Suche

Nachfolgend zum Bericht über das 16. Industry Stakeholder Platform Meeting hat nun auch die Europäische Arzneimittel-Agentur (EMA) ihren Highlight Report veröffentlicht. Als Themenbereiche wurde die neue EU-Pharmagesetzgebung, die Variation-Regulation, das Revamp-Projekt, die Planbarkeit von Antragseinreichungen und die Einführung von elektronischer Produktinformationen (ePI) für Impfstoffe besprochen. Dazu sind auf der Webseite der EMA auch folgende Präsentationen verfügbar: Presentation - Implementation of the New Pharmaceutical Legislation (NPL) (M. Fanari; M. Vogl; Z. Hanaizi; F. Day; A. Spinei, EMA) Presentation - Submission predictability and revamp pilot (F. Day, EMA) Presentation - Revamp update (C. Pothet, EMA) Presentation - Pre-Submission Interactions Group (PreSIG) - Proposal to pilot a revised pre-submission interaction model (T.Castelnovo, EMA) Presentation - ePI update: roadmap and next steps (E.Scanlan, EMA) Presentation - Using EMA assessments for reliance in post-approval changes (V.Palmi, EMA) Presentation - Update on digitalisation initiatives affecting centralised procedure submissions (M. Duta-Mare; K. Puusaari; S. Griniene, EMA)

BERLIN Friedrichstraße 134 10117 Berlin BONN Ubierstraße 71–73 53173 Bonn Pharma Deutschland e. V. info@pharmadeutschland.de www.pharmadeutschland.de BRÜSSEL Rue Marie de Bourgogne 58 1000 Brüssel Ihre Ansprechpartner in der Pharma Deutschland-Pressestelle: Hannes Hönemann Leiter Abteilung Presse- und Öffentlichkeitsarbeit M: +49-171-5618203 hoenemann@pharmadeutschland.de Anna Frederike Gutzeit CvD Presse- und Öffentlichkeitsarbeit M: +49-170-4548014 gutzeit@pharmadeutschland.de Pressemitteilung Bundestag beschließt Standortdestabilisierungsgesetz Pharma Deutschland fordert unverzüglichen Start einer echten Pharmastrategie Berlin (10. Juli 2026) – Die harten Einschnitte, die sich aus dem heute verabschiedeten GKV-Beitragssatzstabilisierungsgesetz für die Pharmaindustrie ergeben, werden einem massiven Flurschaden in der deutschen Wirtschaftslandschaft hervorrufen. Das Gesetz wird als Standortdestabilisierungsgesetz in die Geschichte der Gesundheitspolitik eingehen: Noch nie hat ein Gesetz aus dem Bundesgesundheitsministerium eine strategisch so wichtige Branche in so kurzer Zeit mit einer derart geballten Kumulation von Eingriffen belastet, die sich additiv auf über 50 Prozent addieren können. Und das auf Basis von bereits unter AMNOG verhandelten Arzneimittelpreisen. „Dieses Gesetz ist kein Beitrag zur Stabilisierung der GKV, sondern ein Beitrag zur Destabilisierung des Wirtschaftsstandorts Deutschland und ein Schock für die Branche”, sagt der Pharma Deutschland Vorstandsvorsitzende Jörg Wieczorek. “Noch im November sind wir im Bundeskanzleramt als zu stärkende Leitbranche empfangen worden. Ein paar Monate später werden wir mit immer neuen Abschlägen, Rabatten und Preiseinschnitten überzogen. Die Teilnahmslosigkeit, mit der die Spitze des Wirtschaftsministeriums die Entwicklung schon seit den desillusionierenden Pharmagesprächen begleitet, ist ein verheerendes Signal an Unternehmen aller Branchen und nicht nur denen, die hier forschen, produzieren und investieren wollen.“ Pharma Deutschland weist darauf hin, dass die heute beschlossenen Eingriffe den innovationsgetriebenen Teil der Arzneimittelversorgung treffen, in dem Arzneimittel für schwere und chronische Erkrankungen entwickelt werden. Um in einer Zeit multipler Bedrohungslagen nicht weitere systemrelevante Unternehmen und Produktionsstrukturen zu verlieren, fordert mailto:hoenemann@pharmadeutschland.de 2 Pharma Deutschland die Bundesregierung auf, unverzüglich mit der Formulierung einer Pharmastrategie zu beginnen. „Die Bundesregierung muss ihren eigenen Anspruch endlich ernst nehmen. Wenn sie tatsächlich noch eine Pharmastrategie für Deutschland will, dann muss sie die pharmazeutische Industrie jetzt an den Tisch holen, strukturiert an der Ausarbeitung beteiligen und sofort mit der Arbeit beginnen und in die Praxis umsetzen. Alles andere ist industriepolitisch unglaubwürdig und destabilisiert weiter“, so Jörg Wieczorek. _______________ Der Pharma Deutschland e.V. ist der mitgliederstärkste Branchenverband der Pharmaindustrie in Deutschland. Er vertritt die Interessen von rund 400 Mitgliedsunternehmen, die in Deutschland ca. 80.000 Mitarbeiterinnen und Mitarbeiter beschäftigen. Die in Pharma Deutschland e.V. organisierten Unternehmen tragen maßgeblich dazu bei, die Arzneimittelversorgung in Deutschland zu sichern. So stellen sie fast 80 Prozent der in Apotheken verkauften rezeptfreien und fast zwei Drittel der rezeptpflichtigen Arzneimittel sowie einen Großteil der stofflichen und dentalen Medizinprodukte für die Patientinnen und Patienten bereit. Unter www.pharmadeutschland.de gibt es mehr Informationen zu Pharma Deutschland. http://www.pharmadeutschland.de/

„Dieses Gesetz ist kein Beitrag zur Stabilisierung der GKV, sondern ein Beitrag zur Destabilisierung des Wirtschaftsstandorts Deutschland und ein Schock für die Branche.” Jörg Wieczorek Vorstandsvorsitzender “Noch im November sind wir im Bundeskanzleramt als zu stärkende Leitbranche empfangen worden. Ein paar Monate später werden wir mit immer neuen Abschlägen, Rabatten und Preiseinschnitten überzogen. Die Teilnahmslosigkeit, mit der die Spitze des Wirtschaftsministeriums die Entwicklung schon seit den desillusionierenden Pharmagesprächen begleitet, ist ein verheerendes Signal an Unternehmen aller Branchen und nicht nur denen, die hier forschen, produzieren und investieren wollen.“ Pharma Deutschland weist darauf hin, dass die heute beschlossenen Eingriffe den innovationsgetriebenen Teil der Arzneimittelversorgung treffen, in dem Arzneimittel für schwere und chronische Erkrankungen entwickelt werden. Um in einer Zeit multipler Bedrohungslagen nicht weitere systemrelevante Unternehmen und Produktionsstrukturen zu verlieren, fordert Pharma Deutschland die Bundesregierung auf, unverzüglich mit der Formulierung einer Pharmastrategie zu beginnen. „Die Bundesregierung muss ihren eigenen Anspruch endlich ernst nehmen. Wenn sie tatsächlich noch eine Pharmastrategie für Deutschland will, dann muss sie die pharmazeutische Industrie jetzt an den Tisch holen, strukturiert an der Ausarbeitung beteiligen und sofort mit der Arbeit beginnen und in die Praxis umsetzen. Alles andere ist industriepolitisch unglaubwürdig und destabilisiert weiter“, so Jörg Wieczorek.

Was ist das Ziel des Sparpakets? Warken machte klar, dass es um eine gemeinsame Kraftanstrengung geht. «Alle Beteiligten im Gesundheitswesen leisten einen Beitrag, denn alle profitieren auch langfristig von einer nachhaltigen Finanzierung.» Die Reform sei nötig, denn mit der jetzigen Ausgabendynamik liefe es sonst über kurz oder lang auf einen «Systemkollaps» hinaus. Die zentrale Stoßrichtung lautet nun, dass die Ausgaben der gesetzlichen Krankenkassen nur noch so stark steigen sollen, wie es die Einnahmenentwicklung hergibt. Und bezahlt werden soll prinzipiell nur noch, was die Versorgung nachweislich verbessert. Ausgangspunkt für die Pläne waren Ende März vorgelegte Empfehlungen einer Expertenkommission. Um wie viele Milliarden geht es? Die Leistungsausgaben der Kassen stiegen im vergangenen Jahr schon auf gut 336 Milliarden Euro und legten im ersten Quartal 2026 mit plus acht Prozent noch rasanter zu als angenommen. Warken setzte das Sparziel für 2027 vor diesem Hintergrund erst vor vier Wochen noch auf 18,8 Milliarden Euro herauf. Da der vom Kabinett auf den Weg gebrachte Entwurf nur 16,3 Milliarden Euro abdeckte, mussten also Lösungen für 2,5 Milliarden Euro her. Die Lücke werde mit dem geänderten Entwurf geschlossen, sagte die Ministerin im Parlament - ob gerade so auf Kante genäht oder noch mit etwas Puffer, blieb vorerst unklar. Was kommt für Patientinnen und Patienten? Warken sagte, es bleibe ein «ausgewogenes Paket», das alle Beteiligten einbeziehe - also eben auch die Versicherten. Konkret müssen sie sich auf Einschnitte bei Leistungen und mehr Zahlungen aus eigener Tasche einstellen: Seit 22 Jahren geltende Zuzahlungen von mindestens 5 und höchstens 10 Euro etwa fürs Abholen verschriebener Medikamenten in der Apotheke sollen auf 7,50 bis 15 Euro angehoben werden. Wieder gestrichen wurde, dass die Zuzahlungen dann auch noch jährlich angepasst werden sollen. Homöopathische Leistungen soll es nicht mehr auf Kassenkosten geben. Die alle zwei Jahre mögliche Hautkrebsvorsorge für alle Erwachsenen ohne Symptome soll überprüft werden. Festzuschüsse für Zahnersatz sollen von 60 Prozent auf 50 Prozent der Kosten sinken, Härtefallregeln bleiben aber. Für Gutverdiener soll die Beitragsbemessungsgrenze 2027 zusätzlich um 300 Euro angehoben werden. Aktuell liegt die Grenze, die ohnehin jährlich erhöht wird, bei 5.812,50 Euro. Bis zu dieser Schwelle des Monatsgehalts sind Beiträge fällig, vom darüber liegenden Gehalt nicht mehr. Die kostenlose Mitversicherung von Ehegatten und Lebenspartnern soll beschränkt werden, nun aber mit größeren Ausnahmen. Bleiben soll sie für Eltern von Kindern unter zwölf statt unter sieben Jahren sowie für Eltern von Kindern mit Behinderungen, für Erwerbsgeminderte, für Menschen im Regel-Rentenalter und wenn pflegebedürftige Angehörige betreut werden. Für andere noch kostenlos mitversicherte Partner sollen Kassenmitglieder ab 2028 aber einen Beitragszuschlag von 2,5 Prozent zahlen. Um unnötige Eingriffe zu vermeiden, soll etwa vor OPs für künstliche Kniegelenke erst eine zweite ärztliche Meinung eingeholt werden müssen. Angesichts hoher Fehlzeiten im Job soll bei langwierigeren Erkrankungen eine Teilkrankschreibung ermöglicht werden, wenn Beschäftigte und Arbeitgeber es möchten – mit 25, 50 und 75 Prozent der Wochenstunden. Wo soll noch gespart werden? Vergütungsanstiege für alle Leistungserbringer wie Ärzte und Kliniken werden begrenzt. Bei den Praxen fallen Extra-Vergütungen weg. Für Apotheken und Pharmaindustrie sollen verstärkte Rabattregelungen gelten. Gekippt wurde ein «dynamischer» Preisabschlag für Arzneihersteller, der jährlich zu erhöhen wäre. Stattdessen soll ein erhöhter fester Extra-Abschlag kommen. Bei den Kassen werden Verwaltungs- und Werbeausgaben begrenzt. Sie müssen Versicherte auch nicht mehr eigens über Erhöhungen des Zusatzbeitrags informieren - zur Entbürokratisierung, wie es heißt. Die Verbraucherzentralen warnten, damit werde das dann bestehende Sonderkündigungsrecht faktisch ausgehöhlt. Was trägt der Bund selbst zum Sparpaket bei? Auch in Koalitionsreihen Kritik ausgelöst hatte, dass der Bund zunächst vor allem Geld für den eigenen Etat herausziehen wollte. Da wurde nachgebessert: Für die Krankenkosten von Grundsicherungsbeziehern, die generell gesetzlich versichert sind, soll es mehr Steuergeld geben - zunächst eine Milliarde Euro statt 250 Millionen Euro zusätzlich für 2027, die Summe soll dann noch steigen. Und der reguläre Bundeszuschuss an die Kassen von jährlich 14,5 Milliarden Euro soll 2027 nur auf 13,15 Milliarden statt auf 12,5 Milliarden Euro herunter. Wie geht es weiter? Anders als Ende 2025 ist nun frühzeitigere Klarheit in Sicht, wenn es um die Finanzplanungen fürs Folgejahr geht. Ob der Puffer reicht, Beitragsanhebungen zu vermeiden, muss sich zeigen. Die Opposition meldete schon Zweifel an. Viele Kassen müssen weiter Rücklagen auf vorgeschriebene Mindestwerte auffüllen. Aktuell liegen die Zusatzbeiträge, die die Kassen jeweils für sich festlegen, im Schnitt bei 3,1 Prozent. Zum Gesamtbeitrag, den sich Arbeitnehmer und Arbeitgeber teilen, gehört außerdem der allgemeine Satz von 14,6 Prozent des Bruttolohns. Per Entschließung im Bundestag kündigten Union und SPD auch Regelungen zum Absichern der psychotherapeutischen Versorgung an, die es nicht mehr ins Gesetz schafften - Umsetzung gleich nach der Sommerpause.

Ziel des Gesetzentwurfs ( Bundestag-Drucksache 21/6808 ) ist eine besser abgestimmte, bedarfsgerechte und wirtschaftliche Versorgung von Patientinnen und Patienten in Akut- und Notfällen. Kern des Entwurfs ist eine engere Verzahnung von vertragsärztlichem Notdienst, Notaufnahmen und Rettungsdienst. Künftig sollen Integrierte Notfallzentren (INZ) mit zentraler Ersteinschätzung die Patientinnen und Patienten gezielter in die passende Versorgungsebene steuern. Weitere Regelungen: Die Rufnummer 116 117 soll künftig Terminservice- und Akutleitstelle umfassen und digital mit den Rettungsleitstellen unter 112 vernetzt werden. Zudem soll die medizinische Notfallrettung als Sachleistung der gesetzlichen Krankenversicherung verankert werden. Vorgesehen sind außerdem Möglichkeiten zur Abgabe von Arzneimitteln und apothekenpflichtigen Medizinprodukten in bestimmten Notfallkonstellationen, Maßnahmen zur Reanimation sowie ein bundesweites Kataster öffentlich zugänglicher Defibrillatoren. Für die Digitalisierung der Notfallrettung sind von 2027 bis 2031 insgesamt 225 Millionen Euro vorgesehen.

Das würde sich direkt auf kommunale Haushalte auswirken, betonte Hoch. Die Kommunen seien verpflichtet, für die Aufrechterhaltung der medizinischen Versorgung finanziell einzuspringen. «Das wäre ein sehr schwieriger Weg.» Klinikchef: «Das tut uns weh» Die Universitätsmedizin Mainz, die einzige Uniklinik von Rheinland-Pfalz, rechnet durch das geplante Gesetz zur Stabilisierung der Beiträge in der gesetzlichen Krankenversicherung mit einer zusätzlichen Belastung von rund 25 Millionen Euro pro Jahr. «Das tut uns weh», sagte der Vorstandsvorsitzende Ralf Kiesslich der dpa. Das mache den Weg der Entschuldung nochmal schwieriger. «Ich kann nur sagen, dass es im Bereich komplexer universitärer Medizin schwierig ist, zu sparen», betonte der Klinikchef. «Die Universitätskliniken sind das Rückgrat, wir sind in Krisen immer dafür da, auch Dinge möglich zu machen, die an anderer Stelle nicht mehr gehen.» Minister Hoch sagte, die Bundesregierung habe an einigen Stellen des Pakets zwar noch gearbeitet, die «alten Sorgenthemen» seien aber geblieben. Es bleibe auch die Frage, wie im Land ein ordentlicher Pharmastandort organisiert werde. Er stehe dazu in einem engen Austausch mit Wirtschaftsminister Michael Ebling (SPD). «Wir fühlen uns nicht als Gewinner» Aus der Pharmabranche meldete sich der Deutschlandchef von Boehringer Ingelheim, Médard Schoenmaeckers, zu Wort. Er sagte der dpa, es gebe eine Bewegung in eine Richtung, bei der die Industrie de-priorisiert werde. Der Grundtenor sei nach Änderungen an dem Gesetzentwurf nach wie vor, dass Innovationen der Pharmabranche nicht anerkannt würden. «Wir fühlen uns nicht als Gewinner», sagte Schoenmaeckers. Es bleibe das Gefühl, dass die Industrie der einzige Kostenträger sei, der weiter zusätzlich belastet werde. Dass ein ursprünglich geplanter dynamisch anpassbarer Preis-Abschlag auf Medikamente nun doch nicht kommen soll, begrüßte Schoenmaeckers. «Aber die Industrie sieht sich nun mit einem mehr als doppelt so hohen, konstanten Herstellerabschlag konfrontiert.» Insgesamt vermisst der Manager des Unternehmens, das im Juni eigentlich geplante Investitionen von 900 Millionen Euro in Deutschland gestoppt hatte, Anerkennung von Innovation. Hoch: Bräuchten eigentlich Vermittlungsausschuss Gesundheitsminister Hoch sagte: «Meine Haltung ist: Wie es jetzt läuft, ist es nicht gut.». Seit Wochen seien sich alle Länder einig, dass der Bund sich noch bewegen müsse. «Eigentlich bräuchten wir einen Vermittlungsausschuss», sagte Hoch. «Wir werden aber abwarten müssen, was in der Koordinierungsrunde am Donnerstagabend besprochen wird.» Noch sei unklar, was Gespräche über das Gesetz ergeben Die Bundesregierung will das Sparpaket für stabile Krankenkassenbeiträge noch vor der Sommerpause verabschieden. Ob die Länder da mitmachen, ist unklar. Darüber hinaus geht der Opposition auf Bundesebene der Zeitplan angesichts der umfassenden Änderungen zu schnell. Grünen-Gesundheitsexperten Janosch Dahmen hatte dazu das Bundesverfassungsgericht in Karlsruhe angerufen, das Eilanträge gegen das Gesetzgebungsverfahren jedoch ablehnte. Für Rheinland-Pfalz sagte Minister Hoch mit Blick auf den Bundesrat: «Wir haben freie Hand im Kabinett vereinbart, weil wir hoffen, dass die Bundesregierung noch einlenken wird.» Er sei selbst gespannt, was bis Freitag noch passiere.

Die beiden Antragsteller, Janosch Dahmen von Bündnis 90/Die Grünen und Ates Gürpinar von Die Linke, hatten geltend gemacht, durch umfangreiche und kurzfristig vorgelegte Änderungsanträge in ihrem Recht auf gleichberechtigte Teilhabe an der parlamentarischen Willensbildung verletzt zu sein. Sie verwiesen dabei auf Parallelen zum Gesetzgebungsverfahren zum Gebäudeenergiegesetz im Jahr 2023. Mit den Eilanträgen sollte dem Deutschen Bundestag untersagt werden, den Gesetzentwurf wie geplant abschließend zu beraten. Die Anträge blieben ohne Erfolg. Damit wird die parlamentarische Beratung voraussichtlich planmäßig fortgesetzt. Grundlage der 2. und 3. Lesung ist die Beschlussvorlage des Bundestagsgesundheitsausschusses. Noch nicht offiziell liegt der Entschließungsantrag der Regierungsfraktionen vor, der unter anderem eine Aufforderung an die Bundesregierung enthalten soll, im Rahmen des Pharma- und Medtech-Dialogs eine Standortklausel unter Berücksichtigung des Beihilferechts zu entwickeln. Offen ist zudem, ob das Gesetz bereits morgen im 2. Durchgang im Bundesrat behandelt wird.

BERLIN Friedrichstraße 134 10117 Berlin, Germany T. 030 | 308 75 96 - 0 F. 030 | 308 75 96 - 111 BONN Ubierstraße 71–73 53173 Bonn, Germany T. 0228 | 957 45 - 0 F. 0228 | 957 45 - 90 Pharma Deutschland e. V. info@pharmadeutschland.de www.pharmadeutschland.de BRÜSSEL Rue Marie de Bourgogne 58 1000 Brüssel T. +49-170-6133687 Position on the Draft Report of the Committee on Public Health on the proposal for a Regulation amending Regulation (EU) 2017/745 as regards the simplification and reduction of regulatory burdens for medical devices (COM(2025) 1023 final) Date: 9 July 2026 Pharma Deutschland e.V. represents the interests of the pharmaceutical and medical device industry at both federal and state levels to politics, authorities, and institutions in the healthcare sector. With around 400 member companies, it is the largest association in the pharmaceutical and medical device sector. The political advocacy and member support extend to the area of prescription and non- prescription drugs as well as medical devices, such as medical apps and digital health applications. General Support for the EU Proposal to Simplify and Streamline Medical Device Regulation Pharma Deutschland welcomes the European Parliament’s objective to simplify the EU regulatory framework for medical devices and to enhance the competitiveness of the European medical device sector within the internal market and at global level. Most of the amendments proposed by the European Parliament are well suited to simplifying regulatory procedures, increasing predictability and reducing administrative burdens, while maintaining a high level of patient safety. These amendments should therefore be retained. In particular, this applies to: • Digitalisation – enabling the broader use of electronic instructions for use (eIFU) • Simplification for products intended for professional users – allowing certain information to be provided in English • Increased transparency and stakeholder involvement – strengthening the participation of manufacturers, notified bodies and industry associations in various regulatory procedures • Greater legal clarity – revising classification Rule 14 for medical devices incorporating a medicinal substance and classification Rule 21 for substance-based medical devices Pharma Deutschland’s Position on Commission Proposal for Simplification of MDR | JULY 2026 2 Need for further improvements and addressing unresolved issues under the MDR Nevertheless, several areas require further improvement. The following analysis focuses on those proposed changes that are of greatest relevance and necessity for Pharma Deutschland members, namely manufacturers of substance‑based medical devices, dental medical devices and software. The sections below set out specific topics and elements of the proposal that would benefit from further refinement. Pharma Deutschland therefore proposes amendments to the following legal provisions: • Recital 11a • Recital 39 • Article 1(8) – Subject matter and scope • Article 2 – Definitions • Article 4 – Regulatory Status of Products • Article 4a – Opinion on and determination of the regulatory status of a product • Article 15 – Person responsible for regulatory compliance • Article 18(3) – Implant card and information to be supplied to the patient with an implanted device • Article 60 – Certificate of free sale • Article 61(5) – Clinical evaluation • Article 86(1) third subparagraph – Periodic safety update report (PSUR) • Article 97 – Other non-compliance • Article 106b – Support by the EMA • Annex VIII – Classification Rules - Rules 6 and 7 - Rule 11 Pharma Deutschland’s Position on Commission Proposal for Simplification of MDR | JULY 2026 3 ▪ Recital 11 a Pharma Deutschland welcomes the inclusion of Recital 11 a in the Draft Report. The smooth functioning of the internal market and confidence in the CE marking system should not be undermined by duplicative or unnecessary layers of regulatory oversight. The principles set out in proposed Recital 11a of the Draft Report should be incorporated into Article 4 to ensure they have binding legal effect. Draft Report Recital 11 a Amendment 4 Proposed Change (11a) For a device which has been subject to the conformity assessment procedure involving the participation of a notified body and which consequently bears the CE marking, the coordination mechanism should not beintended to operate as a parallel post-certification review in a manner that could affect legal certainty and the predictability of the certification process. Accordingly, that mechanism should be used in relation to such devices only where there is substantiated evidence that the device presents an unacceptable risk, due to its regulatory classification. (11a) For a device which has been subject to the conformity assessment procedure involving the participation of a notified body and which consequently bears the CE marking, the coordination mechanism should not be intended to operate as a parallel post-certification review in a manner that could affect legal certainty and the predictability of the certification process. Accordingly, that mechanism should be used in relation to such devices only where there is substantiated evidence that the device presents an unacceptable risk, due to its regulatory status or its classification. The product's regulatory status shall not, in itself, be considered substantiated evidence. Justification The Regulation provides for procedures to determine both the regulatory status of a product and the classification of a device. These procedures are also referred to in Recital 11. Legal certainty and predictability should be ensured throughout the certification process in both cases. The proposed amendment would contribute to achieving this objective. Pharma Deutschland’s Position on Commission Proposal for Simplification of MDR | JULY 2026 4 ▪ Recital 39 The Regulation has significantly tightened the conditions for relying on equivalence, making it considerably more challenging for manufacturers to use this pathway. For implantable devices and class III devices, manufacturers seeking to rely on equivalence with a competitor's marketed device in order to avoid conducting a clinical investigation must meet particularly stringent requirements. Among other things, they must have a contract granting them continuous and unrestricted access to the technical documentation of the equivalent device. In addition, the clinical evaluation of the equivalent device must have been conducted in compliance with the MDR requirements. In practice, these conditions are rarely met, as competitors are generally unwilling to provide unrestricted access to their technical documentation. As a result, reliance on equivalence has become exceptionally difficult for implantable and class III devices under the MDR. The European Commission has proposed measures to make the use of equivalence more feasible in practice while maintaining a high level of patient safety. Pharma Deutschland welcomes this approach. In many cases, relevant clinical data are already available for devices that are equivalent to the device undergoing conformity assessment. Requiring manufacturers to generate additional clinical data in such situations may result in unnecessary duplication of efforts and increased regulatory costs without providing a corresponding benefit for patient safety. Draft Report Recital 39 Amendment 9 Proposed Change (39) Clinical data are often available for devices that are equivalent to the device under conformity assessment. In order to make the conditions under which manufacturers can claim equivalence more flexible, the requirement in Regulation (EU) 2017/745 for a contract with the manufacturer of the equivalent device granting access to its technical documentation should therefore be removed and the equivalence criteria be adapted. Justification Facilitating the use of equivalence would support innovation, improve access to new medical technologies and reduce unnecessary regulatory burden, while maintaining the Regulation’s high safety standards. Pharma Deutschland’s Position on Commission Proposal for Simplification of MDR | JULY 2026 5 ▪ Subject matter and scope Article 1(8) Article 1(8) has not been amended either by the Commission proposal or by the Draft Report. However, the Draft Report proposes an amendment to Rule 14, which Pharma Deutschland fully supports (Amendment 122). Since Article 1(8) establishes the concept of an ancillary medicinal substance and Rule 14 governs the classification of medical devices incorporating such substances, both provisions should be aligned to ensure legal certainty and consistent application. Draft Report Article 1(8) Original Text Proposed Change 8. Any device which, when placed on the market or put into service, incorporates, as an integral part, a substance which, if used separately, would be considered to be a medicinal product as defined in point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma as defined in point 10 of Article 1 of that Directive, and that has an action a clinically relevant ancillary action contributing to the intended medical purpose to that of the device shall be assessed and authorised in accordance with this Regulation. Justification Substance-based medical devices often contain substances which, if used separately, can be considered to be medicinal products. However, the amounts of those substances present in substance-based medical devices are often not clinically relevant to the fulfilment of the intended medical purpose. An example constitutes substances having merely the function to preserve the formulation and are therefore used as preservatives. Consequently, they do not contribute to the intended medical purpose. This proposed change intends to clarify that a substance can only be considered as an ancillary medicinal substance if it has a clinically relevant ancillary action in order to achieve the intended medical purpose of the device. This amendment would align Article 1(8) with Amendment 122 of the Draft Report concerning Rule 14, thereby enhancing legal certainty and ensuring consistent application of these provisions. Pharma Deutschland’s Position on Commission Proposal for Simplification of MDR | JULY 2026 6 ▪ Definitions Article 2(7) The European Commission proposes to amend the definition of the term “generic device group” by replacing the current alternative conditions with cumulative ones. The Draft Report does not propose any amendments to this provision. However, the existing definition is more proportionate and better aligned with the regulatory objectives. Draft Report Article 2(7) Original Text Proposed Change (7) ‘generic device group’ means a set of devices having the same or similar intended purposes or and a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics. Justification Replacing alternative conditions with cumulative conditions narrows the scope of the definition set in Article 2(7) and increases the internal homogeneity of the product group concerned. As a consequence, this approach would lead to a larger number of products being subject to conformity assessment activities under the applicable sampling plan. The proposition would maintain the current provision of Article 2(7), which is based on alternative conditions. Pharma Deutschland’s Position on Commission Proposal for Simplification of MDR | JULY 2026 7 ▪ Definitions Article 2(72) The European Commission’s proposal introduces a new definition of the term “well-established technology device” and removes the current list of products. This initiative is welcomed. However, a limited clarification or minor amendment would still be necessary to ensure legal certainty and consistent application. The Draft Report’s proposal to clarify the second criterion is therefore welcomed. Nevertheless, the wording of the second part of this criterion, which contains cumulative conditions, remains unclear and may lead to divergent interpretations. Draft Report Article 2(72) Amendment 13 Proposed Change (72) ‘well-established technology device’ means a device that belongs to a generic device group, which fulfils the following criteria: a) it has simple, common and stable design; b) it has well-known safety history and has not been associated with safety issues in the past; c) it has well-known clinical performance characteristics and comprises standard of care devices with little evolution in indications and the state of the art; d) it has a long history on the Union market;’ (72) ‘well-established technology device’ means a device that belongs to a generic device group, which fulfils the following criteria: a) it has simple, common and stable design; b) it has a well-known safety history and has not been associated with safety issues in the past; c) it has well-known clinical performance characteristics and comprises standard of care devices with little evolution in indications and the state of the art; d) it has a long history on the Union market;’ Justification It is proportionate and appropriate to extend the regulatory simplifications to all devices that demonstrably qualify as well-established technology device independent of the risk class. This proposal reflects their proven clinical performance, safety and low-risk profile. This approach would enhance regulatory efficiency while maintaining high standards of patient safety. However, the term “safety issues” is not defined in the Regulation, which may lead to divergent interpretations by notified bodies. Pharma Deutschland’s Position on Commission Proposal for Simplification of MDR | JULY 2026 8 ▪ Regulatory Status of Products Article 4 The current version of Article 4 includes a legally binding procedure for the determination of the regulatory status of a product. Such a procedure has been missing under the former Directive 93/42/EEC on medical devices and therefore it is an appreciated improvement. As no procedure according to the current Article 4 MDR has been conducted yet, it remains unclear why the European Commission suggests an amendment to this provision. Draft Report Article 4 Amendments 17, 18, 19, 20 and 21 Proposed Change Regulatory Status of Products 1. The competent authorities of the Member States shall coordinate their activities when determining whether a specific product, or category, or group of products, that has been placed on the market falls within the definition of ‘medical device’ set out in Article 2, point (1), or the definition of ‘accessory for a medical device’ set out in Article 2, point (2), or whether a product falls within the scope of Annex XVI or is an accessory for a product listed in that Annex. 2. The Member States shall ensure an appropriate level of consultation of the relevant competent authorities of the Member States in the fields of in vitro diagnostic medical devices, medicinal products, substances of human origin (SoHO), biocides, food products, cosmetics or other products subject to Union legislation, where the determination of whether a product has the regulatory status of a device involves aspects concerning the borderline with any of those types of products. If that is the case, Member States shall also ensure an appropriate level of consultation of the relevant advisory or regulatory bodies established in the relevant Union legislation, such as the European Medicines Agency (EMA), the SoHO Coordination Board, the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA). Regulatory Status of Products 1. The consulting competent authorities authority of the Member States and the competent authority of the Member State in which the manufacturer has its registered place of business shall coordinate their activities when determining whether a specific product, or category, or group of products, that has been placed on the market falls within the definition of ‘medical device’ set out in Article 2, point (1), or the definition of ‘accessory for a medical device’ set out in Article 2, point (2), or whether a product falls within the scope of Annex XVI or is an accessory for a product listed in that Annex. 2. The competent authorities of the Member States referred to in paragraph 1 shall ensure an appropriate level of consultation of the relevant competent authorities of the Member States in the fields of in vitro diagnostic medical devices, medicinal products, substances of human origin (SoHO), biocides, food products, cosmetics or other products subject to Union legislation, where the determination of whether a product has the regulatory status of a device involves aspects concerning the borderline with any of those types of products. If that is the case, Member States shall also ensure an appropriate level of consultation of the relevant advisory or regulatory bodies established in the relevant Union legislation, such as the European Medicines Agency (EMA), the SoHO Coordination Board, the Pharma Deutschland’s Position on Commission Proposal for Simplification of MDR | JULY 2026 9 3. Where a competent authority of a Member State, after having performed an evaluation in accordance with Article 94, has substantiated evidence considers that a product that is CE marked in accordance with Article 20, does not fall within the scope of this Regulation, it shall consult the competent authorities of the other Member States regarding its envisaged measure determining the regulatory status of the product in question. The consulting competent authority shall inform the concerned manufacturer and concerned notified body that has issued the certificate. 4. Where a competent authority of a Member State raises a substantiated disagreement regarding the envisaged measure referred to in paragraph 3, the consulting authority shall refer the matter to an expert panel as referred to in Article 106 and give utmost consideration to the opinion of that expert panel. 5. The results of the coordination activities of the competent authorities in accordance with this Article and the opinions of the expert panel delivered in accordance with paragraph 4 of this Article shall be made publicly available, without disclosing any confidential information as referred to in Article 109. 5a. Where necessary, to ensure the uniform application of this Regulation, and taking into account the opinion of the expert panel referred to in paragraph 4, the Commission may, by means of implementing acts, determine whether a product, CE-marked in accordance with Article 20, falls within the scope of this Regulation. 6. The Commission shall, by means of implementing acts, lay down the procedure, including timelines and involvement of concerned stakeholders, for the application of paragraphs 1 to 4 of this Article and of Article 4a. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3). European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA). 3. Where a competent authority of a Member State, after having performed an evaluation in accordance with Article 94, has substantiated evidence that a product that is CE marked in accordance with Article 20, does not fall within the scope of this Regulation, it shall consult the competent authorities authority of the other Member States in which the manufacturer has its registered place of business regarding its envisaged measure determining the regulatory status of the product in question. The consulting competent authority shall inform the concerned manufacturer and, where applicable, concerned notified body that has issued the certificate. 4. In cases where no agreement concerning the determination of the regulatory status of a specific product can be reached within the coordination referred to in paragraph 3, the consulting authority shall, prior to implementing national measures in accordance with Article 97, submit a substantiated request for an opinion from an expert panel referred to in Article 106, in accordance with Article 4a. 5. deleted 5a. deleted 6. deleted Pharma Deutschland’s Position on Commission Proposal for Simplification of MDR | JULY 2026 10 Justification The European Commission proposal and the Draft Report appear to seek to legally entrench the so- called Helsinki Procedure, a decision-making mechanism characterised by limited transparency and an insufficient scientific basis. The formally structured procedure proposed in the revised version of Article 4 is disproportionate, as a decision on the regulatory status of a product initiated by a single competent authority becomes decisive unless another competent authority raises a substantiated objection. For products that are CE-marked in accordance with Article 20, existing mechanisms already address situations where a device presents an unacceptable risk to patients or otherwise fails to comply with the requirements of the Regulation (Articles 94 and 97). The principle of the free movement of goods, as laid down in Article 24 MDR and Articles 34 and 36 TFEU and further explained in the Blue Guide, should be safeguarded to the greatest extent possible in order to ensure legal certainty for manufacturers. A proportionate approach would require a competent authority of a Member State that has substantiated evidence that a product which is CE marked in accordance with Article 20 does not fall within the scope of this Regulation, and which has conducted an evaluation pursuant to Article 94, to consult the competent authority of the Member State in which the manufacturer has its registered place of business, and inform the manufacturer and the notified body concerned. In the event of disagreement between the consulting competent authority and the competent authority of the Member State in which the manufacturer has its registered place of business, an expert panel should be consulted in accordance with Article 4a. There is no need to involve the competent authorities of all other Member States in such a procedure. Instead, those authorities should be informed of any expert panel opinions relating to the determination of the regulatory status of a CE-marked product in accordance with Article 4a. Pharma Deutschland’s Position on Commission Proposal for Simplification of MDR | JULY 2026 11 ▪ Opinion on and determination of the regulatory status of a product Article 4a The amendments proposed in the Draft Report do not allow manufacturers, developers or notified bodies to submit a substantiated request to an expert panel for a scientific and technical opinion on the determination of the regulatory status of a product. Such a possibility is, however, provided for questions relating to the classification of devices under proposed Articles 51a and 51b. Draft Report Article 4a Amendments 22, 23, 24, 25 and 26 Proposed Change Opinion on and determination of the regulatory status of a product 1. A competent authority may submit a substantiated request for an opinion from an expert panel referred to in Article 106 on the question whether a specific product, falls within the definitions of ‘medical device’ or ‘accessory for a medical device’, or whether a product falls within the scope of Annex XVI or is an accessory for a product listed in that Annex. Where, in such a request, the requester considers that the product in question is a device, the request shall also specify the proposed classification of the device in accordance with Article 51 and Annex VIII. 2. The expert panel shall provide its opinion within 30 days from receipt of a complete request. The requester shall give utmost consideration to the opinion of the expert panel when determining the regulatory status of the product. Any opinion of an expert panel in relation to the determination of the regulatory status, shall be made publicly available, without disclosing any confidential information as referred to in Article 109. 4. This Article shall not apply where within the framework of another Union legislation the regulatory status of the product, or category or group of products concerned has been determined as falling within the scope of that other Union legislation, or where a procedure for the determination of the regulatory status is Opinion on and determination of the regulatory status of a product 1. A competent authority, a notified body, a manufacturer, a developer of a product or the Commission may submit a substantiated request for an opinion from an expert panel referred to in Article 106 on the question whether a specific product, or category or group of products, falls within the definitions of ‘medical device’ or ‘accessory for a medical device’, or whether a product falls within the scope of Annex XVI or is an accessory for a product listed in that Annex. Where, in such a request, the requester considers that the product in question is a device, the request shall also specify the proposed classification of the device in accordance with Article 51 and Annex VIII. 2. Where the request concerns a device that is CE marked in accordance with Article 20, the expert panel shall, before issuing its opinion, consult the competent authority of the Member State in which the manufacturer has its registered place of business, the manufacturer and, where applicable, the notified body concerned. 3. In determining whether a product may fall within a regulatory status other than that applicable to medical devices, the expert panel shall take due account of whether the product concerned is capable of complying with the Pharma Deutschland’s Position on Commission Proposal for Simplification of MDR | JULY 2026 12 ongoing within the framework of another Union legislation. requirements of the sector-specific legislation governing the proposed regulatory category. Where the proposed regulatory status is that of a medicinal product, the assessment shall include consideration of whether, having regard to the mechanism of action described by the manufacturer, the product is capable of obtaining the relevant marketing authorisation in accordance with the applicable legal requirements. The assessment shall further take into account the potential impact of the proposed reclassification on the availability of treatment options for patients. 4. The expert panel, referred to in Article 106, shall deliver an opinion on the determination of the regulatory status of the device within 90 days. The opinion shall include the reasons for the proposed regulatory status. The competent authority may ask the expert panel for clarifications on its opinion. 5. Within 30 days of receipt of the expert panel opinion, or any requested clarification, the competent authority shall adopt its decision. The competent authority shall follow the expert panel opinion, unless it provides duly justified reasons for departing from it. It shall notify the other Member States and the Commission of its decision without undue delay. 6. The opinions of the expert panel in relation to the determination of the regulatory status of a product that is CE marked in accordance with Article 20 shall be made publicly available, without disclosing any confidential information as referred to in Article 109. 7. On the basis of an expert panel opinion issued under this Article, the Commission may, following a substantiated request, adopt an implementing act to clarify the regulatory status of a specific product. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 114(3). Pharma Deutschland’s Position on Commission Proposal for Simplification of MDR | JULY 2026 13 Justification For devices in development that are not CE-marked in accordance with Article 20, national mechanisms already exist that enable developers to consult the competent authority of the Member State in which they have their registered place of business in order to obtain an opinion on the regulatory status of a product (e.g. Section 6 of the German Medical Devices Implementation Act (MPDG)). Only in cases of disagreement should a developer be able to request an opinion from an expert panel, in order to avoid long-lasting national administrative court decisions without legal effect for other Member States. This corresponds to our proposition set out in Article 4a(1). This would enhance legal certainty, increase confidence in regulatory decisions and help avoid situations where CE-marked devices are subsequently withdrawn from the market as a result of a reassessment of their regulatory status. In accordance with the case law of the European Court of Justice, the regulatory status of a product shall be determined through a case-by-case assessment. Consequently, references to product categories or groups should be deleted, as they may undermine an individual assessment of each product. Furthermore, our proposition aligns with the proposed Articles 51a and 51b on classification issues of devices, taking into account the amendments introduced by the Draft Report. It would strengthen the role of expert panels in addressing complex questions regarding the regulatory status of products by enabling the submission of substantiated requests for scientific and technical opinions. This would enhance consistency and legal certainty while ensuring that final decisions on regulatory status remain within the established regulatory framework. To ensure a proportionate and predictable approach, the assessment of the expert panel should take into account whether the product concerned is capable of complying with the requirements applicable to the proposed regulatory category. This would help prevent situations in which a product cannot subsequently obtain the authorisations required under the new regulatory framework, resulting in its withdrawal from the market and a potential reduction in the availability of treatment options for patients. The Commission would not be automatically involved, thereby preserving its resources and administrative capacity. Pharma Deutschland’s Position on Commission Proposal for Simplification of MDR | JULY 2026 14 ▪ Person responsible for regulatory compliance Article 15 The European Commission has amended Article 15 by removing the obligation for a person seeking to become the Person Responsible for Regulatory Compliance (PRRC) to demonstrate specific formal qualifications. The Draft Report does not propose any amendments to this provision. While the deletion of the requirement for a specific diploma, certificate, or other formal qualification is welcomed, the tasks assigned to the PRRC nevertheless require that this person possesses appropriate and sufficient professional experience. Draft Report Article 15 Original Text Proposed Change 1. Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices. The requisite expertise shall be demonstrated by four years of professional experience in regulatory affairs or in quality management systems relating to medical devices. Without prejudice to national provisions regarding professional qualifications, manufacturers of custom-made devices may demonstrate the requisite expertise referred to in the first subparagraph by having at least two years of professional experience within a relevant field of manufacturing. […] 6. Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory requirements for medical devices in the Union. The requisite expertise shall be demonstrated by four years of professional experience in regulatory affairs or in quality management systems relating to medical devices. Pharma Deutschland’s Position on Commission Proposal for Simplification of MDR | JULY 2026 15 Justification The functions assigned to the PRRC require a certain level of qualification. The requirement set out in the current Article 15(1)(a) for a diploma, certificate or other evidence of formal qualification appears to be superfluous. Nevertheless, the PRRC must possess a basic understanding of regulatory and quality management matters, which is indispensable for the proper fulfilment of their responsibilities. Therefore, the requirement laid down in the current version of Article 15(1)(b) should not be deleted. The same applies to the current version of Article 15(6)(b). The removal of the obligation for micro and small enterprises relying on an external PRRC to ensure that this person is available “permanently and continuously”, replacing it with a general availability requirement in Article 15(2), is welcomed. This change better reflects the operational realities of these manufacturers while maintaining an adequate level of regulatory oversight. Pharma Deutschland’s Position on Commission Proposal for Simplification of MDR | JULY 2026 16 ▪ Implant card and information to be supplied to the patient with an implanted device Article 18(3) The current provision of the Regulation provides an exemption from the obligations to issue an implant card and to provide information to patients with implanted devices for a defined list of implants. The European Commission proposes replacing this list with the concept of “well- established technology devices”, which is reflected in the proposed amendment to Article 18(3). The deletion of this amendment in the Draft Report would remove this simplification and result in a significant administrative burden for manufacturers of well-established implantable devices, while offering limited added value in terms of patient safety. Draft Report Article 18(3) Amendment 42 Proposed Change 3. Implants that are well-established technology devices shall be exempted from the obligations laid down in this Article; Justification Requiring manufacturers of simple implantable devices, such as sutures, to provide an implant card and patient information would constitute a disproportionate regulatory burden. Given the nature of these devices, such requirements would offer little or no added value for patient safety. Pharma Deutschland’s Position on Commission Proposal for Simplification of MDR | JULY 2026 17 ▪ Certificate of free sale Article 60 The European Commission has amended Article 60 by introducing a new paragraph 1b, which establishes an obligation for competent authorities to publish certificates of free sale in EUDAMED. The Draft Report does not propose any amendments to this provision. This additional requirement is critical and raises significant concerns. Draft Report Article 60(1b) Original Text Proposed Change Deletion of the proposed Article 60(1b). The competent authority shall make the certificates of free sale issued in accordance with paragraphs 1 and 1a publicly available in Eudamed. Justification Certificates of free sale typically contain information on the manufacturer, the product trade name, the Basic UDI-DI and the third country for which the certificate is issued. The disclosure of the information contained in certificates of free sale does not provide any added value for patient safety or public health. Moreover, trade relations with third countries shall fall outside the scope and purpose of Eudamed. Manufacturers have a legitimate interest in not disclosing sensitive information on their commercial relationships with non-EU trade partners. Pharma Deutschland’s Position on Commission Proposal for Simplification of MDR | JULY 2026 18 Clinical evaluation Article 61(5) The European Commission has proposed measures to make the use of equivalence more feasible in practice while maintaining a high level of patient safety. Pharma Deutschland welcomes this approach. In many cases, relevant clinical data are already available for devices that are equivalent to the device undergoing conformity assessment. Requiring manufacturers to generate additional clinical data in such situations may result in unnecessary duplication of efforts and increased regulatory costs without providing a corresponding benefit for patient safety. Draft Report Article 61(5) Amendment 92 Proposed Change 5. A manufacturer of a device, different from a class III implantable, demonstrated to be equivalent to an already marketed device not manufactured by it, may also rely on paragraph 4 in order not to perform a clinical investigation provided that the original clinical evaluation, including clinical data from a clinical investigation of the equivalent device, has been performed in compliance with the requirements of this Regulation and the manufacturer provides clear evidence thereof to the notified body. A manufacturer of a device, different from a class III implantable, demonstrated to be equivalent to an already marketed device not manufactured by it, may also rely on paragraph 4 in order not to perform a clinical investigation provided that the original clinical evaluation, including clinical data from a clinical investigation of the equivalent device, has been performed in compliance with the requirements of this Regulation and the manufacturer provides clear evidence thereof to the notified body. Justification This proposition would restore the approach originally proposed by the European Commission, which is considered more proportionate. Reliance on equivalence is only possible where the equivalent device is supported by clinical data generated in accordance with the MDR requirements. Furthermore, manufacturers must comply with strict criteria when demonstrating equivalence. Consequently, an additional risk-based restriction on the use of equivalence is unnecessary and would further limit an already highly constrained regulatory pathway. Pharma Deutschland’s Position on Commission Proposal for Simplification of MDR | JULY 2026 19 ▪ Periodic safety update report (PSUR) Article 86(1) third subparagraph The European Commission has amended Article 86(1), third subparagraph, by allowing manufacturers of class IIa devices to update the PSUR whenever necessary. This amendment is welcomed, as it reduces unnecessary administrative burden while maintaining the existing level of safety. However, the Draft Report proposes to reintroduce an obligation to update the PSUR at least once during the first two years following the issuance of the certificate. Draft Report Article 86(1) third subparagraph Amendment 96 Proposed Change Manufacturers of class IIa devices and non- implantable class IIb devices shall update the PSUR at least once in the first two years after the certificate is issued and when necessary. The PSUR shall be part of the technical documentation specified in Annex III. Manufacturers of class IIa devices and non- implantable class IIb devices shall update the PSUR at least once in the first two years after the certificate is issued and when necessary. The PSUR shall be part of the technical documentation specified in Annex III. Justification This proposition would restore the approach originally proposed by the European Commission, which is considered more proportionate because it reduces administrative burden while maintaining the current level of patient safety. Pharma Deutschland’s Position on Commission Proposal for Simplification of MDR | JULY 2026 20 ▪ Other non-compliance Article 97 Article 97 lays down provisions applicable in cases of “other non-compliances” concerning CE- marked devices that do not present an unacceptable risk to the health or safety of patients, as identified by national authorities in the course of their market surveillance activities. From the perspective of legal certainty for manufacturers of CE-marked devices, as well as the principles of proportionality and feasibility of corrective measures and the clear allocation of roles and responsibilities between authorities and economic operators, the proposed amendments to Article 97 raise concerns. In particular, they may give rise to divergent interpretations and potentially conflict with the principles of the New Legislative Framework and the free movement of goods within the European Union, notably in situations involving differing views on the regulatory status or classification of a CE-marked device. Draft Report Article 97 Original Text Proposed Change 1. Where, having performed an evaluation pursuant to Article 94, the competent authorities of a Member State find that a device or an economic operator does not comply with the requirements laid down in this Regulation but does not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health, they shall require the relevant economic operator to bring the non-compliance concerned to an end within a reasonable period that is clearly defined and communicated to the economic operator and that is proportionate to the non-compliance. The assessment of compliance shall take due account of the respective roles and responsibilities of economic operators as set out in Articles 10, 11, 13, 14 and 16. In the case of device-related non-compliances, the relevant economic operator shall be the manufacturer. 2. Where the economic operator does not bring the non-compliance to an end within the period referred to in paragraph 1, the Member State concerned shall, where the non-compliance relates to the device, and after consulting the competent authority responsible for the Pharma Deutschland’s Position on Commission Proposal for Simplification of MDR | JULY 2026 21 manufacturer, without delay, take all appropriate measures to restrict or prohibit the product being made available on the national market or to ensure that it is recalled or withdrawn from the national 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 100. 2a. The economic operator shall take any appropriate corrective action pursuant to paragraph 1 or 2 throughout the Union in respect of all the devices concerned that they have made available on the market, unless a competent authority takes other appropriate measures. 3. By way of derogation from paragraphs 1 and 2, where a competent authority holds a dissenting view on the regulatory status or the classification of a CE‑marked device, it shall follow the procedures laid down in Articles 4 and 51b of this Regulation. Pending the outcome of those procedures, the free movement of the CE‑marked device shall remain protected in accordance with Article 24 of this Regulation. 4. In order to ensure the uniform application of this Article, the Commission may, by means of implementing acts, specify appropriate measures to be taken by competent authorities to address given types of non-compliance. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3). Justification It is acknowledged that market surveillance activities may include an assessment of the regulatory status or classification of a CE-marked device. However, in light of the CE marking and the protection of the free movement of goods pursuant to Article 24, measures restricting or prohibiting the making available of a device on the market, or requiring its recall or withdrawal, must remain the responsibility of the competent authority of the manufacturer. This applies insofar as the device does not present an unacceptable risk to the health or safety of patients that would justify immediate action by other national authorities. Pharma Deutschland’s Position on Commission Proposal for Simplification of MDR | JULY 2026 22 Where a national authority holds a dissenting view on the regulatory status or classification of a CE-marked device, and where no consensus can be reached following consultation with the manufacturer and its competent authority, the national authority may initiate the applicable legal procedures for the determination of the regulatory status in accordance with Article 4 and, where relevant, for the determination of the classification under Article 51b. By contrast, where a product has already been classified as a device and bears a CE marking in another Member State, a national authority must first apply the procedures laid down in the legal framework for medical devices before applying classification procedures under other Union legislation (see judgment of the European Court of Justice of 3 October 2013, Case C-109/12). Any national measure taken without a transparent and objective procedure in accordance with Article 4 (and by analogy Article 51ff.) would therefore be contrary to the case law of the Court and would infringe the manufacturer’s rights under the principle of the free movement of goods. Finally, with regard to proportionality, it must be emphasised that the application of Article 97 presupposes that the CE-marked device concerned does not present an unacceptable risk to health or safety. Where such a risk exists, Article 95 applies. Consequently, in the absence of a safety concern, there is no justification for immediate national measures without awaiting the outcome of the legal procedures provided for under Articles 4 and 51 ff. Pharma Deutschland’s Position on Commission Proposal for Simplification of MDR | JULY 2026 23 ▪ Support by the EMA Article 106b Since 2022, the EMA has provided the secretariat for the expert panels. The Commission’s proposal includes support from the EMA to the competent authorities to improve coordination between them, especially with regard to borderline cases and classification issues, derogations from applicable conformity assessment procedures and possibly other requirements, clinical evaluations and investigations, vigilance and market surveillance. The Draft Report does not propose any amendments to this provision. Draft Report Article 106b Original Text Proposed Change Deletion of proposed Article 106b. Given the specific characteristics of the medical device sector, establishing a separate, truly impartial, specialised Office for medical devices may be a more effective long-term solution than transferring these tasks to the EMA. Justification The EMA’s technical and human resources are of particular concern. The agency currently has only limited specific expertise in the field of medical devices, especially when compared with its many years of experience in the regulation of medicinal products. Without a substantial expansion of its technical expertise, there is a risk that the EMA will formally assume a central role while being unable in practice to fulfil this role with the necessary depth and quality. This poses a particular risk for substance-based medical devices, combination products and complex demarcation issues. Furthermore, the role of the EMA in the decision-making process remains unclear. The agency is expected to coordinate, support and promote exchange without being granted any decision-making powers of its own. This intermediate position risks leading to a diffusion of responsibility, as national authorities may rely on the EMA while it remains unclear who ultimately bears responsibility for substantive assessments and potential incorrect decisions. Furthermore, there is little reason to believe that the EMA would refrain from actively influencing decisions regarding the regulatory status of products. Access to EUDAMED and other electronic systems also presents a mixed picture. While it allows for improved coordination and analysis of vigilance and market surveillance data, it simultaneously raises questions regarding data sovereignty, the allocation of responsibilities and practical integration into existing national workflows. Pharma Deutschland’s Position on Commission Proposal for Simplification of MDR | JULY 2026 24 ▪ Annex VIII - Classification Rules Rules 6 and 7 Classification Rules 6 and 7 have been amended in the Commission’s proposal to clarify that reusable surgical instruments should be classified as class I, regardless of the part of the body with which they come into contact. This clarification is welcomed. However, it should be extended to cover all surgical instruments and should not be limited to reusable instruments only. The Draft Report does not propose any amendments to this provision. Draft Report Rule 6 Original Text Proposed Change All surgically invasive devices intended for transient use are classified as class IIa unless they: - are intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with those parts of the body, in which case they are classified as class III; - are reusable surgical instruments regardless of the body part with which they come into contact, in which case they are classified as class I; - are intended specifically for use in direct contact with the heart or central circulatory system or the central nervous system, in which case they are classified as class III; - are intended to supply energy in the form of ionising radiation in which case they are classified as class IIb; - have a biological effect or are wholly or mainly absorbed in which case they are classified as class IIb; or are intended to administer medicinal products by means of a delivery system, if such administration of a medicinal product is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are classified as class IIb. Pharma Deutschland’s Position on Commission Proposal for Simplification of MDR | JULY 2026 25 Draft Report Rule 7 Original Text Proposed Change All surgically invasive devices intended for short- term use are classified as class IIa unless they: - are intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with those parts of the body, in which case they are classified as class III; - are intended specifically for use in direct contact with the heart or central circulatory system or the central nervous system, in which case they are classified as class III; - are intended to supply energy in the form of ionizing radiation in which case they are classified as class IIb; - have a biological effect or are wholly or mainly absorbed in which case they are classified as class III; - are intended to undergo chemical change in the body in which case they are classified as class IIb, except if the devices are placed in the teeth; or - are intended to administer medicines, in which case they are classified as class IIb; - are reusable surgical instruments regardless of the body part with which they come into contact, in which case they are classified as class I; Justification Under the current framework, a surgical instrument supplied sterile and intended for single use is classified in a higher risk class (class IIa) than an otherwise identical device that is labelled as reusable (class I) and therefore must be cleaned, disinfected and sterilised by the user prior to first use and before each subsequent use. This differentiation is neither comprehensible nor risk-based and leads to a contradictory regulatory outcome. Reuse of a device requires additional reprocessing steps by the user and entails a higher risk of improper handling or contamination than a device that is supplied sterile and intended for single use only. The proposed change affects not only the Classification Rules 6 and 7 but also Annex VIII Chapter I Nr. 2.3 and the regulations for the conformity assessment in Article 52 (7, first paragraph). Pharma Deutschland’s Position on Commission Proposal for Simplification of MDR | JULY 2026 26 ▪ Annex VIII - Classification Rules Rule 11 Classification Rule 11 has been amended in the Commission’s proposal with the aim of assigning lower risk classes to software. This objective is very welcome. However, the proposed revision of Rule 11 does not achieve its stated goal of simplification. On the contrary, it risks increasing legal uncertainty and may ultimately discourage innovation in digital health solutions within the EU market. The proposed amendments in the Draft Report (Amendments 117 ff.) are not achieving the objective of simplification and proportionality. Draft Report Rule 11 Amendments 117, 118, 119 and 120 Proposed Change Software which is intended to generate an output that confers a clinical benefit and is used for diagnosis, treatment, prevention, monitoring, prediction, prognosis, compensation or alleviation of a disease or condition is classified as class I, unless the output is intended: - in treat or diagnose a disease or condition in a critical situation, in which case it is classified as class III; - in treat or diagnose a disease or condition in a serious situation, or to drive clinical management of a disease or condition in a critical situation in which cases it is classified as class IIb; - in treat or diagnose a disease or condition in a non-serious situation, or to drive clinical management of a disease or condition in a serious situation or to inform clinical management of a disease or condition in a critical or serious situation in which case it is classified as class IIa; Software which is intended to generate an output that confers a clinical benefit and is used for diagnosis, treatment, prevention, monitoring, prediction, prognosis, compensation or alleviation of a disease or condition is classified as class I, unless the output is intended to: - in treat or diagnose a disease or condition in a critical situation, in which case it is classified as class III; - in treat or diagnose a disease or condition in a serious situation, or to drive clinical management of a disease or condition in a critical situation in which cases it is classified as class IIb; - in treat a disease or condition in a non- serious situation where clinical management is required, or to drive clinical management of a disease or condition in a serious situation, or to inform clinical management of a disease or condition in a critical or serious situation, in which case it is classified as class IIa. Justification This proposition restores a genuine class I pathway for low-risk treatment software that neither relates to critical or serious conditions nor requires clinical management, consistent with the default classification rule in Annex I, point 6.6(g). The proposed approach ensures that low-impact treatment- Pharma Deutschland’s Position on Commission Proposal for Simplification of MDR | JULY 2026 27 support software is not subject to disproportionate regulatory requirements, while preserving a cautious classification in line with established risk-based classification principles, including the IMDRF framework. 2026-07-09_Deckblatt-2.pdf 2026-07-09_Pharma Deutschland Position_Draft Report_1

Zwei Bundestagsabgeordnete von Grünen und Linken hatten sich jeweils mit Eilanträgen an das höchste deutsche Gericht gewandt, weil sie das eilige Gesetzgebungsverfahren für unzulässig hielten. Die Regierungskoalition hatte demnach noch wenige Tage vor der geplanten Abstimmung 278 Seiten mit Änderungsanträgen vorgelegt. Koalition will Handlungsfähigkeit demonstrieren Das Paket von Gesundheitsministerin Nina Warken (CDU) soll die gesetzlichen Krankenkassen 2027 von stark steigenden Milliarden-Ausgaben entlasten, um erneute Beitragserhöhungen zu verhindern. Dafür sollen Vergütungsanstiege bei Praxen, Kliniken und der Pharmabranche begrenzt werden. Auf Patientinnen und Patienten kommen zum Beispiel Einschränkungen bei der kostenlosen Mitversicherung von Ehepartnern und höhere Zuzahlungen für Medikamente zu. Das umstrittene Spargesetz steht in einer Reihe weiterer Reformvorhaben, mit denen die schwarz-rote Koalition zum Sommer ihre Handlungsfähigkeit demonstrieren und Wirtschaftswachstum stimulieren will. Nach dem Plan der Koalition soll es morgen im Bundestag beschlossen werden und dann gleich in den Bundesrat kommen, der an dem Tag zum letzten Mal vor der Sommerpause tagt. Kläger kritisierten parlamentarisches Verfahren Der Grünen-Gesundheitsexperte Janosch Dahmen kritisierte am Mittwoch nach Beratungen im Gesundheitsausschuss des Bundestages, man habe «die vergangenen Tage ein chaotisches Gesetzgebungsverfahren erlebt». Er wolle daher von Karlsruhe überprüfen lassen, ob «in diesem Fall überhaupt noch ein ordnungsgemäßes parlamentarisches Verfahren möglich ist». Kurz darauf kündigten auch Linke und AfD an, Karlsruhe anzurufen zu wollen. Ein Antrag der AfD war zuletzt aber nach Angaben des Gerichts nicht eingegangen. Es ist nicht das erste Mal, dass mit einem Eilantrag in Karlsruhe die Verabschiedung eines Gesetzes vor der Sommerpause ausgebremst werden sollte. Im Sommer 2023 hatte der CDU-Abgeordnete Thomas Heilmann mit einem solchen Antrag das Gesetzgebungsverfahren zum Heizungsgesetz der Ampel-Regierung gestoppt. Er hatte argumentiert, den Abgeordneten sei für die Beratung zu wenig Zeit geblieben. Am 23. Juli - also etwa drei Jahre nach dem Eilantrag - entscheidet das Gericht über den Fall im Hauptsacheverfahren.