treatment of patients or the promotion of public health; (25) ‘user’ means any healthcare professional or lay person who uses a device; (26) ‘lay person’ means an individual who does not have formal education in a relevant field of healthcare or medical discipline; 8343/14 LES/ns 11 ANNEX A LIMITE EN (27) ‘reprocessing’ means the process carried out on a used device in order to allow its safe reuse including cleaning, disinfection, sterilisation and related procedures, as well as testing and restoration of the technical and functional safety of the used device; Definitions related to conformity assessment: (28) ‘conformity assessment’ means the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled; (29) ‘conformity assessment body’ means a body that performs third-party conformity assessment activities including calibration, testing, certification and inspection; (30) ‘notified body’ means a conformity assessment body designated in accordance with this Regulation; (31) ‘CE marking of conformity’ or ‘CE marking’ means a marking by which the manufacturer indicates that the device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing; Definitions related to clinical evaluation and clinical investigations: (32) ‘clinical evaluation’ means the assessment and analysis of clinical data pertaining to a device in order to verify the safety and performance of the device when used as intended by the manufacturer; (33) ‘clinical investigation’ means any systematic investigation in one or more human subjects, undertaken to assess the safety or performance of a device; (34) ‘investigational device’ means any device being assessed for safety and/or performance in a clinical investigation; (35) ‘clinical investigation plan’ means the document(s) setting out the rationale, objectives, design and proposed analysis, methodology, monitoring, conduct and record-keeping of the clinical investigation; 8343/14 LES/ns 12 ANNEX A LIMITE EN (36) ‘clinical data’ means the information concerning the safety or performance that is generated from the use of a device and that are sourced from the following: – clinical investigation(s) of the device concerned, – clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, – published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated; (37) ‘sponsor’ means an individual, legal or physical person, company, institution or organisation who ich takes responsibility for the initiation and management setting up the financing of a clinical investigation; (37a) ‘subject’ means an individual who participates in a clinical investigation either as recipient of an investigational product or as control; (37b) ‘clinical evidence’ means clinical data of sufficient amount and quality to allow a qualified assessment of whether the device achieves the intended clinical benefit(s) and safety, when used as intended by the manufacturer; (37c) ‘clinical performance’ means any direct or indirect medical effects on humans as well as the clinical benefit on patients resulting from the technical or functional, including diagnostic characteristics of a device, when used as intended by the manufacturer; (37d) ‘clinical benefit’ means the positive impact of a device on the health of an individual, to be specified as meaningful, measurable, patient-relevant clinical outcome(s), including outcome(s) related to diagnosis or a positive impact on patient management or public health, inter alia through the use of diagnostic devices for screening. 8343/14 LES/ns 13 ANNEX A LIMITE EN (37e) ‘efficacy’ means the ability of a medical device to achieve the intended clinical benefit(s) to patients, in the intended target group(s), when the device is used as intended by the manufacturer, under ideal circumstances (as in a pre-market clinical investigation). (37f) ‘effectiveness’ means the ability of a medical device to achieve the intended clinical benefit(s) to patients, in the intended target group(s), when the device is used as intended by the manufacturer, under normal circumstances of health care practices. (37g) ‘equivalence’ means the ability of two or more devices to have similar technical, biological and clinical characteristics, when used as intended by their respective manufacturers, to such an extent that there would be not a clinically significant difference in the safety and performance of the devices. (38) ‘adverse event’ means any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device; (39) ‘serious adverse event’ means any adverse event that led to any of the following: – death, – serious deterioration in the health of the subject, that resulted in any of the following: (i) life-threatening illness or injury, (ii) permanent impairment of a body structure or a body function, (iii) hospitalisation or extending the duration of hospitalisation, (iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, – foetal distress, foetal death or a congenital abnormality or birth defect; 8343/14 LES/ns 14 ANNEX A LIMITE EN (40) ‘device deficiency’ means any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in the information supplied by the manufacturer; Definitions related to vigilance and market surveillance: (40a) ‘Post Market Surveillance’ means all activities carried out by the manufacturers and other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from their devices placed on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrections, corrective or preventive actions. (41) ‘recall’ means any measure aimed at achieving the return of a device that has already been made available to the end user; (42) ‘withdrawal’ means any measure aimed at preventing a device in the supply chain from further being made available on the market; (43) ‘incident’ means any malfunction or deterioration in the characteristics or performance of a device made available on the market including use-error, any inadequacy in the information supplied by the manufacturer and any unexpected undesirable side-effect; (44) ‘serious incident’ means any incident that directly or indirectly led, might have led or might lead to any of the following: – death of a patient, user or other person, – temporary or permanent serious deterioration of the patient's, user's or other person's state of health, – serious public health threat; (44a) 'serious public health threat' means any event which results in imminent risk of death, serious deterioration in state of health, or serious illness that requires prompt remedial action; 8343/14 LES/ns 15 ANNEX A LIMITE EN (45) ‘corrective action’ means action taken to eliminate the cause of a potential or real non- conformity or other undesirable situation including product design modifications as well as modifications concerning the production process or technique; (46) ‘field safety corrective action’ means corrective action taken by the manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market; (47) ‘field safety notice’ means the communication sent by the manufacturer to users or customers in relation to a field safety corrective action; (48) ‘market surveillance’ means the activities carried out and measures taken by public authorities to check and ensure that products devices comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection; (48a) ‘vigilance’ means activities carried out by public authorities to systematically collect information on risks of devices available on the EU market, to assess this information and the underlying risks and measures taken to ensure that devices do not endanger health, safety or any other aspect of public health. Definitions related to standards and other technical specifications: (49) ‘harmonised standard’ means a European standard as defined in Article 2(1)(c) of Regulation (EU) No […/…]; (50) ‘common technical specifications’ means a document other than a standard that prescribes technical requirements that provide a means to comply with the legal obligation applicable to a device, process or system. 8343/14 LES/ns 16 ANNEX A LIMITE EN 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 89 to amend the list in Annex XV referred to in the last subparagraph of number (1) of paragraph 1, in the light of technical progress and taking into account the similarity between a medical device and a product without a medical purpose in respect of their characteristics and risks. 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 89 in order to adapt the definition of nanomaterial set out in number (15) of paragraph 1 in view of technical and scientific progress and taking into account definitions agreed at Union and international level. 8343/14 LES/ns 17 ANNEX B LIMITE EN ANNEX B 2012/0267 (COD) Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on in vitro diagnostic medical devices (Text with EEA relevance) Chapter I Scope and definitions Article 1 Scope 1. This Regulation establishes rules to be complied with by in vitro diagnostic medical devices and accessories to in vitro diagnostic medical devices that are placed when making available on the market or putting into service in the Union in vitro diagnostic medical devices and accessories to in vitro diagnostic medical devices for human use. For the purposes of this Regulation, in vitro diagnostic medical devices and accessories to in vitro diagnostic medical devices shall hereinafter be referred to as 'devices'. 2. This Regulation shall not apply to: (a) products for general laboratory use, unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination; (b) invasive sampling devices or those which are directly applied to the human body for the purpose of obtaining a specimen; (c) higher metrological order internationally certified reference materials. (d) materials used for external quality assessment schemes (e) research-use only products 8343/14 LES/ns 18 ANNEX B LIMITE EN 3. Any device which, when placed on the market or used in accordance with the manufacturer's instructions, incorporates as an integral part a medical device as defined in Article 2 of Regulation (EU) [Ref. of future Regulation on medical devices] on medical devices without being an in vitro diagnostic medical device, shall be governed by this Regulation, provided that the principal intended purpose of the combination is that of an in vitro diagnostic medical device referred to in Article 2(2) of this Regulation. The relevant general safety and performance requirements set out in Annex I to Regulation (EU) [Ref. of future Regulation on medical devices] shall apply as far as the safety and performance of the medical device part that is not an in vitro diagnostic medical device are concerned. 4. This Regulation is a specific Union legislation within the meaning of Article 1(4) of Directive 2004/108/EC and within the meaning of Article 3 of Directive 2006/42/EC. 5. This Regulation shall not affect the application of Council Directive 96/29/Euratom, nor of Council Directive 97/43/Euratom. 6. This Regulation shall not affect national laws which require that inter alia certain devices may only be supplied on a medical prescription. 7. References to a Member State in this Regulation shall be understood as also including any other country with which the Union has concluded an agreement which confers on that country the same status as a Member State for the purpose of application of this Regulation. 8343/14 LES/ns 19 ANNEX B LIMITE EN Article 2 Definitions For the purposes of this Regulation, the following definitions shall apply: Definitions related to devices: (1) ‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article, including reagents, reagent products, calibrators, control materials, kits or systems for in vitro use, and other products intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific medical purposes of: – diagnosis, prevention, monitoring, treatment or alleviation of disease, – diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability, – investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, – control or support of conception, – disinfection or sterilisation of any of the above-mentioned products, – providing information concerning a physiological or pathological process or state, a congenital abnormality, the predisposition to a medical condition or a disease, or to determine the safety and compatibility with potential recipients, to predict treatment response or reactions or to define or monitor therapeutic measures by means of in vitro examination of specimens derived from the human body, including blood and tissue donations; and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means. 8343/14 LES/ns 20 ANNEX B LIMITE EN (2) 'in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information: – concerning a physiological or pathological process or state; – concerning a congenital abnormality; – concerning the predisposition to a medical condition or a disease; – to determine the safety and compatibility with potential recipients; – to predict treatment response or reactions; – to define or monitor therapeutic measures. Specimen receptacles are considered to be in vitro diagnostic medical devices. For the purposes of this Regulation, ‘specimen receptacle’ means devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination. (3) 'accessory to an in vitro diagnostic medical device' means an article which, whilst not being an in vitro diagnostic medical device, is intended by its manufacturer to be used together with one or several particular in vitro diagnostic medical device(s) to specifically enable or assist the in vitro diagnostic medical device(s) to be used in accordance with its/their intended purpose(s); (3a) ‘invasive device’ means any device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body; (4) 'device for self-testing' means any device intended by the manufacturer to be used by lay persons; (5) 'device for near-patient testing' means any device that is not intended for self-testing but is intended to perform testing outside a laboratory environment, generally near to, or at the side of, the patient; 8343/14 LES/ns 21 ANNEX B LIMITE EN (6) 'companion diagnostic' means a device specifically intended to select patients with a previously diagnosed condition or predisposition as eligible for a targeted therapy; (7) 'generic device group' means a set of devices having the same or similar intended purposes or commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics; (8) 'single-use device' means a device that is intended to be used on an individual patient during a single procedure; The single procedure may involve several uses or prolonged use on the same patient. (8a) 'kit' means a set of components that are packaged together and intended to be used to perform a specific in vitro diagnostic examination, or a part thereof (9) 'intended purpose' means the use for which the device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements; (10) 'label' means the written, printed, or graphic information appearing either on the device itself, or on the packaging of each unit, or on the packaging of multiple devices; (11) 'instructions for use' means the information provided by the manufacturer to inform the user of the device’s intended purpose and proper use and of any precautions to be taken; (12) 'Unique Device Identification' ('UDI') means a series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market; 8343/14 LES/ns 22 ANNEX B LIMITE EN Definitions related to the making available of devices: (13) 'making available on the market' means any supply of a device, other than a device for performance evaluation, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge; (14) 'placing on the market' means the first making available of a device, other than a device for performance evaluation, on the Union market; (15) 'putting into service' means the stage at which a device, other than a device for performance evaluation, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose; Definitions related to economic operators, users and specific processes: (16) 'manufacturer' means the natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under his name or trademark. For the purposes of the definition of manufacturer, fully refurbishing is defined as the complete rebuilding of a device already placed on the market or put into service, or the making of a new device from used devices, to bring it in conformity with this Regulation, combined with the assignment of a new lifetime to the refurbished device; (17) 'authorised representative' means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer to act on his behalf in relation to specified tasks with regard to the latter's obligations under this Regulation; (18) 'importer' means any natural or legal person established within the Union who places a device from a third country on the Union market; (19) 'distributor' means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a device available on the market; (20) 'economic operators' means the manufacturer, the authorised representative, the importer and the distributor; 8343/14 LES/ns 23 ANNEX B LIMITE EN (21) 'health institution' means an organisation whose primary purpose is the care or treatment of patients or the promotion of public health; (22) 'user' means any healthcare professional or lay person who uses a device; (23) 'lay person' means an individual who does not have formal education in a relevant field of healthcare or medical discipline; Definitions related to conformity assessment: (24) 'conformity assessment' means the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled; (25) 'conformity assessment body' means a body that performs third-party conformity assessment activities including calibration, testing, certification and inspection; (26) 'notified body' means a conformity assessment body designated in accordance with this Regulation; (27) 'CE marking of conformity' or 'CE marking' means a marking by which the manufacturer indicates that the device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing; Definitions related to clinical evidence: (28) 'clinical evidence' means the information that supports the scientific validity and performance for the use of a device as intended by the manufacturer; (29) 'scientific validity of an analyte' means the association of an analyte to a clinical condition or a physiological state; (30) 'performance of a device' means the ability of a device to achieve its intended purpose as claimed by the manufacturer. It consists of the analytical and, where applicable, the clinical performance supporting the intended purpose of the device; 8343/14 LES/ns 24 ANNEX B LIMITE EN (31) 'analytical performance' means the ability of a device to correctly detect or measure a particular analyte; (32) 'clinical performance' means the ability of a device to yield results that are correlated with a particular clinical condition or a physiological state in accordance with the target population and intended user; (33) 'clinical performance study’ means a study undertaken to establish or confirm the clinical performance of a device; (34) 'clinical performance study protocol' means the document(s) setting out the rationale, objectives, design and proposed analysis, methodology, monitoring, conduct and record- keeping of the clinical performance study; (35) 'performance evaluation' means the assessment and analysis of data to establish or verify the analytical and, where applicable, the clinical performance of a device; (36) 'device for performance evaluation' means a device intended by the manufacturer to be subject to one or more performance evaluation studies in laboratories for medical analyses or in other appropriate environments outside the manufacturer's own premises. Devices intended to be used for research purposes, without any medical objective, are not regarded as devices for performance evaluation; (37) 'interventional clinical performance study' means a clinical performance study where the test results may influence patient management decisions and/or may be used to guide treatment; (38) 'diagnostic specificity' means the ability of a device to recognize the absence of a target marker associated with a particular disease or condition; (39) 'diagnostic sensitivity' means the ability of a device to identify the presence of a target marker associated with a particular disease or condition; 8343/14 LES/ns 25 ANNEX B LIMITE EN (40) 'predictive value' means the probability that a person with a positive device test result has a given condition under investigation, or that a person with a negative device test result does not have a given condition; (41) 'positive predictive value' means the ability of a device to separate true positive results from false positive results for a given attribute in a given population; (42) 'negative predictive value' means the ability of a device to separate true negative results from false negative results for a given attribute in a given population; (43) 'likelihood ratio' means the likelihood that a given result would be expected in an individual with the target clinical condition or physiological state compared to the likelihood that the same result would be expected in an individual without that clinical condition or physiological state; (44) 'calibrators and control materials' means any substance, material or article intended by the manufacturer either to establish measurement relationships or to verify the performance characteristics of a device in conjunction with the intended purpose of that device; (45) 'sponsor' means any individual, company, institution or organisation which takes responsibility for the initiation and management of a clinical performance study; (45a) equivalence means the ability of two or more devices to have similar clinical and analytical characteristics when used as intended by their respective manufacturer, to such an extent that there would be not a clinically significant difference in the performance of the devices. (46) 'adverse event' means any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons in the context of a clinical performance study, whether or not related to the device for performance evaluation; 8343/14 LES/ns 26 ANNEX B LIMITE EN (47) 'serious adverse event' means any adverse event that led to any of the following: – death, – serious deterioration in the health of the subject, that resulted in any of the following: (i) life-threatening illness or injury, (ii) permanent impairment of a body structure or a body function, (iii) hospitalisation or extending the duration of hospitalisation, (iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, – foetal distress, foetal death or a congenital abnormality or birth defect. (48) 'device deficiency' means any inadequacy in the identity, quality, durability, reliability, safety or performance of a device for performance evaluation, including malfunction, use errors or inadequacy in the information supplied by the manufacturer; Definitions related to vigilance and market surveillance: (48a) ‘Post Market Surveillance’ means all activities carried out by the manufacturers and other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from their devices placed on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrections, corrective or preventive actions. (49) 'recall' means any measure aimed at achieving the return of a device that has already been made available to the end user; (50) 'withdrawal' means any measure aimed at preventing a device in the supply chain from further being made available on the market; (51) 'incident' means any malfunction or deterioration in the characteristics or performance of a device made available on the market including use-error, , any inadequacy in the information supplied by the manufacturer and any unexpected undesirable effect; 8343/14 LES/ns 27 ANNEX B LIMITE EN (52) 'serious incident' means any incident that directly or indirectly led, might have led or might lead to any of the following: – death of a patient, user or other person, – temporary or permanent serious deterioration of the patient's, user's or other person's state of health, – serious public health threat; (52a) 'serious public health threat' means any event which results in imminent risk of death, serious deterioration in state of health, or serious illness that requires prompt remedial action; (53) 'corrective action' means action taken to eliminate the cause of a potential or real non- conformity or other undesirable situation including product design modifications as well as modifications concerning the production process or technique; (54) 'field safety corrective action' means corrective action taken by the manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market; (55) 'field safety notice' means the communication sent by the manufacturer to users or customers in relation to a field safety corrective action; (56) 'market surveillance' means the activities carried out and measures taken by public authorities to check and ensure that products devices comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection; (56a) ‘vigilance’ means activities carried out by public authorities to systematically collect information on risks of devices available on the EU market, to assess this information and the underlying risks and measures taken to ensure that devices do not endanger health, safety or any other aspect of public health. 8343/14 LES/ns 28 ANNEX B LIMITE EN Definitions related to standards and other technical specifications: (57) ‘harmonised standard’ means a European standard as defined in Article 2(1)(c) of Regulation (EU) No [Ref. of future Regulation on European standardisation]; (58) 'common technical specifications’ means a document other than a standard that prescribes technical requirements that provide a means to comply with the legal obligations applicable to a device, process or system. _______________________ REVISED NOTE

P U BLI C Conseil UE 7315/14 LES/ns 1 DG B 4B LIMITE EN COUNCIL OF THE EUROPEAN UNION Brussels, 3 April 2014 Interinstitutional File: 2012/0266 (COD) 2012/0267 (COD) 7315/14 LIMITE PHARM 23 SAN 117 MI 236 COMPET 156 CODEC 654 NOTE from: General Secretariat to: Working Party on Pharmaceuticals and Medical Devices No. Cion prop.: 14493/12 PHARM 71 SAN 215 MI 597 COMPET 600 CODEC 2305 + COR 1 14499/12 PHARM 72 SAN 216 MI 598 COMPET 599 CODEC 2312 + COR 1 Subject: Proposal for a Regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices – Presidency proposal for Chapter VIII Delegations will find in the Annex a Presidency draft text for Chapter VIII of the proposal on medical devices, submitted for their agreement. The changes proposed to the Commission proposal should also be applicable to the corresponding articles of the proposal on in vitro medical devices. Text Conventions: New text, added to the Commission proposal is indicated in bold italics. Deletions of text in the Commission proposal are indicated with strikethrough. ________________________ 7315/14 LES/ns 2 ANNEX LIMITE EN ANNEX Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 (Text with EEA relevance) Chapter VIII Cooperation between Member States, Medical Device Coordination Group, EU reference laboratories, device registers Article 76 Competent authorities 1. The Member States shall designate the competent authority or authorities responsible for the implementation of this Regulation. They shall entrust their authorities with the powers, resources, equipment and knowledge necessary for the proper performance of their tasks pursuant to this Regulation. The Member States shall communicate the names and contact details of the competent authorities responsible for the implementation of this Regulation to the Commission which shall publish a list of competent authorities. 2. For the implementation of Articles 50 to 60, the Member States may designate a national contact point other than a national authority. In this case, references to a competent authority in this Regulation shall be understood as including the national contact point. Article 77 Cooperation 1. The competent authorities of the Member States shall cooperate with each other and with the Commission and exchange with each other the information necessary to enable this Regulation to be applied uniformly. 7315/14 LES/ns 3 ANNEX LIMITE EN 2. Member States and the Commission shall participate, where appropriate, in initiatives developed at international level with the aim of ensuring cooperation between regulatory authorities in the field of medical devices. Article 78 Medical Device Coordination Group 1. With a view to facilitating the uniform application of this Regulation by the Member States, a A Medical Device Coordination Group (MDCG) is hereby established. 2. Each Member State shall appoint, for a three-year term which may be renewed, one member and one alternate providing expertise in the field of this Regulation, and one member and one alternate providing expertise in the field of Regulation (EU) No […/…] [on in vitro diagnostic medical devices]. A Member State may choose to appoint only one member and one alternate providing expertise in both fields. The members of the MDCG shall be chosen for their competence and experience in the field of medical devices and in vitro diagnostic medical devices. They shall represent competent authorities of the Member States and convey the expertise gained in MDCG back to those authorities. The names and affiliation of members shall be made public by the Commission. The alternates shall represent and vote for the members in their absence. 3. The MDCG shall meet at regular intervals and, where the situation requires, upon a request from the Commission or a Member State. The meetings shall be attended either by the members appointed for their role and expertise in the field of this Regulation, or by the members appointed for their expertise in the field of Regulation (EU) No […/…] [on in vitro diagnostic medical devices], or by the members appointed for both Regulations, or their alternates, as appropriate. 4. The MDCG shall use its best endeavours to reach consensus. If such consensus cannot be reached, the MDCG shall decide adopt an opinion consisting of the position of by the majority of its members. Members with diverging positions may request that their positions and the grounds on which they are based arebe recorded in the MDCG's position opinion. 7315/14 LES/ns 4 ANNEX LIMITE EN 4a. The MDCG opinions shall be forwarded for information to the Committee on Medical Devices referred to in Article 88. 5. The MDCG shall be chaired by a representative of the Commission. The chair shall not take part in votes of the MDCG. 6. The MDCG may invite, on a case-by-case basis, experts and other third parties to attend meetings or provide written contributions. 7. The MDCG may establish and utilise standing or temporary sub-groups. Where appropriate, organisations representing the interests of the medical device industry, healthcare professionals, laboratories, patients and consumers at Union level shall be invited in such sub- groups in the capacity of observers. 7a. In particular, the MDCG may establish and utilise device panels (DP) for certain tasks. Device panels shall be composed of representatives of leading European scientific societies in the field, including representatives of relevant device register institutions[, and be organized by the Joint Research Centre on behalf of the Commission]. DP Members shall be appointed on the basis of scientific competence. The MDCG shall establish DPs for specific medical areas as well as a general clinical DP which shall deal with devices not covered by the DPs for specific medical areas. 8. The MDCG shall, on the basis of a draft drawn up by the Commission, establish its rules of procedure which shall, in particular, lay down procedures for the following: – the adoption of opinions or recommendations or other positions by the MDCG, including in cases of urgency; – the delegation of tasks to reporting and co-reporting members; – the functioning of sub-groups and Device Panels. The rules of procedure shall enter into force after receiving a favourable opinion from the Commission. 7315/14 LES/ns 5 ANNEX LIMITE EN Article 79 Support by the Commission The Commission shall support the functioning of the cooperation between national competent authorities and provide technical, scientific, financial and logistic support to the MDCG and its sub-groups and Device Panels. It shall organise the meetings of the MDCG and its sub-groups and Device Panels, participate in those meetings and ensure the appropriate follow-up. Article 80 Tasks of the MDCG The MDCG shall have the following tasks: (a) to contribute to the assessment of applicant conformity assessment bodies and notified bodies pursuant to the provisions set out in Chapter IV; (b) to adopt opinions to be provided to notified bodies as part of the to contribute to the scrutiny of certain conformity assessments pursuant to for devices listed in Article 44a(1); (c) to contribute to the development of guidance aimed at ensuring effective and harmonised implementation of this Regulation, in particular regarding the designation and monitoring of notified bodies, application of the general safety and performance requirements and conduct of the clinical evaluation and investigations by manufacturers and the assessment by notified bodies; (ca) to continuously monitor the technical progress and assess whether the essential requirements on safety and performance provided in this Regulation and Regulation (EU) No […/…] [on in vitro diagnostic medical devices] are appropriate to ensure safety and performance of medical devices and identify the need to amend Annex I; (cb) to contribute to the development of medical devices standards and of Common (Technical) Specification (d) to assist the competent authorities of the Member States in their coordination activities in the fields of classification of medical devices, clinical investigations, vigilance and market surveillance including the development and maintenance of a framework for a European market surveillance program with the objective of efficiency and harmonisation of market surveillance in the European Union, in accordance with article 67; (e) to provide advice and assist the Commission, either on its own initiative or at its request of the Commission, in its assessment of any issue related to the implementation of this Regulation; 7315/14 LES/ns 6 ANNEX LIMITE EN (f) to contribute to harmonised administrative practice with regard to medical devices in the Member States. Article 81 European Union reference laboratories 1. For specific devices, or a category or group of devices, or for specific hazards related to a category or group of devices, the Commission may designate, by means of implementing acts, one or more European Union reference laboratories, hereinafter referred to as 'EU reference laboratories', that satisfy the criteria set out in paragraph 3. The Commission shall only designate laboratories for which a Member State or the Commission's Joint Research Centre have submitted an application for designation. 2. Within the scope of their designation, the EU reference laboratories shall, where appropriate, have the following tasks: (a) to provide scientific and technical assistance to the Commission, the MDCG, the Member States and notified bodies in relation to the implementation of this Regulation; (b) to provide scientific advice regarding the state of the art in relation to specific devices, or a category or group of devices; (c) to set up and manage a network of national reference laboratories after consulting with the national authorities and publish a list of the participating national reference laboratories and their respective tasks; (d) to contribute to the development of appropriate testing and analysis methods to be applied for conformity assessment procedures and market surveillance; (e) to collaborate with notified bodies in the development of best practices for the performance of conformity assessment procedures; (f) to contribute to the development of standards at international level; (g) to provide scientific opinions in response to consultations by notified bodies in accordance with this Regulation and publish them by electronic means after consideration of national provisions on the respect of confidentiality. 7315/14 LES/ns 7 ANNEX LIMITE EN 3. EU reference laboratories shall satisfy the following criteria: (a) to have adequate and appropriately qualified staff with adequate knowledge and experience in the field of the medical devices for which they are designated; (b) to possess the necessary equipment and reference material to carry out the tasks assigned to them; (c) to have the necessary knowledge of international standards and best practices; (d) to have an appropriate administrative organisation and structure; (e) to ensure that their staff observe the confidentiality of the information and data obtained in carrying out their tasks. 4. EU reference laboratories may be granted a Union financial contribution. The Commission may adopt, by means of implementing acts, the modalities and the amount of the grant of a Union financial contribution to EU reference laboratories, taking into account the objectives of protection of health and safety, support of innovation and cost-effectiveness. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3). 5. Where notified bodies or Member States request scientific or technical assistance or a scientific opinion from an EU reference laboratory, they may be required to pay fees to wholly or partially cover the costs incurred by that laboratory in carrying out the requested task according to a set of predetermined and transparent terms and conditions. 6. The Commission shall specify be empowered to by means of adopt delegated implementing acts in accordance with Article 889 for the following purposes: (a) amending, or supplementing detailed rules to facilitate the application the tasks of EU reference laboratories referred to in of paragraphs 2 and details to ensure compliance with the criteria to be satisfied by EU reference laboratories referred to in paragraph 3; (b) setting out the structure and the level of the fees referred to in paragraph 5 which may be levied by an EU Reference Laboratory for providing scientific opinions in response to consultations by notified bodies and Member States in accordance with this Regulation, taking into account the objectives of protection of human health and safety, support of innovation and cost-effectiveness. 7315/14 LES/ns 8 ANNEX LIMITE EN 7. EU reference laboratories shall be subject to controls, including on-site visits and audits, by the Commission to verify compliance with the requirements of this Regulation. If these controls find that a laboratory is not complying with those requirements for which they have been designated, the Commission, by means of implementing acts, shall take appropriate measures, including the restriction, suspension or withdrawal of the designation. Article 82 Conflict of interests 1. Members of the MDCG, its sub-groups, DPs and staff of the EU reference laboratories shall not have financial or other interests in the medical device industry which could affect their impartiality. They shall undertake to act in the public interest and in an independent manner. They shall declare any direct and indirect interests they may have in the medical device industry and update this declaration whenever a relevant change occurs. Upon request, the declaration of interests shall be accessible to the public. This Article shall not apply to the representatives of stakeholder organisations participating in the sub-groups of the MDCG. 2. Experts and other third parties invited by the MDCG on a case-by-case basis shall be requested to declare their interests in the issue in question. Article 83 Device registers The Commission and the Member States shall take all appropriate measures to encourage the establishment of registers for specific types of devices to gather post-market experience related to the use of such devices. Such registers shall contribute to the independent evaluation of the long- term safety and performance of devices. ________________________ NOTE

P U BLI C Conseil UE 6908/14 PM/ns 1 DG B 4B LIMITE EN COUNCIL OF THE EUROPEAN UNION Brussels, 27 February 2014 Interinstitutional File: 2012/0266 (COD) 2012/0267 (COD) 6908/14 LIMITE PHARM 21 SAN 96 MI 210 COMPET 137 CODEC 556 NOTE from: Presidency to: Working Party on Pharmaceuticals and Medical Devices No. Cion prop.: 14493/12 PHARM 71 SAN 215 MI 597 COMPET 600 CODEC 2305 + COR 1 14499/12 PHARM 72 SAN 216 MI 598 COMPET 599 CODEC 2312 + COR 1 Subject: Proposal for a Regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices – Presidency proposal for Chapter V Delegations will find in the Annex a Presidency draft text for Chapter V of the proposal on medical devices, submitted for their agreement. The changes proposed to the Commission proposal should also be applicable to the corresponding articles of the proposal on in vitro medical devices. Text Conventions: Additions to the Commission proposals are indicated in bold italics. Deletions to the Commission proposal are indicated with strikethrough. ________________________ 6908/14 PM/ns 2 ANNEX DG B 4B LIMITE EN ANNEX Proposal on medical devices Chapter V Classification and conformity assessment Section 1 – Classification Article 41 Classification of medical devices 1. Devices shall be divided into classes I, IIa, IIb and III, taking into account their intended purpose and inherent risks. Classification shall be carried out in accordance with the classification criteria set out in Annex VII. 2. Any dispute between the manufacturer and the notified body concerned, arising from the application of the classification criteria, shall be referred for a decision to the competent authority of the Member State where the manufacturer has his registered place of business. In cases where the manufacturer has no registered place of business in the Union and has not yet designated an authorised representative, the matter shall be referred to the competent authority of the Member State where the authorised representative referred to in the last indent of point (b) of Section 3.2. of Annex VIII has his registered place of business. At least 14 days prior to any decision, The competent authority shall notify the MDCG and the Commission of its envisaged decision. 3. The Commission may, a At the request of a Member State or on its own initiative, by means of implementing acts, decide and after consulting the MDCG, the Commission may decide, by means of implementing acts, on the following: a) application of the classification criteria set out in Annex VII to a given device, or category or group of devices, with a view to determining their classification. b) that a device, or category or group of devices, should, by way of derogation from the classification criteria set out in Annex VII, be classified in another class; Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3). 6908/14 PM/ns 3 ANNEX DG B 4B LIMITE EN 4. In the light of technical and scientific progress and any information which becomes available in the course of the vigilance and market surveillance activities described in Articles 61 to 75, the Commission shall be empowered to adopt delegated acts in accordance with Article 89 as regards the following: a) deciding, that a device, or category or group of devices, should, by way of derogation from the classification criteria set out in Annex VII, be classified in another class; b) amending or supplementing updating the classification criteria set out in Annex VII. Section 2 – Conformity assessment Article 42 Conformity assessment procedures 1. Prior to placing a device on the market or its putting into service, manufacturers shall undertake an assessment of the conformity of that device. The conformity assessment procedures are set out in Annexes VIII to XI. 2. Manufacturers of devices classified as class III, other than custom-made or investigational devices, shall be subject to a conformity assessment based on full quality assurance and design dossier examination as specified in Annex VIII. Alternatively, the manufacturer may choose to apply a conformity assessment based on type examination as specified in Annex IX coupled with a conformity assessment based on product conformity verification as specified in Annex X. In the case of devices referred to in the first subparagraph of Article 1(4), the notified body shall follow the consultation procedure as specified in Section 6.1 of Chapter II of Annex VIII or Section 6 of Annex IX, as applicable. In the case of devices that are covered by this Regulation in accordance with point (e) of Article 1(2), the notified body shall follow the consultation procedure as specified in Section 6.2 of Chapter II of Annex VIII or Section 6 of Annex IX, as applicable. 6908/14 PM/ns 4 ANNEX DG B 4B LIMITE EN 3. Manufacturers of devices classified as class IIb, other than custom-made or investigational devices, shall be subject to a conformity assessment based on full quality assurance as specified in Annex VIII, except for its Chapter II, with assessment of the design documentation within the technical documentation on a representative basis. By way of derogation, the design dossier examination as specified in Chapter II of Annex VIII shall be applicable for Class IIb implantable devices. Alternatively, the manufacturer may choose to apply a conformity assessment based on type examination as specified in Annex IX coupled with a conformity assessment based on product conformity verification as specified in Annex X. 4. Manufacturers of devices classified as class IIa, other than custom-made or investigational devices, shall be subject to a conformity assessment based on full quality assurance as specified in Annex VIII, except for its Chapter II, with assessment of the design documentation within the technical documentation on a representative basis. Alternatively, the manufacturer may choose to draw up the technical documentation set out in Annex II coupled with a conformity assessment based on product conformity verification as specified in Section 7 of Part A or Section 8 of Part B of Annex X. 5. Manufacturers of devices classified as class I, other than custom-made or investigational devices, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 17 after drawing up the technical documentation set out in Annex II. If the devices are placed on the market in sterile condition or have a measuring function, the manufacturer shall apply the procedures set out in Annex VIII, except for its Chapter II, or in Part A of Annex X. However, the involvement of the notified body shall be limited: a) in the case of devices placed on the market in sterile condition, to the aspects of manufacture concerned with securing and maintaining sterile conditions, b) in the case of devices with a measuring function, to the aspects of manufacture concerned with the conformity of the devices with the metrological requirements. 6908/14 PM/ns 5 ANNEX DG B 4B LIMITE EN 6. Manufacturers may choose to apply a conformity assessment procedure applicable to devices of a higher class than the device in question. 7. Manufacturers of custom-made, other than implantable devices shall follow the procedure set out in Annex XI and draw up the statement set out in that Annex before placing the device on the market. Manufacturers of custom-made implantable devices shall be subject to the conformity assessment procedure based on full quality assurance as specified in Annex VIII, except for its Chapter II, with assessment of the design documentation within the technical documentation on a representative basis. 7a Furthermore, for devices intended for use by lay users, the manufacturer shall comply with the requirements laid down in Section 2 of Annex IX 8. The Member State in which the notified body is established may determine that all or certain documents, including the technical documentation, audit, assessment and inspection reports, relating to the procedures referred to in paragraphs 1 to 6 shall be available in an official Union language. Otherwise they shall be available in an official Union language acceptable to the notified body. 9. Investigational devices shall be subject to the requirements set out in Articles 50 to 60. 10. The Commission may, by means of implementing acts, specify the modalities and the procedural aspects with a view to ensuring harmonised application of the conformity assessment procedures by the notified bodies for any of the following aspects: – the frequency and the sampling basis of the assessment of the design documentation within the technical documentation on a representative basis as set out in Sections 3.3(c) and 4.5 of Annex VIII in the case of devices of classes IIa and IIb, and in Section 7.2 of Part A of Annex X in the case of devices of class IIa; 6908/14 PM/ns 6 ANNEX DG B 4B LIMITE EN – the minimum frequency of unannounced factory inspections and sample checks to be conducted by notified bodies in accordance with Section 4.4 of Annex VIII, taking into account the risk-class and the type of device; – the physical, laboratory or other tests to be carried out by notified bodies in the context of sample checks, design dossier examination and type examination in accordance with Sections 4.4 and 5.3 of Annex VIII, Section 3 of Annex IX and Section 5 of Part B of Annex X. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3). 11. In the light of technical and scientific progress and any information which becomes available in the course of the designation or monitoring of notified bodies set out in Articles 28 to 40, or of the vigilance and market surveillance activities described in Articles 61 to 75, the Commission shall be empowered to adopt delegated acts in accordance with Article 89 amending or supplement updating the conformity assessment procedures set out in Annexes VIII to XI. Article 43 Involvement of notified bodies 1. Where the conformity assessment procedure requires the involvement of a notified body, the manufacturer may apply to a notified body of his choice, provided that the body is notified for the conformity assessment activities, the conformity assessment procedures and the devices concerned. An application may not be lodged in parallel with more thanother one notified body for the same conformity assessment activity. 2. The notified body concerned shall inform the other notified bodies notified for the conformity assessment activities, the conformity assessment procedures and the devices concerned of any manufacturer who withdraws his application prior to the notified body's decision regarding the conformity assessment. Manufacturers shall also declare whether they have withdrawn an application with another notified body prior to the decision of that notified body. 6908/14 PM/ns 7 ANNEX DG B 4B LIMITE EN 3. The notified body may require any information or data from the manufacturer which is necessary in order to properly conduct the chosen conformity assessment procedure. 4. Notified bodies and the personnel of notified bodies shall carry out their conformity assessment activities with the highest degree of professional integrity and the requisite technical and scientific competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment activities, especially as regards persons or groups with an interest in the results of those activities. Article 44 Notification prior to placing on the market 1. Notified bodies shall inform the Commission of applications for conformity assessments for devices classified as class III, except applications to supplement or renew existing certificates. The notification shall be accompanied by the draft instructions for use referred to in Section 19.3 of Annex I and the draft summary of safety and clinical performance referred to in Article 26. In its notification, the notified body shall indicate the estimated date by which the conformity assessment is expected to be completed. The Commission shall immediately transmit the notification and the accompanying documents to the MDCG. 2. The Commission shall be empowered to adopt implementing acts in accordance with Article 88(3) to extend the scope of devices which should be notified before placing on market as referred to in Article 44 (1). 6908/14 PM/ns 8 ANNEX DG B 4B LIMITE EN Article 44a Opinion prior to issuing a certificate 1. Subject to the following sub-paragraph, the opinion of the MDCG shall be consulted prior to issuing the conformity assessment certificate for the following devices: - Implantable or active therapeutic devices intended to be used in direct contact with the heart, the central circulatory system or the central nervous system; - Spinal disc replacement implants, implantable devices that come into contact with the spinal column and hip, knee or shoulder total and partial joint replacements, except ancillary components ; - Aesthetic implantable or invasive devices. The MDCG need not be consulted prior to granting the conformity assessment certificate opinion for the devices referred to in the previous sub-paragraph for which common specifications referred to in Article 7 have been adopted for the clinical evaluation and the post-market clinical follow-up. 2. Upon receipt of an application for conformity assessment concerning a device mentioned in paragraph 1, the notified body shall transmit to the Commission the following documents: (a) The clinical evaluation report as referred to in Annex XIII(A), including the results of clinical investigations as referred to in Annex XIV; (b) The post market clinical follow-up plan referred to in Annex XIII (B); (c) The draft summary of safety and clinical performance referred to in Article 26; (d) The draft instructions for use referred to in Section 19.3; (e) The estimated date by which the conformity assessment is due to be completed by the notified body; The Commission shall immediately transmit these documents to the MDCG. 6908/14 PM/ns 9 ANNEX DG B 4B LIMITE EN 3. As soon as available, the notified body shall transmit a summary of the preliminary conformity assessment prior to issuing a certificate to the Commission for submission to the MDCG. The MDCG shall have a period of 30 days from receipt of may submit comments on the summary of the preliminary conformity assessment at the latest 60 days after submission of this summary., within which to give its opinion. Within this period of 30 days that period and at the latest 30 days after submission, the MDCG may request the submission of additional information that for on scientifically valid grounds, to analyse are necessary for the analysis of the notified body's preliminary conformity assessment. This may include a request for samples or an on-site visit to the manufacturer's premises. Until submission of the additional information requested, the period for delivering its opinion comments referred to in the first sentence of this subparagraph shall be suspended. Subsequent requests for additional information from the MDCG shall not suspend the period for the submission of comments delivering its opinion. 4. The MDCG opinion may rely on an assessment by an experts’ panel referred to in Article 78. 5. The notified body shall issue the certificate only after a positive opinion from the MDCG has been given. A positive opinion from the MDCG may be subject to modifications of the instructions for use, of the summary of safety and clinical performance or of the post-market clinical follow-up plan, or to communication to the MDCG of the summary of post-market clinical data. In case of negative opinion, the notified body shall not deliver the certificate. The notified body shall endeavour to take the utmost account of the opinion of the MDCG. If the MDCG has not delivered an opinion within the period laid down in paragraph 3, the opinion shall be considered to be positive. 6908/14 PM/ns 10 ANNEX DG B 4B LIMITE EN 6. The Commission shall make a summary of the comments submitted in accordance with paragraph 3 and the outcome of the conformity assessment procedure accessible to the public. The Commission shall publish MDCG opinions given in accordance with paragraph 3 by means of the electronic system referred to in Article 45. It shall not disclose any personal data or information of commercially confidential nature. 7. The Commission shall set up the technical infrastructure for the data-exchange by electronic means between notified bodies and the MDCG for the purposes of this Article. 8. The Commission, by means of implementing acts, may adopt the modalities and the procedural aspects concerning the submission and analysis of the summary of the preliminary conformity assessment in accordance with paragraphs 3 and 4. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3). 9. Where deemed necessary for the protection of patient safety and public health, the The Commission may determine, by means of implementing acts, specific categories or groups of devices other than devices referred to in paragraph 1 to which the procedure referred to in paragraphs 2 to 7 other than devices of class III, to which paragraphs 1 to 4 shall apply during a predefined period of time. These implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3). Measures taken pursuant to this paragraph shall may be justified only by one or more of the following criteria: (a) technological novelty or new medical purpose, which can have a significant clinical or public health impact the novelty of the device or of the technology on which it is based and the significant clinical or public health impact thereof; (b) adverse change in the risk-benefit profile of a specific category or group of devices; (c) increased rate of serious incidents reported in accordance with Article 61 regarding a specific category or group of devices; (d) significant discrepancies in the conformity assessments carried out by different notified bodies on substantially similar devices; (e) public health concerns regarding a specific category or group of devices or the technology on which they are based. 6908/14 PM/ns 11 ANNEX DG B 4B LIMITE EN Article 45 Certificates 1. The certificates issued by the notified bodies in accordance with Annexes VIII, IX and X shall be in an official Union language determined by the Member State in which the notified body is established or otherwise in an official Union language acceptable to the notified body. The minimum content of the certificates is set out in Annex XII. 2. The certificates shall be valid for the period they indicate, which shall not exceed five years. On application by the manufacturer, the validity of the certificate may be extended for further periods, each not exceeding five years, based on a re-assessment in accordance with the applicable conformity assessment procedures. Any supplement to a certificate shall remain valid as long as the certificate which it supplements is valid. 3. Where a notified body finds that requirements of this Regulation are no longer met by the manufacturer, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or impose any restrictions on it unless compliance with such requirements is ensured by appropriate corrective action taken by the manufacturer within an appropriate deadline set by the notified body. The notified body shall give the reasons for its decision. 4. The Commission, in collaboration with the Member States, shall set up and manage an electronic system to collate and process information on certificates issued by notified bodies. The notified body shall enter into this electronic system information regarding certificates issued, including amendments and supplements, and regarding suspended, reinstated, withdrawn or refused certificates and restrictions imposed on certificates. This information shall be accessible to the public. 5. In the light of technical progress, the Commission shall be empowered to adopt delegated acts in accordance with Article 89 amending or supplementing the minimum content of the certificates set out in Annex XII. 6908/14 PM/ns 12 ANNEX DG B 4B LIMITE EN Article 46 Voluntary change of notified body 1. In cases where a manufacturer terminates his contract with a notified body and enters into a contract with another notified body in respect of the conformity assessment of the same device, the modalities of the change of notified body shall be clearly defined in an agreement between the manufacturer, the outgoing notified body and the incoming notified body. This agreement shall address at least the following aspects: a) the date of invalidity of certificates issued by the outgoing notified body; b) the date until which the identification number of the outgoing notified body may be indicated in the information supplied by the manufacturer, including any promotional material; c) the transfer of documents, including confidentiality aspects and property rights; ca) the date of transfer after which products would be assigned to the new notified body. d) the date as of which the incoming notified body assumes full responsibility for the conformity assessment tasks. 2. On their date of invalidity, the outgoing notified body shall withdraw the certificates it has issued for the device concerned. Article 47 Derogation from the conformity assessment procedures 1. By way of derogation from Article 42, any competent authority may authorise, on duly justified request, the placing on the market or putting into service within the territory of the Member State concerned, of a specific device for which the procedures referred to in Article 42 have not been carried out and use of which is in the interest of public health or patient safety health if the effectiveness and safety of that device can be presumed according to the current state of scientific knowledge. 6908/14 PM/ns 13 ANNEX DG B 4B LIMITE EN 2. The Member State shall inform the Commission and the other Member States of any decision to authorise the placing on the market or putting into service of a device in accordance with paragraph 1 where such authorisation is granted for use other than for a single patient. 3. Upon request by a Member State and where this is in the interest of public health or patient safety health if the effectiveness and safety of that device can be presumed according to the current state of scientific knowledge in more than one Member State, the Commission may, by means of implementing acts, extend for a determined period of time the validity of an authorisation granted by a Member State in accordance with paragraph 1 to the territory of the Union and set the conditions under which the device may be placed on the market or put into service. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3). On duly justified imperative grounds of urgency relating to the health and safety of humans, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 88(4). Article 48 Certificate of free sale 1. For the purpose of export and upon request by a manufacturer, the competent authority of the Member State in which the manufacturer has its registered place of business shall issue a certificate of free sale declaring that the manufacturer is properly established and that the device in question bearing the CE-marking in accordance with this Regulation may be legally marketed in the Union. The certificate of free sale shall be valid for the period indicated on it which shall not exceed five years and shall not exceed the validity of the certificate referred to in Article 45 issued for the device in question. 2. The Commission may, by means of implementing acts, establish a model for certificates of free sale taking into account international practice as regards the use of certificates of free sale. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 88(2). ________________________ NOTE

P U BLI C Conseil UE 6804/14 PM/ns 1 DGB 4B LIMITE EN COUNCIL OF THE EUROPEAN UNION Brussels, 21 February 2014 (OR. en) Interinstitutional Files: 2012/0266 (COD) 2012/0267 (COD) 6804/14 LIMITE PHARM 19 SAN 91 MI 200 COMPET 130 CODEC 517 NOTE From: General Secretariat of the Council To: Working Party on Pharmaceuticals and Medical Devices No. prev. doc.: 5095/14 PHARM 4 SAN 5 MI 8 COMPET 9 CODEC 22 No. Cion doc.: 14493/12 PHARM 71 SAN 215 MI 597 COMPET 600 CODEC 2305 + COR 1 14499/12 PHARM 72 SAN 216 MI 598 COMPET 599 CODEC 2312 + COR 1 Subject: Proposal for a Regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices - Chapters VII, IX and X 1. On 16 December 2013 and 9 January 2014, the Working Party on Pharmaceuticals and Medical Devices concluded its first read-through of Chapters VII, IX and X of the above mentioned proposals. 2. In the context of the discussion on Chapters VII, "Vigilance and market surveillance", delegations noted that the definitions in Article 2 should be reconsidered, in particular, the definition of "incident" (including the concept of "use error") and "serious incident". 6804/14 PM/ns 2 DGB 4B LIMITE EN FR suggested deleting the word "unexpected" from the definitions of "incident". Some delegations further mentioned the need for a greater coherence between the definitions for "vigilance reporting" and "reporting during clinical investigations". DE suggested inserting the following changes in the proposal for a Regulation on Medical Devices: a) adding the following definition of "serious public health treat", currently in MEDDEV 2.12/1: "(44a) 'serious public health treat' means any event which results in imminent risk of death, serious deterioration in state of health, or serious illness that requires prompt remedial action."; b) adding a sentence to the definitions of "'corrective action'": "this includes product design modifications as well as modifications concerning the production process or technique;"; c) modifying the definition of "market surveillance": ‘market surveillance’ means the activities carried out and measures taken by public authorities to check and to ensure that products devices comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection; d) adding new definitions on "vigilance": "‘vigilance’ means activities carried out by public authorities to collect systematically information on risks of devices available on the EU market, to assess these information and the underlying risks and measures taken to ensure that devices do not endanger health, safety or any other aspect of public health;". 2. Probably to be considered in the context of Chapters IX (Confidentiality), BE/PT/IE suggested that, in order to avoid duplication of communication systems, it should be envisaged to restrict the visibility of some information contained in the unique electronic system to the Member States and the Commission. 6804/14 PM/ns 3 DGB 4B LIMITE EN 3. Concerning the electronic system referred to in Article 62, the NL delegation pointed up that it will contain a considerable amount of vigilance data and that, consequently, the responsibilities for these data and for the overall analysis of the data should be clearly defined. The Commission clarified that the Commission's Joint Research Centre should assume the responsibility. 4. The result of the referred examination is set out in Annexes A and B of this document. More specific comments of the delegations can be found in the footnotes1. 5. All delegations have welcomed the proposals but entered, at this stage, general scrutiny reservations. The Danish and United Kingdom delegations have entered parliamentary scrutiny reservations. ________________________ 1 The delegations' comments made with reference to the proposal for a Regulation on medical devices should also be considered applicable to the identical parts of the text of the proposal for a Regulation on in vitro diagnostic medical devices. 6804/14 PM/ns 4 DGB 4B LIMITE EN ANNEX A Chapter VII2 Vigilance and market surveillance SECTION 1 – VIGILANCE Article 60a Register of incidents 1. Manufacturers of devices, other than investigational devices, shall register all incidents reported by other economic operators, patients or users, health care professionals or identified in the context of a post-market clinical investigation referred to in Article 59(5). 2. Manufacturers shall keep updated a synthesis of the incidents referred to in paragraph 1, including the number and frequency of occurrence of each type of incident. Upon request, the synthesis shall be made available to the notified body that issued the certificate in accordance to Article 45 and to the competent authorities of the Member States. Article 613 Reporting of serious incidents and field safety corrective actions 1. Manufacturers of devices shall report in respect of the devices they made available, other than custom-made or investigational devices, through the electronic system referred to in Article 62, the following: (a) any serious incident, wherever it happens; (b) any field safety corrective action4 in respect of devices made available on the Union market, including any field safety corrective action undertaken in a third country in relation to a device which is also legally made available on the Union market wherever it is undertaken, if the reason for the field safety corrective action is not limited to circumstances related to the device made available in the a third country. 2 CZ: scrutiny reservation on this Chapter. 3 As a general remark, DE/HU noted that compared to the current reporting system (Article 10 of Directive 93/42/EEC), which could be improved, this totally different approach is too complex and bureaucratic. HU/DK: scrutiny reservation. 4 BE: which can be taken to eliminate the cause of a potential or real non-conformity or other undesirable situation related to potential incidents. 6804/14 PM/ns 5 DGB 4B LIMITE EN 1a. Manufacturers shall make the report the incident referred to in the first subparagraph without delay, [through the electronic system referred to in Article 62], as soon as they have become aware of the incident or they have adopted5 the field safety corrective actions, and no later than: (a) 2 days in the case of serious public health treat; (b) 7 days in the case of serious incidents. after they have become aware of the event and the causal relationship with their device or that such causal relationship is reasonably possible. The time period for reporting shall take account of the severity of the incident. 1b. Manufacturers shall provide an initial report on serious incidents in accordance with paragraph 1 or an explanatory statement why the incident does not fulfil the definition of a serious incident to the competent authorities of the Member States have been made available. If the competent authority does not agree with the explanatory statement, it can request a report in accordance with paragraph 1. 1c. Where necessary to ensure timely reporting, the manufacturer may submit an initial incomplete report followed up by a complete report, no later than […] days6 after the incident or the adoption of the field safety corrective action. 2. For similar serious incidents occurring with the same device or device type and for which the root cause has been identified or the field safety corrective action implemented, manufacturers may provide periodic summary reports instead of individual incident reports, on condition that the competent authorities referred to in points (a), (b) and (c) of Article 62(5)7 and, where applicable, the coordinating competent authority referred to in Article 63(6), have agreed with the manufacturer on the format, content and frequency of the periodic summary reporting. 5 UK/PT/AT: consider that the competent authority should be informed of the corrective action before it is adopted. DE consider that they have to be reported at the latest by the time of implementation. 6 BE: proposed 3 months. FR proposed 1 month. 7 DE/ES: the competent authorities must be clearly defined. 6804/14 PM/ns 6 DGB 4B LIMITE EN 3. 8The Member States shall take all appropriate measures to encourage healthcare professionals, users and patients to report to their competent authorities suspected serious incidents referred to in point (a) of paragraph 1. They shall record such reports centrally at national level. Where a competent authority of a Member State obtains such reports, it shall take the necessary steps to ensure that the manufacturer of the device concerned, or his authorised representative, is informed of the serious incident [through the electronic system referred to in Article 62]. 3a. The manufacturer shall ensure the appropriate follow-up. 3b. The Member States MDGC shall coordinate between them with the Commission the development of standard web-based structured forms a minimum data set for electronic reporting of serious incidents by healthcare professionals, users and patients. [3c. The Commission shall ensure that the electronic system referred to in Article 62 allows direct reporting from Member States’ databases of any reports received pursuant to this paragraph.] 4. Manufacturers of custom-made devices shall report any serious incidents and field safety corrective actions referred to in paragraph 1 to the competent authority of the Member State in which the device in question has been made available. 8 HU: see EP amendments for 62(3). 6804/14 PM/ns 7 DGB 4B LIMITE EN Article 62 Electronic system on vigilance 1. The Commission shall, in collaboration with the Member States, set up and manage an electronic system to collate and process the following information by means of the electronic system referred to in point (e) of Article 27(1). (a) the initial and final reports by manufacturers on serious incidents and field safety corrective actions referred to in Article 61(1); (b) the periodic summary reports by manufacturers referred to in Article 61(2); (c) the reports by competent authorities on serious incidents referred to in the second subparagraph of Article 63(1); (d) the reports by manufacturers on trends referred to in Article 64; (da) the periodic safety update reports referred to in Article 65a; (e) the field safety notices by manufacturers referred to in Article 63(5); (f) the information to be exchanged between the competent authorities of the Member States and between them and the Commission in accordance with Article 63(4) and (7). 2. The information collated and processed by the electronic system shall be accessible to the competent authorities of the Member States, to the Commission and to the notified bodies. 3. The Commission shall ensure that healthcare professionals and the public have appropriate levels of access to the electronic system9. 4. On the basis of arrangements between the Commission and competent authorities of third countries or international organisations, the Commission may grant those competent authorities or international organisations access to the database at the appropriate level. Those arrangements shall be based on reciprocity and make provision for confidentiality and data protection equivalent to those applicable in the Union. 9 HU: levels of access should be established here. 6804/14 PM/ns 8 DGB 4B LIMITE EN 5. The reports on serious incidents and field safety corrective actions referred to in points (a) and (b) of Article 61(1), the periodic summary reports referred to in Article 61(2), the reports on serious incidents referred to in the second subparagraph of Article 63(1) and the trend reports referred to in Article 64 to (e) of paragraph 1 shall be automatically transmitted, upon receipt, via through the electronic system referred to in Article 62, to the competent authorities of the following Member States: (a) the Member State where the incident occurred; (b) the Member State where the field safety corrective action is being or is to be undertaken; (c) the Member State where the manufacturer has his registered place of business; (d) where applicable, the Member State where the notified body, that issued a certificate in accordance with Article 45 for the device in question, is established. 5a. Where applicable, the information referred to in paragraph 5 shall be automatically transmitted, upon receipt, through the electronic system referred to in Article 62, to the notified body that issued the certificate to the concerned device in accordance with Article 45. 10 10 SE: adding: "6. Nothing in this Article shall cause prejudice to the national laws and regulations regarding public access to documents." 6804/14 PM/ns 9 DGB 4B LIMITE EN Article 63 Analysis of serious incidents and field safety corrective actions 1. The Member States shall take adopt the necessary steps measures to ensure that any information regarding a serious incident that has occurred within their territory or a field safety corrective action that has been or is to be undertaken within their territory, and that is brought to their knowledge in accordance with Article 61 is, at national level, evaluated centrally by their competent authority11, if possible together with the manufacturer and, where applicable, his authorised representative. If, in the case of reports received in accordance with Article 61(3), the competent authority ascertains that the reports relate to a serious incident, it shall notify without delay those reports to the electronic system referred to in Article 62, unless the same incident has already been reported by the manufacturer. 1a. Manufacturers shall perform appropriate investigations of the reported serious incident and the involved devices, monitored by the competent authorities referred to in points (a), (b) and (c) of Article 62(5). However, manufacturers shall consult the competent authority before performing any investigation which involves altering the device or a sample of the batch concerned in a way which may affect any subsequent evaluation of the causes of the incident. Manufacturers shall provide a final report about their findings, conclusions and if necessary corrective actions through the electronic system referred to in Article 62. 1b. Manufacturers shall undertake the field safety corrective actions necessary to minimise or eliminate risks, in accordance to the general safety and performance requirements established in this Regulation. [When placing the devices on the market, manufacturers shall adopt precautionary measures to ensure that any necessary field safety corrective action applicable to a device which could represent a serious risk will be performed as quickly and reliably as possible.] 11 NL: When incidents have occurred in more than one Member State, how will it be coordinated until the coordinating competent authority is appointed? 6804/14 PM/ns 10 DGB 4B LIMITE EN 2. The national competent authorities shall carry out a risk assessment12 with regard to reported serious incidents or field safety corrective actions, taking into account criteria such as causality, detectability and probability of recurrence of the problem, frequency of use of the device, probability of occurrence of direct or indirect harm and severity of that harm, clinical benefit of the device, intended and potential users, and population affected. They shall also evaluate the adequacy of the field safety corrective action envisaged or undertaken by the manufacturer and the need for and kind of any other corrective action. They shall monitor the manufacturer’s investigation of the serious incident. 3. In the case of devices referred to in the first subparagraph of Article 1(4) and where the serious incident or field safety corrective action may be related to a substance which, if used separately, would be considered to be a medicinal product, the evaluating competent authority or the coordinating competent authority referred to in paragraph 6 shall inform the relevant competent authority for medicinal products, or the European Medicines Agency (EMA), that was consulted by the notified body in accordance with the second subparagraph of Article 42(2). In the case of devices covered by this Regulation in accordance with point (e) of Article 1(2) and where the serious incident or field safety corrective action may be related to the tissues or cells of human origin utilised for the manufacture of the device, the competent authority or the coordinating competent authority referred to in paragraph 6 shall inform the relevant competent authority for human tissues and cells that was consulted by the notified body in accordance with the third subparagraph of Article 42(2). 12 NL: the problem is that, according to 61(1), manufacturers may submit an incomplete report. How can the competent authorities ensure the thoroughness of the assessment if they do not obtain all the relevant information on the device? 6804/14 PM/ns 11 DGB 4B LIMITE EN 4. After carrying out the assessment, the evaluating competent authority shall, through the electronic system referred to in Article 62, inform without delay the other competent authorities of the corrective action taken or envisaged by the manufacturer or imposed on him to minimise the risk of recurrence of a serious incident or provide to the other competent authorities, to the notified body that issued the certificate in accordance with Article 45, the manufacturer and, where applicable, to the reporting users, a final report, including information on the underlying events and the outcome of its assessment. 5. The manufacturer shall ensure that the users of the device in question are informed without delay of the corrective action taken by means of a field safety notice in an official Union language which can be easily understood by the affected user or patient. Except in case of urgency13, the content of the draft field safety notice shall be submitted to the evaluating competent authority or, in cases referred to in paragraph 6 of this Article, the coordinating competent authority to allow them to make comments. Unless duly justified by the situation of the individual Member State, the content of the field safety notice shall be consistent in all Member States and in particular: a) identify the affected device, indicating the following elements: type of device, model name and number, batch/lot or serial numbers and part or order number, b) describe the deficiencies or malfunctions as well as, where identified, their causes; c) describe the devices' risks and the facts on which the risk assessment is based, d) clearly explain the potential hazard associated with the continued use of the device and the associated risk to the patient, user or other person e) clearly indicate the necessary corrective measures, f) indicate a contact person or a contact point for further questions; g) indicate any additional useful information. [Information able to play down the risks and advertising messages are not allowed.] The content of the field safety notice shall be made accessible to the public by the competent authority through the electronic system referred to in Article 62. The manufacturer shall enter the field safety notice in the electronic system referred to in Article 62 through which that notice shall be accessible to the public. 13 NL: who will define the cases of urgency? 6804/14 PM/ns 12 DGB 4B LIMITE EN 6. The competent authorities shall designate a coordinating competent authority to coordinate their assessments referred to in paragraph 2 in the following cases: (a) where similar serious incidents related to the same device or type of device of the same manufacturer occur in more than one Member State; (b) where the field safety corrective action is being or is to be undertaken in more than one Member State. 14Unless otherwise agreed between the competent authorities, the coordinating competent authority shall be the one of the Member State where the manufacturer or the authorised representative has his registered place of business. The coordinating competent authority shall inform [through the electronic system referred to in Article 62] the manufacturer, the other competent authorities and the Commission that it has assumed the role of coordinating authority 157. The coordinating competent authority shall carry out the following tasks: (a) to monitor the investigation of the serious incident by the manufacturer and the corrective action to be taken; (b) to consult with the notified body that issued a certificate in accordance with Article 45 for the device in question regarding the impact of the serious incident on the certificate; (c) to agree with the manufacturer and the other competent authorities referred to in points (a) to (c) of Article 62(5) on the format, content and frequency of periodic summary reports in accordance with Article 61(2); (d) to agree with the manufacturer and other competent authorities concerned on the implementation of the appropriate field safety corrective action; (e) to inform the other competent authorities and the Commission, through the electronic system referred to in Article 62, of the progress in and the outcome of its assessment. 14 DE/IE/AT: The competent authorities shall actively participate in a coordination procedure developed by the MDCG. This procedure should include the following: • the designation of a coordinating authority on a case by case basis • a definition of the coordinated assessment process, tasks and responsibilities of the coordinating and the other competent authorities in this process. 15 NL: how will the coordination be ensured when more than one competent authority has evaluated/assessed an incident and the coordinating authority is not yet appointed? 6804/14 PM/ns 13 DGB 4B LIMITE EN The designation of a coordinating competent authority shall not affect the rights of the other competent authorities to perform their own assessment and to adopt measures in accordance with this Regulation in order to ensure the protection of public health and patient safety. The coordinating competent authority and the Commission shall be kept informed of the outcome of any such assessment and the adoption of any such measures. 8. The Commission shall provide secretarial logistics support to the coordinating competent authority in the accomplishment of its tasks under this Chapter. Article 6416 Trend reporting Manufacturers of devices classified in class IIb and III17 shall report to the electronic system referred to in Article 62 any statistically significant increase in the frequency or severity of incidents that are not serious incidents or of expected undesirable side-effects that have a significant impact safety and performance of the device on the risk-benefit analysis referred to in Sections 1 and 5 of Annex I and which have led or may lead to unacceptable risks to the health or safety of patients, users or other persons when weighted against the intended benefits. The significant increase shall be established in comparison to the foreseeable frequency or severity of such incidents or expected undesirable side-effects in respect of the device, or category or group of devices, in question during a specific time period as established in the manufacturer’s post market performance follow-up plan conformity assessment. Article 63 shall apply. Article 65 Documentation of vigilance data Manufacturers shall update their technical documentation referred to in Annex II with: a) information on incidents received from competent authorities, healthcare professionals, patients, and users, and any other economic operator; 16 FR: scrutiny reservation; where is defined the "foreseeable frequency or severity of such incidents or expected undesirable side-effects in respect of the device"? 17 Cion: should be carefully considered in view of the important increase in the information flow it will generate. 6804/14 PM/ns 14 DGB 4B LIMITE EN b) reports on serious incidents, field safety corrective actions, and periodic summary reports referred to in Article 61, c) trend reports referred to in Article 64 and field safety notices referred to in Article 63(5). They shall make this documentation available to their notified bodies, which shall assess the impact of the vigilance data on the conformity assessment and the certificate issued. Article 65a18 Periodic safety update reports 18 FR alternative wording: Article 65a - Periodic safety update reports 1. Manufacturers of implantable devices and devices falling within class III shall transmit, by means of the electronic system referred to in Article 62, periodic safety update reports including: (a) summaries of data relevant to the benefits and risks of the medical devices, including results of all studies with a consideration of their potential impact on the certificate and the vigilance summary referred to in Article 61 (1); (b) a scientific evaluation of the risk-benefit ratio of the device; (c) all data relating to the volume of sales of the devices including an estimate of the population exposed to the device. Manufacturers shall submit safety update reports annually during the period of validity of the first certificate. In case of certificate renewal, these reports shall be transmitted every two years. 2. The MDCG may assess the safety update reports regarding devices which undergone the procedure laid down in Article 44 in order to determine whether there are new risks or whether risks have changed, or whether there are changes to the risk-benefit ratio of the medical device. 3. Following the assessment of the periodic safety update reports, the MDCG shall consider whether any action regarding the device concerned is necessary. The MDCG shall inform the notified body in case of unfavorable scientific assessment. In this case, the notified body shall maintain, amend, suspend or withdraw the certificate as appropriate. 4. The competent authorities may conduct their own assessment on the reports referred to in the first paragraph and to adopt measures in accordance with the present regulation in order to ensure the protection of public health and patient safety. The competent authority inform the Commission and the other competent authorities as well as the notified body that issued the certificate, of the results of such evaluation and of the adoption of such measures. 5. Where deemed necessary for the protection of public health, the Commission may after consultation of the MDCG, determine, by means of implementing acts, categories of devices, other than implantable devices and devices of class III, to which the present article shall apply during a predefined period of time. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 88(3). 6804/14 PM/ns 15 DGB 4B LIMITE EN 1. In the case of devices classified as class III and implantable devices, other than custom- made or investigational devices, manufacturers shall draw up a periodic safety update report, which shall include summary information on all reported incidents and other information relevant to the on-going conformity assessment of the device with the requirements in Annex I. This report shall be uploaded to the database referred to in Article 62, submitted to the notified body involved in the conformity assessment in accordance with Article 42 and used to update the summary of safety and clinical performance referred to in Article 26. 2. The Commission may, by means of implementing acts, set out the form and presentation of the information to be included in a periodic safety update report and the frequency by which relevant manufacturers must submit such a report. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3). Article 65b Analysis of vigilance data The Commission shall, in collaboration with the Member States, put in place systems and processes to proactively monitor the data available in the database referred to in Article 62, in order to identify trends, patterns or signals in the data that may identify new risks or safety concerns. When a risk is identified, Article 64b is applicable. 6804/14 PM/ns 16 DGB 4B LIMITE EN Article 65c19 Post-market surveillance by the manufacturer 1. The manufacturer of a device shall ensure compliance with the provisions of this Regulation throughout the entire lifetime of the devices while the devices he has is made available on the market. To this end, the manufacturer shall plan, continuously conduct and document post-market surveillance to gather data about the performance and safety of the device. 2. The manufacturer shall use and update the gathered data for at least the following purposes: a) to update the technical documentation as specified in Annex I, in particular as concerns: o i) the risk/benefit analysis and risk management; o ii) the design and manufacturing information; o iii) the instructions for use; b) to update the clinical evaluation; c) identification of needs for preventive, corrective or field safety corrective action; d) identification of possibilities to improve the usability, performance and safety of the device. 3. If in the course of the post-market surveillance a need for corrective action is identified, the manufacturer shall implement the appropriate measures and, where applicable, inform the notified body and the competent authorities concerned. The identification of an incident or a field safety corrective action shall induce actions according to article 61. 4. The manufacturer shall establish, document, implement, maintain and update a post- market surveillance plan which shall be part of the technical documentation as specified in Annex II. 19 In general, delegations could accept this proposal as far as it does not affect the pre-market surveillance provisions. 6804/14 PM/ns 17 DGB 4B LIMITE EN 5. The manufacturer shall prepare an annual report summarising the implications of analysis of the gathered post-market surveillance data, which shall be part of the technical documentation as specified in Annex II. Article 6620 Implementing acts The Commission may, by means of implementing acts, adopt the modalities and procedural aspects necessary for the implementation of Articles 61 to 65 as regards the following: (a) typology21 of serious incidents and field safety corrective actions in relation to specific devices, or categories or groups of devices; (b) harmonised forms for the reporting of serious incidents and field safety corrective actions, periodic summary reports and trend reports and periodic safety update reports by manufacturers as referred to in Articles 61 and 64; (c) timelines for the reporting of serious incidents and field safety corrective actions, periodic summary reports and trend reports by manufacturers, taking into account the severity of the event to be reported as referred to in Articles 61 and 6422; (d) harmonised forms for the exchange of information between competent authorities as referred to in Article 63. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3). 20 FR: scrutiny reservation. DE: reservation: the harmonised forms can be developed though the EUDAMED system. 21 SE: deleting this point or clarifying the meaning of "typology". 22 IT/CY/PT/IE: opposed; the timelines should be established in Article 61. 6804/14 PM/ns 18 DGB 4B LIMITE EN SECTION 2 – MARKET SURVEILLANCE Article 67 Market surveillance activities 231. The competent authorities for medical devices shall perform appropriate checks on the conformity characteristics and performance of the devices with the applicable requirements of this Regulation, including, where appropriate, review of technical documentation and physical or laboratory checks on the basis of adequate samples. They shall take account of a) established principles regarding risk assessment and risk management; b) vigilance data and c) complaints. 1a. The competent authorities may require e For the purposes of paragraph 1, a) economic operators shall to make available the documentation and information necessary for the purpose of carrying out their activities and, where necessary and justified, enter take provide the necessary samples of devices. b) the competent authorities shall carry out both announced and unannounced inspections of the premises of economic operators and health care professionals. 1b. The competent authorities They may destroy or otherwise render inoperable devices presenting a serious risk where they deem it necessary. 23 IE: activities could be described in more detail in an Annex, which could be amended by implementing measures (delegated acts)? 6804/14 PM/ns 19 DGB 4B LIMITE EN 2. The competent authorities Member States shall periodically review and assess the functioning of their surveillance activities. Such reviews and assessments shall be carried out at least every four24 years. and, The Member States shall communicate the results of the reviews and assessments thereof shall be communicated to the other Member States and the Commission and make The Member State concerned shall make a summary of the results accessible to the public a summary of the results, through the electronic system referred to in Article 68 2a. Taking into account the European market surveillance programme developed by the MDCG according to Article 80, the competent authorities shall draw up annual plans covering the planned surveillance activities as well as the human and material resources needed to carry out those activities. 253. Taking into account the European market surveillance programme developed by the MDCG according to Article 80, tThe competent authorities of the Member States shall coordinate their market surveillance activities, cooperate with each other and share with each other and with the Commission the results thereof, through the electronic system referred to in Article 68. Where appropriate, the competent authorities of the Member States shall agree on work- sharing, joint market surveillance activities and specialisation, for example in specific device technologies, processes or surveillance methods. 4. Where more than one authority in a Member State is responsible for market surveillance and external border controls, those authorities shall cooperate with each other, by sharing information relevant to their role and functions. 5. Where appropriate, tThe competent authorities of the Member States shall cooperate with the competent authorities of third countries with a view to exchanging information and technical support and promoting activities relating to market surveillance. 24 IE: 3 years, in line with the requirements for re-designation of notified bodies. 25 IE: what could be the role of the MDCG? 6804/14 PM/ns 20 DGB 4B LIMITE EN Article 68 Electronic system on market surveillance 1. The Commission, in collaboration with the Member States, shall set up and manage an electronic system to collate and process the following information through the electronic system referred to in point (f) of Article 27(1). (a) information in relation to non-compliant devices presenting a [serious] risk to health and safety referred to in Article 70(2), (4) and (6); (b) information in relation to compliant devices presenting a risk to health and safety referred to in Article 72(2); (c) information in relation to formal non-compliance of products referred to in Article 73(2); (d) information in relation to preventive health protection measures referred to in Article 74(2); (e) information of the results of the reviews and assessments of the surveillance of the activities of the Member States and information of the results of the cooperation referred to in Article 67(3). 2. The information mentioned in paragraph 1 shall be immediately transmitted through the electronic system to all competent authorities concerned and to the notified body that issued a certificate in accordance with Article 45 for the device concerned and be accessible to the Member States and to the Commission. Article 69 Evaluation regarding of devices presenting a possible risk to health and safety at national level Where the competent authorities of a Member State, based on vigilance data or other information, have sufficient reason to believe that a device [made available on the territory of their Member State] presents a risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health, they shall carry out an evaluation in relation to the device concerned covering all the requirements laid down in this Regulation that are relevant to the risk presented by the device. The relevant economic operators shall cooperate as necessary with the competent authorities. 6804/14 PM/ns 21 DGB 4B LIMITE EN Article 70 Procedure for dealing with non-compliant devices presenting a risk to health and safety 1. Where, having performed an evaluation pursuant to Article 69, the competent authorities find that the device, which presents a risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health, does not comply with the requirements laid down in this Regulation, they shall without delay require the relevant economic operator to take all appropriate and duly justified corrective action to bring the device into compliance with those requirements of this Regulation, to prohibit or restrict the making available of the device on the market, to subject the making available of the device to specific requirements, to withdraw the device from the market, or to recall it within a reasonable period, proportionate to the nature of the risk. 2. Where tThe competent authorities consider that non-compliance is not restricted to their national territory, they shall inform notify the Commission, and the other Member States and the notified body that issued a certificate in accordance with Article 45 for the device concerned of the results of the evaluation and of the actions which they have required the economic operators to take, by means of the electronic system referred to in Article 68. 3. The economic operators shall ensure that all appropriate corrective action is taken in respect of all the devices concerned that they have made available on the market throughout the Union. 4. Where the relevant economic operator does not take adequate corrective action within the period referred to in paragraph 1, the competent authorities shall take all appropriate provisional measures to prohibit or restrict the device’s being made available on their national market, to withdraw the device from that market or to recall it. They shall notify the Commission and the other Member States and the notified body that issued a certificate in accordance with Article 45 for the device concerned, without delay, of those measures, by means of the electronic system referred to in Article 68. 6804/14 PM/ns 22 DGB 4B LIMITE EN 5. The notification referred to in paragraph 4 shall include all available details, in particular the data necessary for the identification and traceability of the non-compliant device available by means of the electronic system referred to in Article 25, the origin of the device, the nature of and the reasons for the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. 6. Member States other than the Member State initiating the procedure shall, without delay, inform the Commission and the other Member States, through the electronic system referred to in Article 68, a) of any additional information at their disposal relating to the non-compliance of the device concerned and; b) of any measures adopted by them in relation to the device concerned. 6a In the event of disagreement of a Member State with the a notified national measure referred to in paragraph 4 or in point b) of paragraph 626, they the Member State shall without delay inform the Commission and the other Member States of their objections, by means of the electronic system referred to in Article 68.27 7. Where, within two months of receipt of the notification referred to in paragraph 4, no objection has been raised by either a Member State or the Commission in respect of a provisional measure taken by a Member State, that measure shall be deemed justified. 8. All Member States shall ensure that appropriate restrictive or prohibitive measures, withdrawing, recalling or limiting the availability of the device on their national market are taken without delay in respect of the device concerned. 26 The change introduced take into account NL remark in page 20 of DS 1003/14, according to which the Member state initiating the procedure should have the possibility to object to the national measures take by another Member State. 27 Cion: the possibility for any Member State to object to the measures taken by another Member State would be difficult to apply and should therefore be reconsidered. 6804/14 PM/ns 23 DGB 4B LIMITE EN Article 71 Procedure at Union level 1. Where, within two months of receipt of the notification referred to in Article 70(4) and point b) of 70(6), objections are raised by a Member State against a provisional measure taken by another Member State, or where the Commission considers the measure to be contrary to Union legislation, the Commission shall, after consulting the MDCG and, where appropriate, the interest economic operators, evaluate the national measure. On the basis of the results of that evaluation, the Commission shall decide, by means of implementing acts, whether or not the national measure is justified. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3). 2. If the national measure is considered justified, Article 70(8) shall apply. If the national measure is considered unjustified, the Member State concerned shall withdraw the measure. 2a. Where, in the situations referred to in Articles 70 and 72, a Member State or the Commission consider that the risk to health and safety emanating from a device cannot be contained satisfactorily by means of measures taken by the Member State(s) concerned, the Commission, at the request of a Member State or on its own initiative, may take, by means of implementing acts, the necessary and duly justified measures to ensure the protection of health and safety, including measures restricting or prohibiting the placing on the market and putting into service of the device concerned. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).28 3. On duly justified imperative grounds of urgency relating to the health and safety of humans, the Commission shall adopt immediately applicable implementing acts referred to in paragraphs 1 and 2a in accordance with the procedure referred to in Article 88(4). 28 FR/UK: reservations; consider that market surveillance measures should remain within the competence of the Member States (see Article R32 of Decision 768/2008). 6804/14 PM/ns 24 DGB 4B LIMITE EN Article 7229 Procedure for dealing with compliant devices presenting a risk to health and safety 1. Where, having performed an evaluation pursuant to Article 69, a Member State finds that although a device has been legally made available placed on the market or put into service, it presents a risk to the health or safety of patients, users or other persons or to other aspects of the protection of public health, it shall require the relevant economic operator or operators to take all appropriate provisional measures corrective actions to ensure that the device concerned, when placed on the market or put into service, no longer presents that risk, to withdraw the device from the market or to recall it within a reasonable period, proportionate to the nature of the risk. 2. The Member State shall immediately notify the Commission and the other Member States of the measures taken, by means of the electronic system referred to in Article 68. That information shall include the data necessary for the identification of the device concerned, the origin and the supply chain of the device, the findings of the Member State's evaluation specifying the nature of the risk involved and the nature and duration of the national measures taken. 2a. The economic operators shall ensure that all appropriate corrective action is taken in respect of all the devices concerned that they have made available on the market. 3. The Commission shall evaluate the provisional national measures taken. On the basis of the results of that evaluation, the Commission shall decide, by means of implementing acts, whether or not the measure is justified. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3). On duly justified imperative grounds of urgency relating to the health and safety of humans, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 88(4)30. 29 DE: questioned the need for this Article as any device which presents a risk should be considered non-compliant with this Regulation (cf. Article 4(1). 30 FR/UK: reservations; consider that market surveillance measures should remain within the competence of the Member States (see Article R32 of Decision 768/2008). 6804/14 PM/ns 25 DGB 4B LIMITE EN 4. Where the national measure is considered justified, Article 70(8) shall apply. If the national measure is considered unjustified, the Member State concerned shall withdraw the measure. Article 73 Formal non-compliance 1. Without prejudice to Article 70, a Member State shall require the relevant economic operator to put an end to the non-compliance concerned within a reasonable period that is proportionate to the non-compliance where it makes one of the following findings: (a) that the CE marking has been affixed in violation of the formal requirements laid down in Article 18; (b) that the CE marking has not been affixed to a device contrary to Article 18; (c) that the CE marking has been inappropriately affixed in accordance with procedures in this Regulation on a product that is not covered by this Regulation; (d) that the EU declaration of conformity has not been drawn up in conformity with this Regulation or is not complete; (e) that the information to be supplied by the manufacturer on the label or in the instructions for use is not available, not complete or not provided in the language(s) required in conformity with this Regulation; (f) that the technical documentation, including the clinical evaluation, is not available or not complete in conformity with this Regulation. 2. Where the economic operator does not put an end to the non-compliance within the period referred to in paragraph 1, the Member State concerned shall take all appropriate measures to restrict or prohibit the product being made available on the market or to ensure that it is recalled or withdrawn from the market. That Member State shall inform the Commission and the other Member States without delay of those measures, by means of the electronic system referred to in Article 68. 6804/14 PM/ns 26 DGB 4B LIMITE EN Article 74 Preventive health protection measures 1. Where a Member State, after having performed an evaluation which indicates a potential risk related to a device or a specific category or group of devices considers that the making available on the market or putting into service of such device or specific category or group of devices should be prohibited, restricted or made subject to particular requirements or that such device or category or group of devices should be withdrawn from the market or recalled in order to protect the health and safety of patients, users or other persons or other aspects of public health, it may take any necessary and justified provisional measures. 2. The Member State shall immediately notify the Commission and all other Member States, giving the reasons for its decision, by means of the electronic system referred to in Article 68. 3. The Commission, in consultation with the MDCG and, where appropriate, the concerned economic operators, shall assess the provisional national measures taken. The Commission shall decide, by means of implementing acts, whether the national measures are justified or not. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3). On duly justified imperative grounds of urgency relating to the health and safety of humans, the Commission may adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 88(4). 4. Where the assessment referred to in paragraph 3 demonstrates that the making available on the market or putting into service of a device, specific category or group of devices should be prohibited, restricted or made subject to particular requirements or that such device or category or group of devices should be withdrawn from the market or recalled in all Member States in order to protect the health and safety of patients, users or other persons or other aspects of public health, the Commission shall be empowered to adopt delegated acts in accordance with Article 89 to take the necessary and duly justified measures. Where in this case imperative grounds of urgency so require, the procedure provided for in Article 90 shall apply to delegated acts adopted pursuant to this paragraph. 6804/14 PM/ns 27 DGB 4B LIMITE EN Article 75 Good administrative practice 1. Any measure adopted by the competent authorities of the Member States pursuant to Articles 70 to 74 shall state the exact grounds on which it is based. Where it is addressed to a specific economic operator, it shall be notified without delay to the economic operator concerned, who shall at the same time be informed of the remedies available to him under the law of the Member State concerned and of the time limits to which such remedies are subject. Where the measure is of general scope, it shall be appropriately published. 2. Except in cases where immediate action is necessary for reasons of serious risk to human health or safety, the economic operator concerned shall be given the opportunity to make submissions to the competent authority within an appropriate period of time before any measure is adopted. If action has been taken without the economic operator’s being heard, he shall be given the opportunity to make submissions as soon as possible and the action taken shall be reviewed promptly thereafter. 3. Any measure adopted shall be immediately withdrawn or amended upon the economic operator’s demonstrating that he has taken effective corrective action. 4. Where a measure adopted pursuant to Articles 70 to 74 concerns a product for which a notified body has been involved in the conformity assessment, the competent authorities shall inform the relevant notified body and the authority responsible for the notified body of the measure taken. 31 31 IE: adding 75a: "Market surveillance authorities shall take appropriate measures to alert users within their territories within an adequate timeframe of hazards they have identified relating to any product so as to reduce the risk of injury or other damage" 6804/14 PM/ns 28 DGB 4B LIMITE EN Chapter IX Confidentiality, data protection, funding, penalties Article 84 Confidentiality 1. Unless otherwise provided in this Regulation and without prejudice to existing national provisions and practices in the Member States on medical confidentiality, all parties involved in the application of this Regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the following: (a) personal data in compliance with Article 85 Directive 95/46/EC and Regulation (EC) No 45/2001; (b) commercial interests of a natural or legal person, including intellectual property rights; (c) the effective implementation of this Regulation, in particular for the purpose of inspections, investigations or audits. 2. Without prejudice to paragraph 1, information exchanged between competent authorities and between competent authorities and the Commission on condition of confidentiality shall remain confidential unless the originating authority has agreed to its disclosure. 3. Paragraphs 1 and 2 shall not affect the rights and obligations of the Commission, Member States and notified bodies with regard to exchange of information and the dissemination of warnings, nor the obligations of the persons concerned to provide information under criminal law. 4. The Commission and Member States may exchange confidential information with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements. 6804/14 PM/ns 29 DGB 4B LIMITE EN Article 85 Data protection 1. Member States shall apply Directive 95/46/EC to the processing of personal data carried out in the Member States pursuant to this Regulation. 2. Regulation (EC) No 45/2001 shall apply to the processing of personal data carried out by the Commission pursuant to this Regulation. Article 86 Levy of fees 1. This Regulation shall be without prejudice to the possibility for Member States to levy fees for the activities set out in this Regulation, provided that the level of the fees is set in a transparent manner and on the basis of cost recovery principles. They 2. Member States shall inform the Commission and the other Member States at least three months before the structure and level of fees is to be adopted. Article 87 Penalties The Member States shall32 lay down the provisions on penalties applicable for infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate, and dissuasive. The Member States shall notify those provisions to the Commission by [3 months prior to the date of application of the Regulation] and shall notify it without delay of any subsequent amendment affecting them. 32 DE: "may" instead of "shall". Pres.: standard provision that can also be found in Article 87 of Regulation (EU) No 528/2012 (biocidal products); Article 24 of Directive 2011/83 (consumer rights); Article 37 of Regulation (EC) No 1223/2009 (cosmetic products); Article 11 of Regulation (EC) No 595/2009 (motor-vehicles); etc. 6804/14 PM/ns 30 DGB 4B LIMITE EN Chapter X Final provisions Article 88 Committee procedure 1. The Commission shall be assisted by a Committee on Medical Devices. That Committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply. 3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply. 4. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 4 or Article 5, as appropriate, shall apply. Article 89 Exercise of the delegation 1. The power to adopt the delegated acts referred to in Articles 2(2) and (3), 4(5), 8(2), 17(4), 24(7), 25(7), 29(2), 40(2), 41(4), 42(11), 45(5), 51(7), 53(3), 74(4) and 81(6) is conferred on the Commission subject to the conditions laid down in this Article. 6804/14 PM/ns 31 DGB 4B LIMITE EN 2. The delegation of power referred to in Articles 2(2) and (3), 4(5), 8(2), 17(4), 24(7), 25(7), 29(2), 40(2), 41(4), 42(11), 45(5), 51(7), 53(3), 74(4) and 81(6) shall be conferred on the Commission for an indeterminate period of time from the date of entry into force of this Regulation. 3. The delegation of power referred to in Articles 2(2) and (3), 4(5), 8(2), 17(4), 24(7), 25(7), 29(2), 40(2), 41(4), 42(11), 45(5), 51(7), 53(3), 74(4) and 81(6) may be revoked at any time by the European Parliament or by the Council. A decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect the day following its publication in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to any of the Articles listed in paragraph 1 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period may be extended by two months at the initiative of the European Parliament or the Council. Article 90 Urgency procedure for delegated acts 1. Delegated acts adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2. The notification of a delegated act to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure. 6804/14 PM/ns 32 DGB 4B LIMITE EN 2. Either the European Parliament or the Council may object to a delegated act in accordance with the procedure referred to in Article 89. In such a case, the Commission shall repeal the act without delay following the notification of the decision to object by the European Parliament or the Council. Article 91 Amendments to Directive 2001/83/EC In Annex I of Directive 2001/83/EC, point 12 of Section 3.2. is replaced by the following: ‘(12) Where a product is governed by this Directive in accordance with the second subparagraph of Article 1(4) or the second subparagraph of Article 1(5) of Regulation (EU) […/…] on medical devices33, the marketing authorisation dossier shall include, where available, the results of the assessment of the conformity of the device part with the relevant general safety and performance requirements of Annex I of that Regulation contained in the manufacturer’s EU declaration of conformity or the relevant certificate issued by a notified body allowing the manufacturer to affix a CE marking to the medical device. If the dossier does not include the results of the conformity assessment referred to in the first subparagraph and where for the conformity assessment of the device, if used separately, the involvement of a notified body is required in accordance with Regulation (EU) […/…], the authority shall require the applicant to provide an opinion on the conformity of the device part with the relevant general safety and performance requirements of Annex I of that Regulation issued by a notified body designated in accordance with that Regulation for the type of device in question, unless the authority is advised by its experts for medical devices that involvement of a notified body is not required.’ 33 OJ L […], […], p. […]. 6804/14 PM/ns 33 DGB 4B LIMITE EN Article 92 Amendments to Regulation (EC) No 178/2002 In the third subparagraph of Article 2 of Regulation (EC) No 178/2002, the following point (i) is added: ‘(i) medical devices within the meaning of Regulation (EU) […/…]34.’ Article 93 Amendments to Regulation (EC) No 1223/2009 In Article 2 of Regulation (EC) No 1223/2009, the following paragraph is added: ‘4. In accordance with the regulatory procedure referred to in Article 32(2), the Commission may, at the request of a Member State or on its own initiative, adopt the necessary measures to determine whether or not a specific product or group of products falls within the definition ‘cosmetic product’.’ Article 94 Transitional provisions 1. From the date of application of this Regulation any publication of a notification in respect of a notified body in accordance with Directives 90/385/EEC and 93/42/EEC shall become void. 2. Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC prior to the entry into force of this Regulation shall remain valid until the end of the period indicated on the certificate, except for certificates issued in accordance with Annex 4 of Directive 90/385/EEC or Annex IV of Directive 93/42/EEC which shall become void at the latest two years after the date of application of this Regulation. Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC after the entry into force of this Regulation shall become void at the latest two years after the date of application of this Regulation. 3. By way of derogation from Directives 90/385/EEC and 93/42/EEC, devices which comply with this Regulation may be placed on the market before its date of application. 34 OJ L […], […], p. […]. 6804/14 PM/ns 34 DGB 4B LIMITE EN 4. By way of derogation from Directives 90/385/EEC and 93/42/EEC, conformity assessment bodies which comply with this Regulation may be designated and notified before its date of application. Notified bodies which are designated and notified in accordance with this Regulation may apply the conformity assessment procedures laid down in this Regulation and issue certificates in accordance with this Regulation before its date of application. 5. By way of derogation from Article 10a and point (a) of Article 10b(1) of Directive 90/385/EEC and Article 14(1) and (2) and points (a) and (b) of Article 14a(1) of Directive 93/42/EEC, manufacturers, authorised representatives, importers and notified bodies who, during the period from [date of application] until [18 months after date of application], comply with Article 25(2) and (3) and Article 45(4) of this Regulation shall be considered to comply with the laws and regulations adopted by Member States in accordance with, respectively, Article 10a of Directive 90/385/EEC or Article 14(1) and (2) of Directive 93/42/EEC and with, respectively, point (a) of Article 10b(1) of Directive 90/385/EEC or points (a) and (b) of Article 14a(1) of Directive 93/42/EEC as specified in Commission Decision 2010/227/EU. 6. Authorisations granted by competent authorities of the Member States in accordance with Article 9(9) of Directive 90/385/EEC or Article 11(13) of Directive 93/42/EEC shall keep the validity indicated in the authorisation. 7. Devices falling within the scope of this Regulation in accordance with point (e) of Article 1(2) which have been legally placed on the market or put into service in accordance with the rules in force in the Member States prior to the application of this Regulation may continue to be placed on the market and put into service in the Member States concerned. 8. Clinical investigations which have started to be conducted in accordance with Article 10 of Directive 90/385/EEC or Article 15 of Directive 93/42/EEC prior to the application of this Regulation may continue to be conducted. As of the application of this Regulation, however, the reporting of serious adverse events and device deficiencies shall be carried out in accordance with this Regulation. 6804/14 PM/ns 35 DGB 4B LIMITE EN Article 95 Evaluation No later than seven years after the date of application, the Commission shall assess the application of this Regulation and establish an evaluation report on the progress towards achievement of the objectives of the Regulation including an assessment of resources required to implement this Regulation. Article 96 Repeal Council Directives 90/385/EEC and 93/42/EEC are repealed with effect from [date of application of this Regulation], with the exception of Article 10a and point (a) of Article 10b(1) of Directive 90/385/EEC and Article 14(1) and (2) and points (a) and (b) of Article 14a(1) of Directive 93/42/EEC which are repealed with effect from [18 months after date of application]. References to the repealed Council Directives shall be understood as reference to this Regulation and shall be read in accordance with the correlation table laid down in Annex XVI. Article 97 Entry into force and date of application 1 This Regulation shall enter into force on the twentieth day after its publication in the Official Journal of the European Union. 2. It shall apply from [three years after entry into force]. 3. By way of derogation from paragraph 2 the following shall apply: (a) Article 25(2) and (3) and Article 45(4) shall apply from [18 months after date of application referred to in paragraph 2]; 6804/14 PM/ns 36 DGB 4B LIMITE EN (b) Articles 28 to 40 and Article 78 shall apply from [six months after entry into force]. However, prior to [date of application as referred to in paragraph 2], the obligations on notified bodies emanating from the provisions in Articles 28 to 40 shall apply only to those bodies which submit an application for notification in accordance with Article 31 of this Regulation. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 26.9.2012 For the European Parliament For the Council The President The President _______________________ Upon request, the synthesis shall be made available to the notified body that issued the certificate in accordance to Article 45 and to the competent authorities of the Member States. (a) any serious incident, wherever it happens; (b) any field safety corrective action3F in respect of devices made available on the Union market, including any field safety corrective action undertaken in a third country in relation to a device which is also legally made available on the Union ma... 1a. Manufacturers shall make the report the incident referred to in the first subparagraph without delay, [through the electronic system referred to in Article 62], as soon as they have become aware of the incident or they have adopted4F the field s... (a) 2 days in the case of serious public health treat; (b) 7 days in the case of serious incidents. 1c. Where necessary to ensure timely reporting, the manufacturer may submit an initial incomplete report followed up by a complete report, no later than […] days5F after the incident or the adoption of the field safety corrective action. (a) the initial and final reports by manufacturers on serious incidents and field safety corrective actions referred to in Article 61(1); (b) the periodic summary reports by manufacturers referred to in Article 61(2); (c) the reports by competent authorities on serious incidents referred to in the second subparagraph of Article 63(1); (d) the reports by manufacturers on trends referred to in Article 64; (da) the periodic safety update reports referred to in Article 65a; (e) the field safety notices by manufacturers referred to in Article 63(5); (f) the information to be exchanged between the competent authorities of the Member States and between them and the Commission in accordance with Article 63(4) and (7). (a) the Member State where the incident occurred; (b) the Member State where the field safety corrective action is being or is to be undertaken; (c) the Member State where the manufacturer has his registered place of business; (d) where applicable, the Member State where the notified body, that issued a certificate in accordance with Article 45 for the device in question, is established. 9F Article 63 Analysis of serious incidents and field safety corrective actions 1a. Manufacturers shall perform appropriate investigations of the reported serious incident and the involved devices, monitored by the competent authorities referred to in points (a), (b) and (c) of Article 62(5). However, manufacturers shall consult ... The content of the field safety notice shall be made accessible to the public by the competent authority through the electronic system referred to in Article 62. The manufacturer shall enter the field safety notice in the electronic system referred to in Article 62 through which that notice shall be accessible to the public. (a) where similar serious incidents related to the same device or type of device of the same manufacturer occur in more than one Member State; (b) where the field safety corrective action is being or is to be undertaken in more than one Member State. 13F Unless otherwise agreed between the competent authorities, the coordinating competent authority shall be the one of the Member State where the manufacturer or the authorised representative has his registered place of business. The coordinating competent authority shall inform [through the electronic system referred to in Article 62] the manufacturer, the other competent authorities and the Commission that it has assumed the role of coordinating authority (a) to monitor the investigation of the serious incident by the manufacturer and the corrective action to be taken; (b) to consult with the notified body that issued a certificate in accordance with Article 45 for the device in question regarding the impact of the serious incident on the certificate; (c) to agree with the manufacturer and the other competent authorities referred to in points (a) to (c) of Article 62(5) on the format, content and frequency of periodic summary reports in accordance with Article 61(2); (d) to agree with the manufacturer and other competent authorities concerned on the implementation of the appropriate field safety corrective action; (e) to inform the other competent authorities and the Commission, through the electronic system referred to in Article 62, of the progress in and the outcome of its assessment. The designation of a coordinating competent authority shall not affect the rights of the other competent authorities to perform their own assessment and to adopt measures in accordance with this Regulation in order to ensure the protection of public ... a) economic operators shall to make available the documentation and information necessary for the purpose of carrying out their activities and, where necessary and justified, enter take provide the necessary samples of devices. Where appropriate, the competent authorities of the Member States shall agree on work-sharing, joint market surveillance activities and specialisation, for example in specific device technologies, processes or surveillance methods. (a) information in relation to non-compliant devices presenting a [serious] risk to health and safety referred to in Article 70(2), (4) and (6); (b) information in relation to compliant devices presenting a risk to health and safety referred to in Article 72(2); (c) information in relation to formal non-compliance of products referred to in Article 73(2); (d) information in relation to preventive health protection measures referred to in Article 74(2); (e) information of the results of the reviews and assessments of the surveillance of the activities of the Member States and information of the results of the cooperation referred to in Article 67(3). Article 70 Procedure for dealing with non-compliant devices presenting a risk to health and safety They shall notify the Commission and the other Member States and the notified body that issued a certificate in accordance with Article 45 for the device concerned, without delay, of those measures, by means of the electronic system referred to in Art... Article 7228F Procedure for dealing with compliant devices presenting a risk to health and safety 2a. The economic operators shall ensure that all appropriate corrective action is taken in respect of all the devices concerned that they have made available on the market. 3. The Commission shall evaluate the provisional national measures taken. On the basis of the results of that evaluation, the Commission shall decide, by means of implementing acts, whether or not the measure is justified. Those implementing acts shal... 4. Where the national measure is considered justified, Article 70(8) shall apply. If the national measure is considered unjustified, the Member State concerned shall withdraw the measure. (a) that the CE marking has been affixed in violation of the formal requirements laid down in Article 18; (b) that the CE marking has not been affixed to a device contrary to Article 18; (c) that the CE marking has been inappropriately affixed in accordance with procedures in this Regulation on a product that is not covered by this Regulation; (d) that the EU declaration of conformity has not been drawn up in conformity with this Regulation or is not complete; (e) that the information to be supplied by the manufacturer on the label or in the instructions for use is not available, not complete or not provided in the language(s) required in conformity with this Regulation; (f) that the technical documentation, including the clinical evaluation, is not available or not complete in conformity with this Regulation. Article 74 Preventive health protection measures On duly justified imperative grounds of urgency relating to the health and safety of humans, the Commission may adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 88(4). Where in this case imperative grounds of urgency so require, the procedure provided for in Article 90 shall apply to delegated acts adopted pursuant to this paragraph. Article 75 Good administrative practice (a) personal data in compliance with Article 85 Directive 95/46/EC and Regulation (EC) No 45/2001; (b) commercial interests of a natural or legal person, including intellectual property rights; (c) the effective implementation of this Regulation, in particular for the purpose of inspections, investigations or audits. Article 85 Data protection 2. The delegation of power referred to in Articles 2(2) and (3), 4(5), 8(2), 17(4), 24(7), 25(7), 29(2), 40(2), 41(4), 42(11), 45(5), 51(7), 53(3), 74(4) and 81(6) shall be conferred on the Commission for an indeterminate period of time from the date... Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC after the entry into force of this Regulation shall become void at the latest two years after the date of application of this Regulation. 4. By way of derogation from Directives 90/385/EEC and 93/42/EEC, conformity assessment bodies which comply with this Regulation may be designated and notified before its date of application. Notified bodies which are designated and notified in accor... Article 95 Evaluation (a) Article 25(2) and (3) and Article 45(4) shall apply from [18 months after date of application referred to in paragraph 2]; (b) Articles 28 to 40 and Article 78 shall apply from [six months after entry into force]. However, prior to [date of application as referred to in paragraph 2], the obligations on notified bodies emanating from the provisions in Articles 28 to 40 sh...