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Nur ein geringer Teil der Bevölkerung - vier Prozent - habe einen Weg von mehr als zehn Kilometern zur nächsten Apotheke. Die wohnortnahe Versorgung sei damit trotz einer sinkenden Zahl an Apotheken im Land gesichert. Längerer Weg zur Notdienst-Apotheke Ende 2024 gab es in Mecklenburg-Vorpommern laut Gesundheitsministerium in Schwerin noch 361 Apotheken. Zehn Jahre zuvor waren es noch 401. Das hat Folgen, etwa für den Notfall. Wer in der Nacht oder am Sonntag ein Medikament braucht, muss seit Jahresbeginn unter Umständen einen weiteren Weg in Kauf nehmen. Notdienst-Apotheken können in Mecklenburg-Vorpommern seither bis zu 35 Kilometer auseinander liegen. Zuvor galten 25 Kilometer.

Das Fachseminar bietet einen kompakten Überblick, vermittelt zentrale Grundlagen und schafft Orientierung für die praktische Arbeit im Gesundheitswesen. Programm und Details folgen.

Erfahren Sie in einem Halbtagsseminar kompakt, welche Entwicklungen bei PFAS, REACH, CLP & Co. derzeit die europäische Regulierung prägen und welche Auswirkungen sich daraus für die pharmazeutische Industrie ergeben können. Programm un Details fol

Folgende Punkte sind hervorzuheben: Die finalen Versionen der neuen Monographie zu Maydis stigma sowie der überarbeiteten Monographien zu Arnicae flos und Species diureticae wurden nach öffentlicher Konsultation angenommen. Die Monographien zu Anisi aetheroleum und Anisi fructus sollen überarbeitet werden. Eine Überarbeitung ist nicht notwendig bei den Monographien zu Salicis cortex und Salviae officinalis folium . Der Entwurf des Reflection Paper on particulars for safety signals for (traditional) herbal medicinal products (EMA/HMPC/PRAC/301178/2025) wurde zur öffentlichen Konsultation bis zum 15. Oktober 2026 angenommen. In Diskussion sind die Monographien zu: Valerianae radix/Passiflorae herba Betulae folium Myrrha Plantaginis ovatae semen Plantaginis ovatae seminis tegumentum Details können dem Bericht auf der Website der EMA entnommen werden. Sobald die in dem Bericht genannten Dokumente auf der EMA-Website publiziert sind, wird Pharma Deutschland weiter berichten.

Am 1. Oktober 2026 veranstaltet die Pharma Deutschland-Akademie das Online-Seminar „Variations“ . Neben der delegierten Verordnung (EU) 2024/1701 und der neuen Classification Guideline werden die praktische Durchführung von Änderungsverfahren und die elektronische Einreichung von Variation-Anträgen besprochen. Im Mittelpunkt der Veranstaltung stehen die Grundlagen des europäischen Systems zur Änderung von Arzneimittelzulassungen sowie die praktische Durchführung von Variation-Verfahren. Anhand von Beispielen aus dem Zulassungsalltag werden typische Fragestellungen und Fallstricke bei der Antragstellung erläutert. Die Veranstaltung richtet sich insbesondere an Mitarbeitende und Einsteiger pharmazeutischer Unternehmen aus dem Bereich Arzneimittelzulassung/Regulatory Affairs sowie an weitere Fachkräfte, die mit Änderungsverfahren befasst sind. Das Seminar findet am Donnerstag, den 1. Oktober 2026, von 9:30 Uhr bis ca. 16:00 Uhr als Online-Veranstaltung statt. Fachseminar zu Variations Neben der delegierten Verordnung (EU) 2024/1701 und der neuen Classification Guideline werden die praktische Durchführung von Änderungsverfahren und die elektronische Einreichung von Variation-Anträgen besprochen. Details & Anmeldung

Deutliche regionale Unterschiede Je nach Bundesland wird die psychische Gesundheitsversorgung unterschiedlich häufig als Herausforderung wahrgenommen. Regional zeigt sich ein Nord-Süd-Gefälle: In Schleswig-Holstein (43,7 Prozent), Mecklenburg-Vorpommern (40,2 Prozent) und Niedersachsen (41,2 Prozent) wird diese besonders problematisch eingeschätzt. Im Mittelfeld liegen Sachsen (40,7 Prozent), Rheinland-Pfalz (40,3 Prozent) und Brandenburg (38,0 Prozent). Vergleichsweise niedrig sind die Anteile in Baden-Württemberg (36,8 Prozent), Hessen (35,6 Prozent) und Bayern (33,4 Prozent). Deutliche Unterschiede zwischen den Altersgruppen Auch zwischen den Altersgruppen zeigen sich deutliche Unterschiede. Am häufigsten nehmen Menschen zwischen 40 und 49 Jahren die psychische Gesundheitsversorgung als Herausforderung wahr: 44,5 Prozent nennen diesen Versorgungsbereich. Es folgen die 50- bis 64-Jährigen (43,8 Prozent), die 30- bis 39-Jährigen (35,0 Prozent) und die 18- bis 29-Jährigen (38,4 Prozent). Am seltensten wird die psychische Gesundheitsversorgung in der Altersgruppe ab 65 Jahren als Herausforderung wahrgenommen (27,4 Prozent). Unterschiede zwischen den Geschlechtern Auch zwischen Frauen und Männern zeigen sich Unterschiede. Frauen nennen die psychische Gesundheitsversorgung etwas häufiger als Männer (38,9 gegenüber 34,7 Prozent). Ähnliche Wahrnehmung in Stadt und Land Ein klares Muster zeigt sich bei der Bevölkerungsdichte nicht. Die Anteile liegen in Regionen mit sehr niedriger Bevölkerungsdichte bei 35,0 Prozent, mit niedriger bei 37,1 Prozent, mit mittlerer bei 36,7 Prozent, mit hoher bei 36,5 Prozent und mit sehr hoher Bevölkerungsdichte bei 37,7 Prozent „Psychische Erkrankungen gehören zur gesundheitlichen Versorgung ebenso selbstverständlich wie körperliche Erkrankungen. Gegen Krankheiten wie Depressionen oder Angstzustände gibt es gute und bewährte Arzneimittel, deren Einnahme aber ärztlich veranlasst und begleitet werden muss. Umso wichtiger ist es, dass Menschen bei Bedarf zeitnah Zugang zu einer bedarfsgerechten Behandlung erhalten. Die Ergebnisse unserer Umfrage zeigen, welchen Stellenwert die psychische Gesundheitsversorgung aus Sicht der Bevölkerung inzwischen einnimmt.“ Dorothee Brakmann Hauptgeschäftsführerin Weitere Informationen und Grafiken finden Sie im Pharma Deutschland Gesundheitsmonitor .

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 Jeder dritte Deutsche hält die psychische Gesundheitsversorgung für eine Herausforderung Sorgen in Norddeutschland und bei Menschen zwischen 40 und 49 besonders groß Berlin (3. August 2026) – Die psychische Gesundheitsversorgung gehört aus Sicht vieler Menschen in Deutschland zu den größten Herausforderungen der medizinischen Versorgung. Eine repräsentative Civey-Umfrage im Auftrag von Pharma Deutschland zeigt: 37 Prozent der Befragten sehen sie als Herausforderung in ihrer unmittelbaren Wohnumgebung. Bundesweit wird lediglich die hausärztliche Versorgung häufiger als Problem genannt. Die Ergebnisse fallen in eine Zeit intensiver Debatten über die Finanzierung psychotherapeutischer Leistungen. Deutliche regionale Unterschiede Je nach Bundesland wird die psychische Gesundheitsversorgung unterschiedlich häufig als Herausforderung wahrgenommen. Regional zeigt sich ein Nord-Süd-Gefälle: In Schleswig-Holstein (43,7 Prozent), Mecklenburg-Vorpommern (40,2 Prozent) und Niedersachsen (41,2 Prozent) wird diese besonders problematisch eingeschätzt. Im Mittelfeld liegen Sachsen (40,7 Prozent), Rheinland-Pfalz (40,3 Prozent) und Brandenburg (38,0 Prozent). Vergleichsweise niedrig sind die Anteile in Baden-Württemberg (36,8 Prozent), Hessen (35,6 Prozent) und Bayern (33,4 Prozent). Deutliche Unterschiede zwischen den Altersgruppen Auch zwischen den Altersgruppen zeigen sich deutliche Unterschiede. Am häufigsten nehmen Menschen zwischen 40 und 49 Jahren die psychische Gesundheitsversorgung als Herausforderung wahr: 44,5 Prozent nennen diesen Versorgungsbereich. Es folgen die 50- bis 64-Jährigen (43,8 Prozent), die 30- bis 39-Jährigen (35,0 Prozent) und die 18- bis 29- mailto:hoenemann@pharmadeutschland.de 2 Jährigen (38,4 Prozent). Am seltensten wird die psychische Gesundheitsversorgung in der Altersgruppe ab 65 Jahren als Herausforderung wahrgenommen (27,4 Prozent). Unterschiede zwischen den Geschlechtern Auch zwischen Frauen und Männern zeigen sich Unterschiede. Frauen nennen die psychische Gesundheitsversorgung etwas häufiger als Männer (38,9 gegenüber 34,7 Prozent). Ähnliche Wahrnehmung in Stadt und Land Ein klares Muster zeigt sich bei der Bevölkerungsdichte nicht. Die Anteile liegen in Regionen mit sehr niedriger Bevölkerungsdichte bei 35,0 Prozent, mit niedriger bei 37,1 Prozent, mit mittlerer bei 36,7 Prozent, mit hoher bei 36,5 Prozent und mit sehr hoher Bevölkerungsdichte bei 37,7 Prozent. Dorothee Brakmann, Hauptgeschäftsführerin Pharma Deutschland ordnet die Ergebnisse ein: „Psychische Erkrankungen gehören zur gesundheitlichen Versorgung ebenso selbstverständlich wie körperliche Erkrankungen. Gegen Krankheiten wie Depressionen oder Angstzustände gibt es gute und bewährte Arzneimittel, deren Einnahme aber ärztlich veranlasst und begleitet werden muss. Umso wichtiger ist es, dass Menschen bei Bedarf zeitnah Zugang zu einer bedarfsgerechten Behandlung erhalten. Die Ergebnisse unserer Umfrage zeigen, welchen Stellenwert die psychische Gesundheitsversorgung aus Sicht der Bevölkerung inzwischen einnimmt.“ _______________ Im Auftrag von Pharma Deutschland führt das Meinungsforschungsinstitut Civey seit Januar 2025 ein kontinuierliches Live-Monitoring zur individuellen medizinischen Versorgungssituation sowie zu Erfahrungen im Kontext pharmazeutischer Themen durch. Die Anzahl der Antworten, die stellvertretend für die Grundgesamtheit in der Stichprobe zur Berechnung des repräsentativen Ergebnisses berücksichtigt werden, liegt bei 5.000 Befragten. Die erhobenen Daten werden nach den sechs Landesverbänden von Pharma Deutschland differenziert analysiert. Die Ergebnisse sind repräsentativ für die angegebene Grundgesamtheit. Für die Berechnung regionaler Ergebnisse nutzt Civey Small-Area-Methoden mit einem Echtzeit- Modell. Dazu werden die Ergebnisse auf Basis einer modellbasierten, statistischen Methode für kleine Datenräume erhoben. Weitere Informationen und Ergebnisse finden Sie auf unserer Webseite. Der Pharma Deutschland e.V. ist der mitgliederstärkste Branchenverband der Pharmaindustrie in Deutschland. Er vertritt die Interessen von rund 400 https://www.pharmadeutschland.de/pharmawissen-fuer-alle/gesundheitsmonitor/ 3 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/

Badzura spricht von einer «totalen Planungsunsicherheit». Den meisten Praxen drohten Einnahmeverluste von 20 bis 30 Prozent. «Ich merke das auch bei meiner Arbeit mit Patient:innen. Ich möchte ihnen Sicherheit und Halt vermitteln, während mir von der Politik das Gegenteil vermittelt wird.» Es geht um das GKV-Beitragsstabilisierungsgesetz. «Was sich erst einmal vom Namen her schön anhört, weil es Stabilität suggeriert», sagt er in seiner Praxis in Offenbach. «Das Gegenteil ist aber der Fall. Aus meiner Sicht ist es einer der größten Eingriffe in die Versorgung und Vergütung der ambulanten Psychotherapie in Deutschland.» Worum geht es bei dem Gesetz? Der Begriff ist sperrig und damit auch das Thema: Konkret geht es um ein Gesundheits-Sparpaket der Bundesregierung. Es ist Ende Juli in Kraft getreten. Das Paket sieht Milliarden-Ausgabenbremsen bei Praxen, Kliniken, Apotheken und Pharmabranche vor - aber auch höhere Zuzahlungen und Einschnitte für Versicherte. Dies soll die gesetzlichen Krankenkassen im kommenden Jahr in Milliardenhöhe entlasten und neue Erhöhungen der Zusatzbeiträge verhindern. «Die Psychotherapie soll zurückgeführt werden in eine Budgetierung. In vereinfachten Worten bedeutet das, dass es pro Quartal eine festgelegte, gedeckelte Summe für die psychotherapeutische Versorgung geben wird, und wenn mehr Sitzungen pro Quartal geleistet werden, werden diese kaum oder gar nicht mehr vergütet», erklärt Badzura. Zudem würden die wichtigen Zuschläge für Kurzzeittherapien einfach gestrichen. «Das finden wir auch bezogen auf die Gesamtlage skandalös und es würde erhebliche Auswirkungen auf die Wartezeiten und die Versorgung gesetzlich Versicherter haben.» «Schon extrem lange Wartezeit von 140 Tagen für Therapieplatz» Er macht ein Beispiel: «Aktuell kann ein Therapeut mit halbem Kassensitz bis zu 28 Patient:innen in der Woche behandeln, und es wird darüber diskutiert, die Anzahl an voll vergüteten Sitzungen auf 18 zu reduzieren.» Badzura selbst hat einen halben Kassensitz. «Therapeut:innen müssen sich in der Folge nun wohl gut überlegen, ob Sie mehr als 18 gesetzlich Versicherten Therapieplätze anbieten, wo vorher 28 pro Woche einen Platz hatten. Dies ist bei einer jetzt schon extrem langen Wartezeit von 140 Tagen für einen Therapieplatz extrem besorgniserregend.» Laura Pacios Prado arbeitet in einer Privatpraxis in Frankfurt. «Ich merke, wie mich aktuell die Wut trägt, aber dahinter auch sehr viel Angst und Unsicherheit steckt», sagt sie. «Gerade ist meine Praxis gut ausgelastet, aber ich weiß nicht, ob das in einem halben Jahr so noch ist, da nun alle Privatpatienten behandeln wollen.» Das könne eine Folge des Gesetzes sein: Kollegen könnten, um ihre Praxis zu finanzieren, auf Privatpatienten ausweichen - was die Platzsuche für gesetzlich Versicherte weiter erschweren dürfte. «Ich habe einen Haufen gesetzliche Patienten, die sich bei mir melden, mehr gesetzliche Patienten als Privatpatienten», sagt Pacios Prado. «Und das zeigt ja schon, dass es bei Psychotherapeuten mit Kassensitz Schwierigkeiten gibt, einen Platz zu bekommen.» «Psychotherapie ist plötzlich Luxusgut» Für sie bedeutet das Gesetz eine Verschiebung der tatsächlichen Kosten in andere Sektoren, erklärt die Psychologische Psychotherapeutin. «Einmal in den privaten Sektor, weil Psychotherapie plötzlich Luxusgut ist. Nur noch einige haben Zugang dazu über die Kasse», sagt sie. «Das heißt, Privatpersonen müssen plötzlich für ihre psychische Gesundheit zahlen - neben den Kosten, die sie ja sowieso für die Versicherung zahlen.» Außerdem werde es mehr Kosten geben durch psychisch bedingte Arbeitslosigkeit, Frühverrentungen und längerer Arbeitsunfähigkeit. Und es gebe Folgen für die Patientinnen und Patienten. «Wir haben Einschränkung der Teilhabe etwa durch Depressionen. Die Leute ziehen sich zurück. Wir haben Bildungs- und Erwerbschancen, die einfach nicht ergriffen werden können, weil die Menschen psychisch erkranken», sagt Pacios Prado. «Hessen hat sich in Berlin für die Psychotherapie eingesetzt» Das hessische Gesundheitsministerium teilte auf Anfrage mit, die Sorgen der Patientinnen und Patienten sowie Therapeutinnen und Therapeuten ernst zu nehmen. «Hessen hat sich in Berlin für die Psychotherapie eingesetzt», hieß es. «Sie ist ein wichtiger Teil der medizinischen Versorgung und für viele Menschen unverzichtbar - gerade vor dem Hintergrund steigender Fallzahlen psychischer Erkrankungen und der teils langen Wartezeiten auf einen Therapieplatz.» Das Ministerium verweist auf Regelungen, die im parlamentarischen Verfahren zum Gesetz ergänzt worden seien. «So ist vorgesehen, dass bereits begonnene psychotherapeutische Behandlungen bis zu ihrem Abschluss weiterhin ohne Abzüge vergütet werden», heißt es. «Damit ist sichergestellt, dass Patientinnen und Patienten, die sich bereits in Therapie befinden, diese verlässlich fortführen können.» Die damalige Gesundheitsministerin Nina Warken (CDU) hatte Anfang Juli gesagt, die Reform sei nötig, denn mit der jetzigen Ausgabendynamik liefe es sonst über kurz oder lang auf einen «Systemkollaps» hinaus. Martin Badzura und Laura Pacios Prado sind enttäuscht von den Politikerinnen und Politikern. «Wir müssen uns fragen, ob unsere Gesellschaft das will», sagt Badzura. «Ob es in der Zukunft eine Zwei-Klassen-Gesellschaft bezogen auf Psychotherapie geben soll und Psychotherapie langfristig nur noch ein Luxusgut für Vermögende sein sollte.» Für Pacios Prado gibt es bloß eine Möglichkeit: «Wir müssen weiterhin laut sein», sagt sie. «Es ist keine Option, still zu sein und das alles mitzumachen. Ich bin besorgt um unsere Gesellschaft und um das System, darum, wie unsere Gesellschaft funktioniert.»

Die Europäische Kommission hat am 31. Juli 2026 den ersten Teil der Vorschläge für die jährliche Überarbeitung der Europäischen Nomenklatur für Medizinprodukte (European Medical Device Nomenclature, EMDN) veröffentlicht. Grundlage hierfür sind die zahlreichen Änderungsanträge, die Nutzerinnen und Nutzer bis zum 19. Februar 2026 über die öffentliche EMDN-Plattform eingereicht haben. Gemäß der MDCG-Leitlinie 2024-2 Rev. 1 „Procedures for the updates of the European Medical Device Nomenclature“ werden die eingegangenen Anträge im Rahmen eines mehrstufigen Verfahrens geprüft. Nach der technischen Bewertung erstellt das EMDN-Team einen Entwurf der vorgeschlagenen Änderungen, der anschließend der Nomenclature Working Group der Europäischen Kommission zur weiteren Prüfung vorgelegt wird. Aufgrund der hohen Zahl eingegangener Änderungsanträge hat die Kommission die Veröffentlichung der Vorschläge in zwei Teile aufgeteilt. Der erste Teil wurde am 31. Juli 2026 veröffentlicht, der zweite Teil soll am 31. August 2026 folgen. Die nun vorliegenden Vorschläge betreffen zahlreiche Produktgruppen und Bereiche der Medizintechnik. Dazu zählen unter anderem orthopädische Prothesen, chirurgische Instrumente, roboterchirurgische Hefter, Augenimplantate, neurovaskuläre Stents, Schulterprothesen, Insulin-Pen-Injektoren, Gehhilfen sowie verschiedene Verband- und Hilfsmittelkategorien. Darüber hinaus werden Änderungen für ausgewählte In-vitro-Diagnostika vorgeschlagen. Zur Unterstützung der fachlichen Bewertung hat die Europäische Kommission ein detailliertes Begleitdokument veröffentlicht. Dieses enthält für jeden Antrag eine Beschreibung des Analysegegenstands, die vorgenommenen Bewertungen sowie die vorgeschlagenen Ergebnisse. Besonderes Interesse seitens der Kommission besteht an den Anträgen zu roboterchirurgischen Heftern (IDs 62_2026 bis 67_2026), für die jeweils zwei alternative Lösungsansätze vorgestellt werden. Die Kommission bittet hierzu ausdrücklich um Rückmeldungen. Zusätzlich wurde eine neue Excel-Arbeitsmappe veröffentlicht, in der die vorgeschlagenen Änderungen bereits in die vollständige EMDN-Struktur integriert sind. Sie enthält neben der aktuellen EMDN-Version 2026 einen Entwurf der möglichen EMDN-Version 2027 und ermöglicht damit einen ersten Überblick über die künftige Nomenklatur. Ergänzt wird dies durch eine weitere Datei mit detaillierten Informationen zu den in die Analyse einbezogenen Anträgen. Pharma Deutschland wird die Rückmeldungen seiner Mitgliedsunternehmen bündeln und diese über die AESGP an die Europäische Kommission weiterleiten. Unternehmen, die Anmerkungen zu den veröffentlichten Änderungsvorschlägen haben, werden gebeten, die bereitgestellte Kommentartabelle auszufüllen und ihre Stellungnahme bis zum 20. August 2026 an Marie Anton ( anton@pharmadeutschland.de ) zu übermitteln.

2026 annual revision: submissions analysis and outcome overview_Batch1 (rev01, 31st July 2026) Summary ID 1588 - ORTHOPAEDIC PROSTHESES: Osseointegrated implant for amputated patients 8 REQUESTS DETAILS 8 DESCRIPTION OF DEVICE 8 OUTCOME 11 ID 26_2026; ID 27_2026 - ORTHOPAEDIC PROSTHESES: Knee Prostheses 13 REQUESTS DETAILS 13 DESCRIPTION OF DEVICE 15 OUTCOME 15 ID 1575, ID 1576, ID 1577, ID 1578, ID 1579, ID 1580, ID 1581, ID 1582, ID 1583, ID 1584, ID 1585, ID 1586 – ORTHOPAEDIC SURGICAL INSTRUMENTS 17 REQUESTS DETAILS 17 DESCRIPTION OF DEVICE 21 OUTCOME 22 NOT ACCEPTED 22  ID 1579 (INSERT Z12139010 - ORTHOPAEDIC SURGERY TEMPLATES); ID 1581 (INSERT Z12139009 - ORTHOPAEDIC SURGERY CHECK GAUGE) 22  ID 1585 (INSERT Z12139007 - ORTHOPAEDIC TRIAL IMPLANTS) 23 OUTCOME: PARTIALLY ACCEPTED 24  ID 1575 (INSERT L0929 - ORTHOPEDIC SURGERY AND TRAUMATOLOGICAL IMPACTORS, REUSABLE); ID 1578 (INSERT L0933- ORTHOPEDIC IMPLANT/INSTRUMENT ASSEMBLING DEVICE, REUSABLE); 1582 (INSERT Z12139008 - ORTHOPAEDIC SURGERY PINS) 24  ID 1576 (INSERT L0930- ORTHOPEDIC SURGERY HANDLES, REUSABLE) 24  ID 1577 (INSERT L0932 - ORTHOPAEDIC BONE PREPARATION PROTECTOR, REUSABLE) 25  ID 1580 (INSERT L091107- ORTHOPAEDIC PROSTHESES BENDER, REUSABLE) 25  ID 1583 (INSERT L0935- ORTHOPAEDIC SURGERY PUNCHES, REUSABLE) 25  ID 1584 - ID 1586 (duplication) (INSERT L0936- ORTHOPAEDIC SURGERY AWLS, REUSABLE) 25 ID 1596; ID 1597; ID 1598; ID 1599; ID 1600, ID 1601; ID 1602; ID 1603; ID 1604; ID 1605, ID 1606 - SURGERY INSTRUMENTS, REUSABLE 29 REQUESTS DETAILS 29 DESCRIPTION OF DEVICES 30 OUTCOME 30 OUTCOME: NOT ACCEPTED 31  ID 1597 ( INSERT L0320 - TRIAL IMPLANTS) 31  ID 1604 (INSERT L0325 - SURGICAL IMPLANT TEMPLATE, REUSABLE) 31 OUTCOME: PARTIALLY ACCEPTED 32  ID 1596 (INSERT L0319 - IMPLANT INSERTERS) 32  ID 1598 (INSERT L0321 - SURGICAL CHISELS) 32  ID 1599 (INSERT L0322 - SURGICAL RONGEURS) 33  ID 1600 ( INSERT L0928 - MANUAL ORTHOPAEDIC BENDERS, REUSABLE) 33  ID 1601 (INSERT L0323 - SURGICAL INSTRUMENT HANDLES) 33  ID 1602 (INSERT L0324 - SURGICAL HAND DRILLS) 33  ID 1603 (INSERT L0325 - SURGICAL ALIGNMENT TOOL) 34  ID 1605 (INSERT L0326 - BONE AWL, REUSABLE) 34  ID 1606 (INSERT L090904 - ORTHOPAEDIC IMPLANTABLE-DEVICE CUTTER) 34 PROPOSAL (ID 1596 – 1598 – 1599 – 1600 – 1601 – 1602 – 1603 – 1605 – 1606) 35 ID 62_2026, ID 63_2026, ID 64_2026, ID 65_2026, ID 66_2026, ID 67_2026 – ROBOTIC SURGERY STAPLERS 37 REQUESTS DETAILS 37 DESCRIPTION OF DEVICE 38 OUTCOME 39 ID 1568 - RESPIRATORY THERAPY AIDS 43 REQUESTS DETAILS 43 DESCRIPTION OF DEVICE 44 OUTCOME 44 ID 1540 - URINALS 45 REQUESTS DETAILS 45 DESCRIPTION OF DEVICE 46 OUTCOME 46 ID 37_2026 - INSULIN PEN INJECTORS 47 REQUESTS DETAILS 47 DESCRIPTION OF DEVICE 48 OUTCOME 48 ID 53_2026 - BLOOD HEATERS FOR DIALYSIS 49 REQUESTS DETAILS 49 DESCRIPTION OF DEVICE 50 OUTCOME 50 ID 1559, ID 1607, ID 48_2026 - OCULAR IMPLANTS 51 REQUESTS DETAILS 51 DESCRIPTION OF DEVICES 54  ID 1559 (INSERT Q0212 CILIO-SCLERAL INTERPOSITION DEVICE) 54  ID 1607 (INSERT P0302 - NON-OPTICAL ENDOCAPSULAR DEVICES, P030201 - OPEN-CAPSULE ENDOCAPSULAR DEVICES, P030202 - CAPSULAR TENSION RINGS (CTRS)) 54  ID 48_2026 (NEW P03XX - RING (OPHTALMOLOGY)) 55 OUTCOME 55  ID 1559 (INSERT Q0212 CILIO-SCLERAL INTERPOSITION DEVICE) 55  1607 (INSERT P0302 - NON-OPTICAL ENDOCAPSULAR DEVICES, P030201 - OPEN-CAPSULE ENDOCAPSULAR DEVICES, P030202 - CAPSULAR TENSION RINGS (CTRS)) 55  ID 48_2026 (NEW P03XX - RING (OPHTALMOLOGY)) 56  ADDITIONAL PROPOSALS COMING FROM DATABASE ANALYSIS 56 ID 16_2026, ID 17_2026, ID 18_2026 - PARASITOLOGY IMMUNOASSAY 57 REQUESTS DETAILS 57 DESCRIPTION OF DEVICE 58  ID 16_2026 (INSERT W0105050211 - Trichinella spiralis) 58  ID 17_2026 (INSERT W0105050212 - Taeniasis / cysticercosis) 58  ID 18_2026 (INSERT W0105050213 - Toxocara canis) 58 OUTCOME 58  ID 16_2026 (INSERT W0105050211 - Trichinella spiralis) 58  ID 17_2026 (INSERT W0105050212 - Taeniasis / cysticercosis) 59  ID 18_2026 (INSERT W0105050213 - Toxocara canis) 59 ADDITIONAL PROPOSALS COMING FROM DATABASE ANALYSIS 59 ID 1535 - WALKING AIDS 60 REQUESTS DETAILS 60 DESCRIPTION OF DEVICE 61 OUTCOME 61 ADDITIONAL PROPOSALS COMING FROM DATABASE ANALYSIS 61 ID 1550 - SIGNALLING AIDS 62 REQUESTS DETAILS 62 DESCRIPTION OF DEVICE 63 OUTCOME 63 ADDITIONAL PROPOSALS COMING FROM DATABASE ANALYSIS 63 ID 1543, ID 1544, ID 1547 – BED AND WHEELCHAIR MOBILITY RESTRAINT 64 REQUESTS DETAILS 64 DESCRIPTION OF DEVICE 65 OUTCOME 66 ID 1545 – ARM SUPPORT SLINGS 67 REQUESTS DETAILS 67 DESCRIPTION OF DEVICE 67 OUTCOME 68 ID 1548 – ANTI-SLIP SYSTEMS 68 REQUESTS DETAILS 68 DESCRIPTION OF DEVICE 69 OUTCOME 69 ID 1574, ID 32_2026 - NEUROVASCULAR STENTS 70 REQUESTS DETAILS 70  ID 1574 (INSERT P07040203-NEUROVASCULAR STENTS) 71  ID 32_2026 (INSERT P07040203 - INTRACRANIAL VASCULAR STENT) 71 DESCRIPTION OF DEVICE 71  ID 1574 (INSERT P07040203-NEUROVASCULAR STENTS) 71  ID 32_2026 (INSERT P07040203 - INTRACRANIAL VASCULAR STENT) 72 OUTCOME 72  ID 1574 (INSERT P07040203-NEUROVASCULAR STENTS) 72  ID 32_2026 (INSERT P07040203 - INTRACRANIAL VASCULAR STENT) 72  ADDITIONAL PROPOSAL COMING FROM EVALUATIONS 72 ID 25_2026 – STERNAL PROSTHESES 74 REQUESTS DETAILS 74 DESCRIPTION OF DEVICE 75 OUTCOME 76 PROPOSAL 76 ID 1590 - DRILL ATTACHMENTS 77 REQUESTS DETAILS 77 DESCRIPTION OF DEVICE 78 OUTCOME 78 ID 1610 - DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS (Polymeric Membrane Dressings) 79 REQUESTS DETAILS 79 DESCRIPTION OF DEVICE 80 OUTCOME 81 ID 23_2026 - INTRAMEDULLARY NAILS FOR LIMB LENGTHENING 83 REQUESTS DETAILS 83 DESCRIPTION OF DEVICE 84 OUTCOME 84 ID 1592, 1593, 1594 – SHOULDER PROSTHESES 86 REQUESTS DETAILS 86 DESCRIPTION OF DEVICE 88 OUTCOME 88 ID 33_2026 – MOBILITY RESTRAINT SYSTEMS 91 REQUESTS DETAILS 91 DESCRIPTION OF DEVICE 92 OUTCOME 92 ID 1570, ID 1571, ID 1572 – SINGLE-USE NON-SPECIALIST SURGICAL INSTRUMENTS 92 REQUESTS DETAILS 92 DESCRIPTION OF DEVICE 94 OUTCOME 94  ID 1570 (INSERT V93- MEDICAL DEVICES FOR GENERAL SURGERY-SINGLE USE (TWEEZERS)) 94  ID 1571 (INSERT V93- MEDICAL DEVICES FOR GENERAL SURGERY, SINGLE USE (RETRACTORS)) 95  ID 1572 (INSERT V93- MEDICAL DEVICES FOR GENERAL SURGERY, SINGLE USE (CURETTE)) 95  ADDITIONAL PROPOSAL COMING FROM EVALUATIONS 95 ID 30_2026 - INTRACARDIAC IMPLANT FOR ATRIAL SHUNT 97 REQUESTS DETAILS 97 DESCRIPTION OF DEVICE 98 OUTCOME 98 [bookmark: _Toc661393866][bookmark: _Toc236388328]ID 1588 - ORTHOPAEDIC PROSTHESES: Osseointegrated implant for amputated patients [bookmark: _Toc109365612][bookmark: _Toc236388329]REQUESTS DETAILS ID EMDN \Category EMDN Code or Reference Type of update Proposal (specify Code XXX – Term XXX) Supporting information 1588 P P0999 INSERT  P0914-OSSEOINTEGRATED ORTHOPAEDIC DISTAL FEMORAL IMPLANT   There is no existing code that corresponds to the type of distally loaded osseointegrated implant for patients with amputation, and it is not adequately represented by the name assigned within the existing EMDN codes; INTENDED PURPOSE: The foreseen functionality of the implant is permitting the indicated patients the usage of distal weight bearing socket, diminishing in this manner the uncomfortable ischium charge of existing ischium support sockets, permitting to take maximum advantage of the performances of a distal socket without any proximal hindrances. Anchoring or fixation of the implant in the medullar canal of the residual femur will be performed by means of an intra-medullar stem that can be impacted or cemented. In the case of the press-fit technique, stem osseointegration with the surrounding bone tissue will take place. Additional Information received attached or sent upon request · Request attachments: IFU, device description document; [bookmark: _Toc610456323][bookmark: _Toc236388330]DESCRIPTION OF DEVICE The femoral implant in analysis scope is to enable distal loading of the residual limb, allowing patients with transfemoral amputations to achieve the same level of functionality as patients with knee disarticulation amputations. From the technical documentation: “It is well documented in the literature that patients with a disarticulated knee have superior functionality compared to transfemoral patients due to the difference in support level. Without the implant, transfemoral amputees can only support themselves proximally on the ischium, which is the only point of support. This causes them much discomfort and has biological repercussions on the femoral residue due to the loss of mechanical stimulus in the bone. The femoral implant enables loads from the prosthetic leg to be transmitted directly to the residual femur, instead of being supported by the soft tissues of the thigh, which can cause inconveniences such as wounds and skin tenderness. The femoral implant actuates as an intermediary between the natural bone structure and the artificial structure of the external prosthesis and allows the sensorial perception by the patient, called Osseo perception or bone perception, which helps the patient to know where to place the prosthesis while ambulating. To better understand the operational principle of the femoral implant, it’s important to be aware that unlike individuals with a knee disarticulation (Figure 2), a person with a transfemoral amputation can no longer take the body's weight directly on the transected end of the limb and the body weight when wearing an external prosthetic leg, has to be supported by the ischium and surrounding thigh muscles through the use of an ischium support socket (Figure 3).” [image: ] “The foreseen functionality of the implant is permitting the indicated patients the usage of distal weight bearing socket, diminishing in this manner the uncomfortable ischium charge of existing ischium support sockets, permitting to take maximum advantage of the performances of a distal socket without any proximal hindrances. Anchoring or fixation of the implant in the medullar canal of the residual femur will be performed by means of an intra-medullar stem that can be impacted or cemented. In the case of the press-fit technique, stem osseointegration with the surrounding bone tissue will take place.” [image: ] The components of the system under analysis are inherently designed to provide stump support. The Femoral Implant allows patients undergoing or who have undergone a transfemoral amputation to use an external distal-loading prosthesis, thereby reducing the discomfort associated with the ischial loading of conventional prostheses. Fixation of the implant within the medullary canal of the residual femur is achieved using an intramedullary stem, which can be either press-fitted (impacted) or cemented. [image: ] [bookmark: _Toc1375160974][bookmark: _Toc236388331]OUTCOME PARTIALLY ACCEPTED While we recognize the need for a new classification level dedicated to implantable devices for amputated limbs, the proposed designation "P0914 - Osseointegrated Orthopaedic Distal Femoral Implant" is technically inappropriate. Osseointegration is strictly defined as: “the direct anchorage of a metal implant into bone, allowing for the connection of an external prosthesis to the skeleton.” The device under analysis does not provide a direct connection to an external prosthesis; instead, it is an intramedullary femoral implant designed to enable distal load management entirely internal to the amputated limb. Properly defined osseointegrated systems typically consist of two main components: an internal implanted portion and an external prosthesis connected. This allows for a direct connection to the femoral implant through an abutment. Our analysis highlighted a gap regarding the classification level for these devices as well. In the current nomenclature, the only available code is "Y062415 - Transfemoral prostheses (for amputation above knee)", which should be used exclusively for registering the external prosthesis of both distal weight-bearing prostheses and osseointegrated systems. Therefore, we propose creating a new section for orthopedic implants dedicated to amputated limbs under Category P (Implantable Prosthetic Devices), subdivided into two distinct levels: · Distal weight-bearing intramedullary implants / Impianti intramidollari per il carico distale · Osseointegrated systems / Sistemi osteointegrati In addition, we propose the creation of a dedicated level for accessories to allow for the proper registration of any related components of these systems. PROPOSAL CODE LEVEL TERMINAL LEVEL (YES/NO) TERM DESCRIZIONE P09 2 NO ORTHOPAEDIC PROSTHESES, OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS PROTESI ORTOPEDICHE E MEZZI PER OSTEOSINTESI E SINTESI TENDINEO-LEGAMENTOSA … … … … … P0901 3 NO SHOULDER PROSTHESES PROTESI DI SPALLA … … … … … P0902 3 NO ELBOW PROSTHESES PROTESI DI GOMITO … … … … … P0903 3 NO WRIST PROSTHESES PROTESI DI POLSO … … … … … P0904 3 NO HAND PROSTHESES PROTESI DI MANO … … … … … P0905 3 NO ANKLE PROSTHESES PROTESI DI CAVIGLIA … … … … … P0906 3 NO FOOT PROSTHESES PROTESI DI PIEDE … … … … … P0907 3 NO SPINE STABILISATION PROSTHESES AND SYSTEMS PROTESI E SISTEMI DI STABILIZZAZIONE DELLA COLONNA VERTEBRALE … … … … … P0908 3 NO HIP PROSTHESES PROTESI DI ANCA … … … … … P0909 3 NO KNEE PROSTHESES PROTESI DI GINOCCHIO … … … … … P0910 3 YES LIGAMENT PROSTHESES PROTESI LIGAMENTOSE … … … … … P0912 3 NO OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS MEZZI PER OSTEOSINTESI E SINTESI TENDINEO-LEGAMENTOSA … … … … … P0913 3 NO ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE STRUMENTARIO PER PROTESICA ORTOPEDICA, MONOUSO … … … … … P0914 3 NO INTRAMEDULLARY IMPLANTABLE SYSTEMS FOR RESIDUAL LIMBS SISTEMI INTRAMIDOLLARI IMPIANTABILI PER MONCONI DI ARTI P091401 4 YES INTRAMEDULLARY IMPLANTABLE SYSTEMS FOR DISTAL RESIDUAL LIMB LOADING SISTEMI IMPIANTABILI INTRAMIDOLLARI PER IL CARICO DISTALE DEL MONCONE P091402 4 YES OSSEOINTEGRATED SYSTEMS FOR PERCUTANEOUS PROSTHETIC CONNECTION SISTEMI OSSEOINTEGRATI PER CONNESSIONE PROTESICA PERCUTANEA P091480 4 YES INTRAMEDULLARY IMPLANTABLE SYSTEMS FOR RESIDUAL LIMBS - ACCESSORY SISTEMI INTRAMIDOLLARI IMPIANTABILI PER MONCONI DI ARTI - ACCESSORI P0990 3 NO ORTHOPAEDIC PROSTHESES - VARIOUS PROTESI ORTOPEDICHE - VARIE … … … … … P0999 3 YES ORTHOPAEDIC PROSTHESES, OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - OTHER PROTESI ORTOPEDICHE E MEZZI PER OSTEOSINTESI E SINTESI TENDINEO-LEGAMENTOSA - ALTRI [bookmark: _Toc506496238] [bookmark: _Toc236388332]ID 26_2026; ID 27_2026 - ORTHOPAEDIC PROSTHESES: Knee Prostheses [bookmark: _Toc234244839][bookmark: _Toc592458857][bookmark: _Toc236388333]REQUESTS DETAILS ID EMDN \Category- EMDN Code or Reference Type of update Proposal (specify Code XXX – Term XXX) Supporting information 26_2026 P P090905: Revision knee prostheses INSERT  P09090503 - HINGE KNEE Hinge knee are used as revision knee prostheses (P090905, the nearest code), but there is no specific EMDN code for this type of device in this group. The conception of hinge knee is different from the one used for TKA (total knee arthroplasty) and population is usually different. So a EMDN specific to that case should be added 27_2026  P  P090999: Knee prostheses - other INSERT  P090909 - MODULAR KNEE Modular knee are a type of knee prostheses, but there is no EMDN code for this type of device. The population and conception of this kind of prothesis id different frome the hinge one and the one for TKA and concern a specific population with a important bone defect [bookmark: _Toc234244840]Additional Information received attached or sent upon request · Additional information provided upon request: Category Details Medical Domain Orthopedics, Knee Replacement Surgery Indication Used in complex primary and revision knee arthroplasty, especially in cases of ligamentous insufficiency, severe deformity, or bone loss. Description Hinge knee prostheses provide a rotating or fixed hinge mechanism to stabilize the knee joint, allowing controlled motion and weight-bearing. Materials Cobalt-chromium alloy, titanium, ultra-high-molecular-weight polyethylene (UHMWPE). Commercial Names NexGen® Rotating Hinge Knee (Zimmer Biomet), Endo-Model® (WALDEMAR LINK), LEGION HK (Smith+Nephew), Triathlon Hinge Knee (Stryker). Category Details Medical Domain Orthopedics, Knee Replacement Surgery Indication Used in primary and revision knee arthroplasty to address various levels of bone loss and ligament instability. Description Modular knee systems offer a range of components and augments to customize the fit and function for each patient’s anatomy and surgical requirements. Materials Cobalt-chromium alloy, titanium, ultra-high-molecular-weight polyethylene (UHMWPE). Commercial Names LEGION Modular Knee System (Smith+Nephew), Triathlon Modular Knee (Stryker), Endo-Model Modular (WALDEMAR LINK). [image: ][image: ] [bookmark: _Toc379155546][bookmark: _Toc236388334]DESCRIPTION OF DEVICE · 26_2027: The request is to create a dedicated level for Hinge prostheses, which are highly constrained systems featuring a mechanical linkage. These devices are utilized in both complex primary and revision total knee replacements (TKR). [image: ] · 27_2026: The request is to create a dedicated level for Modular knee prostheses. [bookmark: _Toc234244843][bookmark: _Toc1493585792][bookmark: _Toc236388335]OUTCOME NOT ACCEPTED · 26_2026: There is no evidence supporting the need for an update regarding hinge knee prostheses and the only feasible solution to address this overlap would be a structural reorganization of the EMDN based on biomechanics or constraint levels (e.g., creating a dedicated "Hinge" category). However, such a change is currently deemed too impactful. It would require a massive restructuring of the nomenclature, effectively eliminating the current subdivision into "Primary" and "Revision". · 27_2026: The request for a dedicated level for modular prostheses is not supported by the technical evaluation. For regulatory and safety reasons, the EMDN code must accurately represent the device as it is placed on the market; currently, knee systems are already registered as individual components. Furthermore, any additional modular elements, such as stems or augments, are already covered under existing levels within the 80-Accessories section. TYPE OF REQUEST CODE SUPPORT INFO RATIONALE EXTENDED RATIONALE INSERT P090905: Revision knee prostheses Hinge knee are used as revision knee prostheses (P090905, the nearest code), but there is no specific EMDN code for this type of device in this group. The conception of hinge knee is different from the one used for TKA (total knee arthroplasty) and population is usually different. So a EMDN specific to that case should be added. The insertion of a new term is aimed at include types of devices not present in the current version of the EMDN. If necessary, multiple codes can be assigned to the same UDI-DI. The creation of a specific section for Hinge prostheses would require a structural reorganization of the EMDN based on biomechanics or constraint eliminating the current subdivision into "Primary" and "Revision" prostheses. Such a change would require a massive restructuring of the nomenclature. INSERT P090999: Knee prostheses - other Modular knee are a type of knee prostheses, but there is no EMDN code for this type of device.The population and conception of this kind of prothesis id different frome the hinge one and the one for TKA and concern a specific population with a important bone defect The insertion of a new term is aimed at include types of devices not present in the current version of the EMDN. If necessary, multiple codes can be assigned to the same UDI-DI. The technical evaluation does not support the need for an update. For safety and regulatory accuracy, EMDN codes must reflect how devices are placed on the market, where knee systems are already registered as individual components. Additional modular parts are already covered under 80-Accessories [bookmark: _Toc162687190][bookmark: _Toc236388336]ID 1575, ID 1576, ID 1577, ID 1578, ID 1579, ID 1580, ID 1581, ID 1582, ID 1583, ID 1584, ID 1585, ID 1586 – ORTHOPAEDIC SURGICAL INSTRUMENTS [bookmark: _Toc1648907675][bookmark: _Toc236388337]REQUESTS DETAILS ID EMDN \Category- EMDN Code or Reference Type of update Proposal (specify Code XXX – Term XXX) Supporting information 1575 L L09 INSERT L0929 - Orthopedic surgery and traumatological impactors, reusable reason of change: A review of the currently existing EMDN codes shows that none accurately reflect the characteristics and intended use of the device. This intended use applies to impactors, for which the existing code L091104 (orthopaedic prosthesis positioners, reusable) is not appropriate. Using an existing but inaccurate code could lead to misclassification and confusion regarding the device’s actual function, clinical use, and regulatory requirements. Therefore, a new specific code is necessary to ensure clarity and consistency in classification. intended use: A manual reusable surgical instrument used to position an implant and trial implant into the body via an impact force. 1576 L L09 INSERT [bookmark: _Hlk233962012]L0930- Orthopedic surgery handles, reusable reason of change: A review of the currently existing EMDN codes shows that none accurately reflect the characteristics and intended use of the device. This intended use applies to handles, for which no existing code is appropriate. Using an existing but inaccurate code could lead to misclassification and confusion regarding the device’s actual function, clinical use, and regulatory requirements. Therefore, a new specific code is necessary to ensure clarity and consistency in classification. intended use: A manual reusable surgical instrument. It is designed to be attached to the proximal end of a surgical instrument to allow the surgeon to perform manipulations with the instrument, such as rotation of a bone screw or reamer. 1577 L L INSERT L0932 - Orthopaedic bone preparation protector, reusable reason of change: A review of the currently existing EMDN codes shows that none accurately reflect the characteristics and intended use of the device. This intended use applies to bone preparation protection plate , for which no existing code is appropriate. Using an existing but inaccurate code could lead to misclassification and confusion regarding the device’s actual function, clinical use, and regulatory requirements. Therefore, a new specific code is necessary to ensure clarity and consistency in classification. intended use: A reusable instrument designed to protect the resection of a bone structure during the preparation of the bone. 1578 L L09 INSERT L0933- Orthopedic implant/instrument assembling device, reusable reason of change: A review of the currently existing EMDN codes shows that none accurately reflect the characteristics and intended use of the device. This intended use applies to bone preparation protection plate , for which no existing code is appropriate. Using an existing but inaccurate code could lead to misclassification and confusion regarding the device’s actual function, clinical use, and regulatory requirements. Therefore, a new specific code is necessary to ensure clarity and consistency in classification. intended use: A reusable instrument designed to protect the resection of a bone structure during the preparation of the bone. 1579 Z Z121390 INSERT Z12139010 - Orthopaedic surgery templates reason of change: A review of the currently existing EMDN codes shows that none accurately reflect the characteristics and intended use of the device. This intended use applies to sterile templates, for which the existing code L0922 (orthopaedic surgery guides, reusable) is not appropriate.Using the existing but inaccurate code could lead to misclassification and confusion regarding the device’s actual function, clinical use, and regulatory requirements. Therefore, a new specific code is necessary to ensure clarity and consistency in classification. intended use: A surgical instrument designed to determine the appropriate size and placement of an implant for a patient during implantation surgery. 1580 L L0911 INSERT L091107- Orthopaedic protheses bender, reusable reason of change: A review of the currently existing EMDN codes shows that none accurately reflect the characteristics and intended use of the device. This intended use applies to bending instruments, for which no existing code is appropriate.Using an existing but inaccurate code could lead to misclassification and confusion regarding the device’s actual function, clinical use, and regulatory requirements. Therefore, a new specific code is necessary to ensure clarity and consistency in classification. intended use: A reusable manually operated surgical instrument designed to bend orthopaedic devices to an appropriate anatomical shape. 1581 Z Z121390 INSERT Z12139009 - Orthopaedic surgery check gauge reason of change: A review of the currently existing EMDN codes shows that none accurately reflect the characteristics and intended use of the device. This intended use applies to steril deph finder and gap joint testers, for which no existing code is appropriate. Using an existing but inaccurate code could lead to misclassification and confusion regarding the device’s actual function, clinical use, and regulatory requirements. Therefore, a new specific code is necessary to ensure clarity and consistency in classification. intended use: A surgical instrument for examining certain joint properties during orthopaedic surgery, e.g. checking ligament tension in the joint gap. 1582 Z Z121390 INSERT Z12139008 - Orthopaedic surgery pins reason of change: A review of the currently existing EMDN codes shows that none accurately reflect the characteristics and intended use of the device. This intended use applies to sterile pins, for which the existing code L0922 (orthopaedic surgery guides, reusable) is not appropriate. Using an existing but inaccurate code could lead to misclassification and confusion regarding the device’s actual function, clinical use, and regulatory requirements. Therefore, a new specific code is necessary to ensure clarity and consistency in classification. intended use: A surgical instrument designed to facilitate the correct orientation of an orthopaedic implant or instrument during orthopaedic surgery. 1583 L L09 INSERT L0935- Orthopaedic surgery punches, reusable reason of change: A review of the currently existing EMDN codes shows that none accurately reflect the characteristics and intended use of the device. This intended use applies to punches, for which no existing code is appropriate. Using an existing but inaccurate code could lead to misclassification and confusion regarding the device’s actual function, clinical use, and regulatory requirements. Therefore, a new specific code is necessary to ensure clarity and consistency in classification. intended use: A hand-held manual reusable surgical instrument designed to densify or grind bone tissue. [bookmark: _Hlk234244454]1584 L L09 INSERT L0936- Orthopaedic surgery awls, reusable reason of change: A review of the currently existing EMDN codes shows that none accurately reflect the characteristics and intended use of the device. This intended use applies to awls, for which the existing codes L091102 (orthopaedic prostheses reamers ans burs, reusable) and L091201 (orthopaedic surgery rasps, reusable) are not appropriate. Using the existing but inaccurate codes could lead to misclassification and confusion regarding the device’s actual function, clinical use, and regulatory requirements. Therefore, a new specific code is necessary to ensure clarity and consistency in classification. intended use: A reusable spike-like, surgical instrument with a handle that is used manually to bore holes in the bone and e.g. to open and enlarge the medullary cavity. 1585 Z Z121390 INSERT Z12139007 - Orthopaedic trial impants A review of the currently existing EMDN codes shows that none accurately reflect the characteristics and intended use of the device. This intended use applies to sterile trial, for which no existing code is appropriate. Using an existing but inaccurate code could lead to misclassification and confusion regarding the device’s actual function, clinical use, and regulatory requirements. Therefore, a new specific code is necessary to ensure clarity and consistency in classification. intended use: A sugical instrument, designed as a copy of a final prosthetic implant or component, used to determine the correct alignment, size, and fit of the final prosthesis. 1586 L L09 INSERT L0936- Orthopaedic surgery awls, reusable A review of the currently existing EMDN codes shows that none accurately reflect the characteristics and intended use of the device. This intended use applies to awls, for which the existing codes L091102 (orthopaedic prostheses reamers ans burs, reusable) and L091201 (orthopaedic surgery rasps, reusable) are not appropriate. Using the existing but inaccurate codes could lead to misclassification and confusion regarding the device’s actual function, clinical use, and regulatory requirements. Therefore, a new specific code is necessary to ensure clarity and consistency in classification. intended use: A reusable spike-like, surgical instrument with a handle that is used manually to bore holes in the bone and e.g. to open and enlarge the medullary cavity. Additional Information received attached or sent upon request · Surgical Technique, declaration of conformity, IFU [bookmark: _Toc1499552659][bookmark: _Toc236388338]DESCRIPTION OF DEVICE · 1575 (INSERT L0929 - ORTHOPEDIC SURGERY AND TRAUMATOLOGICAL IMPACTORS, REUSABLE); 1578 (INSERT L0933- ORTHOPEDIC IMPLANT/INSTRUMENT ASSEMBLING DEVICE, REUSABLE); 1582 (INSERT Z12139008 - ORTHOPAEDIC SURGERY PINS): These devices are manual, reusable surgical instruments used during the preparation and implantation phases of orthopaedic surgery. They include impactors, designed to transmit force (typically from a mallet) to drive or position an implant or trial into the bone; assembling tools, such as head assembly presses, used to combine modular prosthetic components intraoperatively; and alignment pins, used to facilitate and verify the correct anatomical orientation of an implant or instrument. · 1576 (INSERT L0930- ORTHOPEDIC SURGERY HANDLES, REUSABLE): These are manual, reusable instruments designed to be attached to the proximal end of surgical tools (such as screw drivers, reamers, or broaches) to allow the surgeon to perform rotations and other manual manipulations. They often feature ergonomic T-shaped or straight grips and may incorporate a mandrel-type locking mechanism to secure interchangeable instrument attachments. · 1577 (INSERT L0932 - ORTHOPAEDIC BONE PREPARATION PROTECTOR, REUSABLE): These are manual, reusable instruments designed to protect specific anatomical structures during surgery. Examples include resection protection plates or caps (available in various angles and sizes) used to shield bone structures (like the humerus) or soft tissues while other preparations are being conducted. · 1579 (INSERT Z12139010 - ORTHOPAEDIC SURGERY TEMPLATES); 1581 (INSERT Z12139009 - ORTHOPAEDIC SURGERY CHECK GAUGE); - REJECTED REQUESTS: These requests covered manual surgical templates used to determine implant size and placement; in particular, check/depth gauges are used to measure drill holes or joint properties (like ligament tension). · 1580 (INSERT L091107- ORTHOPAEDIC PROSTHESES BENDER, REUSABLE): This device is a manually operated, reusable surgical instrument designed to bend or contour orthopaedic implants, such as rods or plates, to match a patient's specific anatomical shape intraoperatively. · 1583 (INSERT L0935- ORTHOPAEDIC SURGERY PUNCHES, REUSABLE): These are hand-held, manual, reusable instruments designed to densify, grind, or core bone tissue. They typically feature a handle and a distal tip with a bevelled, sharp cutting edge that is rotated or pressed to penetrate and remove bone sections. · 1584 & 1586 (duplication) (INSERT L0936- ORTHOPAEDIC SURGERY AWLS, REUSABLE): These are spike-like, manual, reusable instruments featuring a sharp point and an ergonomic handle. They are used to manually bore holes in bone or to open and enlarge the medullary cavity. · 1585 (INSERT Z12139007 - ORTHOPAEDIC TRIAL IMPLANTS): These devices are copy-replicas of final prostheses used to verify fit before final implantation. [bookmark: _Toc1054011862][bookmark: _Toc236388339]OUTCOME [bookmark: _Toc115039154][bookmark: _Toc236388340]NOT ACCEPTED · [bookmark: _Toc236388341]ID 1579 (INSERT Z12139010 - ORTHOPAEDIC SURGERY TEMPLATES); ID 1581 (INSERT Z12139009 - ORTHOPAEDIC SURGERY CHECK GAUGE) TYPE OF REQUEST CODE SUPPORT INFO RATIONALE EXTENDED RATIONALE INSERT Z12139010 - ORTHOPAEDIC SURGERY TEMPLATES reason of change: A review of the currently existing EMDN codes shows that none accurately reflect the characteristics and intended use of the device. This intended use applies to sterile templates, for which the existing code L0922 (orthopaedic surgery guides, reusable) is not appropriate. Using the existing but inaccurate code could lead to misclassification and confusion regarding the device’s actual function, clinical use, and regulatory requirements. Therefore, a new specific code is necessary to ensure clarity and consistency in classification. intended use: A surgical instrument designed to determine the appropriate size and placement of an implant for a patient during implantation surgery. The inclusion of new levels is planned to include types of devices not present in the current version of the EMDN (refer to L0923 ORTHOPAEDICS SURGICAL MEASURERS, REUSABLE) From a functional standpoint, these devices are classified as surgical measuring instruments, which are already technically covered by the existing code L0923 (ORTHOPAEDICS SURGICAL MEASURERS, REUSABLE). Consequently, the creation of a new, specific code was considered unnecessary. INSERT Z12139009 - ORTHOPAEDIC SURGERY CHECK GAUGE reason of change: A review of the currently existing EMDN codes shows that none accurately reflect the characteristics and intended use of the device. This intended use applies to steril deph finder and gap joint testers, for which no existing code is appropriate. Using an existing but inaccurate code could lead to misclassification and confusion regarding the device’s actual function, clinical use, and regulatory requirements. Therefore, a new specific code is necessary to ensure clarity and consistency in classification. intended use: A surgical instrument for examining certain joint properties during orthopaedic surgery, e.g. checking ligament tension in the joint gap. The inclusion of new levels is planned to include types of devices not present in the current version of the EMDN (refer to L0923 ORTHOPAEDICS SURGICAL MEASURERS, REUSABLE) The analysis confirmed that depth gauges fall within the definition of surgical measuring instruments already covered by level L0923. Since the device's function is already mapped to a specific level, the request for a new code was rejected. · [bookmark: _Toc236388342]ID 1585 (INSERT Z12139007 - ORTHOPAEDIC TRIAL IMPLANTS) TYPE OF REQUEST CODE SUPPORT INFO RATIONALE EXTENDED RATIONALE INSERT Z12139007 - ORTHOPAEDIC TRIAL IMPLANTS A review of the currently existing EMDN codes shows that none accurately reflect the characteristics and intended use of the device. This intended use applies to sterile trial, for which no existing code is appropriate. Using an existing but inaccurate code could lead to misclassification and confusion regarding the device’s actual function, clinical use, and regulatory requirements. Therefore, a new specific code is necessary to ensure clarity and consistency in classification. intended use: A surgical instrument, designed as a copy of a final prosthetic implant or component, used to determine the correct alignment, size, and fit of the final prosthesis. The inclusion of new levels is planned to include types of devices not present in the current version of the EMDN (refer to L0923 ORTHOPAEDICS SURGICAL MEASURERS, REUSABLE) The technical assessment determined that trial implants—being replicas used to verify dimensions and intraoperative positioning—can be appropriately classified under the existing code V060101 (ORTHOPAEDIC PROSTHESES TESTING DEVICES). The evaluation highlighted the need to update the terminology across the entire V06 section; it was therefore proposed to replace the term "SIMULATION DEVICES" with "TRIAL DEVICES" to make it easier for manufacturers to identify these products. [bookmark: _Toc403390898][bookmark: _Toc236388343]OUTCOME: PARTIALLY ACCEPTED · [bookmark: _Toc236388344]ID 1575 (INSERT L0929 - ORTHOPEDIC SURGERY AND TRAUMATOLOGICAL IMPACTORS, REUSABLE); ID 1578 (INSERT L0933- ORTHOPEDIC IMPLANT/INSTRUMENT ASSEMBLING DEVICE, REUSABLE); 1582 (INSERT Z12139008 - ORTHOPAEDIC SURGERY PINS) Rationale: Evidence from Medical Device Databases confirmed that manufacturers already predominantly classify impactors, assembling tools, and alignment pins under the existing code L091104. To prevent nomenclature fragmentation and the proliferation of redundant terminal codes, it was determined that expanding the scope of this existing level is preferable to creating new codes. Consequently, the term for level L091104 has been updated to "ORTHOPAEDIC SURGERY IMPLANT HOLDING, ASSEMBLY, INSERTION AND ALIGNMENT INSTRUMENTS, REUSABLE". This modification comprehensively covers the full surgical workflow of prosthetic management—from preparation to final alignment—ensuring taxonomic clarity and maintaining consistency with the harmonization logic applied to the Neurosurgery and Spinal Surgery section (L11). · [bookmark: _Toc236388345]ID 1576 (INSERT L0930- ORTHOPEDIC SURGERY HANDLES, REUSABLE) Rationale: The review highlighted that many surgical handles are technically and functionally inseparable from mandrels in modular instrument sets. The evidence confirmed the necessity for an updated level that accurately reflects the modular nature of these instruments. Instead of creating a new code, existing level L098001 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY MANDRELS, REUSABLE was revised to "ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY HANDLES AND MANDRELS, REUSABLE", extending its scope to explicitly include all manual reusable handles and prevent unnecessary fragmentation. · [bookmark: _Toc236388346]ID 1577 (INSERT L0932 - ORTHOPAEDIC BONE PREPARATION PROTECTOR, REUSABLE) Rationale: Database searches identified multiple registrations for soft tissue protection sleeves and plates within the L0999 subset. The evidence from EUDAMED and national databases confirmed the necessity for the insertion of a dedicated level. The new terminal code L0928 ORTHOPAEDIC SURGERY BONE AND SOFT TISSUE PROTECTORS, REUSABLE was created to consolidate these safety instruments into a single, searchable level. · [bookmark: _Toc236388347]ID 1580 (INSERT L091107- ORTHOPAEDIC PROSTHESES BENDER, REUSABLE) Rationale: Database research confirmed that "implant benders" were frequently registered in Category L0999, justifying a specific terminal level. The evidence confirmed the necessity for a dedicated level to cover the intraoperative process of prosthetic modification. The new code L091107 ORTHOPAEDIC SURGERY IMPLANT BENDING, SHAPING AND CUTTING INSTRUMENTS, REUSABLE was established to provide accurate classification for these high-usage tools. The proposed code was harmonized with similar updates in the Neurosurgery section (L11). · [bookmark: _Toc236388348]ID 1583 (INSERT L0935- ORTHOPAEDIC SURGERY PUNCHES, REUSABLE) Rationale: The evaluation identified a functional and mechanical affinity between bone punches and trephines. Database searches in medical device database identified a huge number of registrations for bone punches in 99 residual codes. Following the harmonization logic applied to other EMDN sections, it was determined that bone punches and trephines should be grouped together. Consequently, level L090902 was updated to "ORTHOPAEDIC SURGERY BONE PUNCHES AND TREPHINES, REUSABLE" instead of creating a new redundant code. · [bookmark: _Toc236388349]ID 1584 - ID 1586 (duplication) (INSERT L0936- ORTHOPAEDIC SURGERY AWLS, REUSABLE) Rationale: Database evidence confirmed that these devices are functionally distinct from manual perforators (found in L0927), as awls create channels through pressure or impaction rather than rotation and chip removal. The evidence confirmed the necessity for a dedicated level due to the functional distinction between awls and rotary perforators. The new terminal level L0929 ORTHOPAEDIC SURGERY BONE AWLS, REUSABLE was created to address this classification gap. ADDITIONAL PROPOSAL · The assessments conducted highlighted the need to correct the translation of the Italian term "BISTURI" in “CHISELS” for the levels L0904, L090402, L090404. · The evaluation of request 1585 (alongside request 1597) highlighted the need to update the terminology across the entire V06 section; it was therefore proposed to replace the term "SIMULATION DEVICES" with "TRIAL DEVICES" to make it easier for manufacturers to identify these products. PROPOSAL CODE LEVEL TERMINAL LEVEL (YES/NO) TERM DESCRIZIONE L09 2 NO [bookmark: _Hlk233896354]ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE  STRUMENTARIO PER CHIRURGIA ORTOPEDICA E TRAUMATOLOGICA, RIUTILIZZABILE L0901 3 YES ORTHOPAEDIC SURGERY SPOONS AND CURETTES, REUSABLE CUCCHIAI E CURETTE PER CHIRURGIA ORTOPEDICA, RIUTILIZZABILI L0902 3 YES ORTHOPAEDIC SURGERY LEVERS, REUSABLE LEVE PER CHIRURGIA ORTOPEDICA, RIUTILIZZABILI L0903 3 YES ORTHOPAEDIC SURGERY HAMMERS, REUSABLE MARTELLI PER CHIRURGIA ORTOPEDICA, RIUTILIZZABILI L0904 3 NO OSTEOTOMES AND SCALPELS CHISELS, REUSABLE OSTEOTOMI E SCALPELLI, RIUTILIZZABILI L090401 4 YES ORTHOPAEDIC SURGERY OSTEOTOMES, REUSABLE OSTEOTOMI PER CHIRURGIA ORTOPEDICA, RIUTILIZZABILI L090402 4 YES ORTHOPAEDIC SURGERY SCALPELS CHISELS, REUSABLE SCALPELLI PER CHIRURGIA ORTOPEDICA, RIUTILIZZABILI L090403 4 YES ORTHOPAEDIC SURGERY GOUGES, REUSABLE SGORBIE PER CHIRURGIA ORTOPEDICA, RIUTILIZZABILI L090404 4 YES OSTEOTOMES AND SCALPELS CHISELS BLADES, REUSABLE LAME PER OSTEOTOMI E SCALPELLI, RIUTILIZZABILI L0908 3 YES ORTHOPAEDIC AND TRAUMATOLOGICAL TRACTION INSTRUMENTS, REUSABLE STRUMENTARIO PER TRAZIONE ORTOPEDICA E TRAUMATOLOGICA, RIUTILIZZABILE L0909 3 NO ORTHOPAEDIC SURGERY CUTTING INSTRUMENTS, REUSABLE STRUMENTI DA TAGLIO PER CHIRURGIA ORTOPEDICA, RIUTILIZZABILI L090901 4 YES BONE CUTTERS, REUSABLE TRONCHESI PER OSSA, RIUTILIZZABILI L090902 4 YES ORTHOPAEDIC SURGERY BONE PUNCHES AND TREPHINES, REUSABLE PUNZONI OSSEI E TREFINE PER CHIRURGIA ORTOPEDICA, RIUTILIZZABILI L090903 4 YES ORTHOPAEDIC SURGERY SCALPELS AND KNIVES, REUSABLE BISTURI E COLTELLI PER CHIRURGIA ORTOPEDICA, RIUTILIZZABILI L090999 4 YES ORTHOPAEDIC SURGERY CUTTING INSTRUMENTS, REUSABLE - OTHER STRUMENTI DA TAGLIO PER CHIRURGIA ORTOPEDICA, RIUTILIZZABILI - ALTRI L0910 3 NO OSTEOSYNTHESIS INSTRUMENTS, REUSABLE STRUMENTARIO PER OSTEOSINTESI, RIUTILIZZABILE L091001 4 YES INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE STRUMENTI PER INSERIMENTO E ESTRAZIONE DI MATERIALI PER OSTEOSINTESI, RIUTILIZZABILI L091002 4 YES INSTRUMENTS FOR PROCESSING MATERIALS FOR OSTEOSYNTHESIS, REUSABLE STRUMENTI PER LAVORAZIONE DI MATERIALI PER OSTEOSINTESI, RIUTILIZZABILI L091099 4 YES OSTEOSYNTHESIS INSTRUMENTS, REUSABLE - OTHER STRUMENTARIO PER OSTEOSINTESI, RIUTILIZZABILE - ALTRO L0911 3 NO ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE STRUMENTARIO PER PROTESICA ORTOPEDICA, RIUTILIZZABILE L091101 4 YES ORTHOPAEDIC PROSTHESES AND TRAUMATOLOGICAL IMPLANTS EXTRACTORS, REUSABLE ESTRATTORI PER PROTESI ORTOPEDICHE E IMPIANTI TRAUMATOLOGICI, RIUTILIZZABILI L091102 4 YES ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE ALESATORI E FRESE PER PROTESI ORTOPEDICHE, RIUTILIZZABILI L091103 4 YES ORTHOPAEDIC PROSTHESES FORCEPS, REUSABLE PINZE PER PROTESI ORTOPEDICHE, RIUTILIZZABILI L091104 4 YES ORTHOPAEDIC PROSTHESES POSITIONERS SURGERY IMPLANT HOLDING, ASSEMBLY, INSERTION AND ALIGNMENT INSTRUMENTS, REUSABLE POSIZIONATORI PER PROTESI ORTOPEDICHE STRUMENTARIO PER LA PRESA, L'ASSEMBLAGGIO, L'INSERIMENTO E L'ALLINEAMENTO DI IMPIANTI IN CHIRURGIA ORTOPEDICA, RIUTILIZZABILE L091105 4 YES CEMENTATION INSTRUMENTS, REUSABLE STRUMENTARIO PER CEMENTAZIONE, RIUTILIZZABILE L091106 4 YES INSTRUMENTS FOR THE PREPARATION OF TISSUE IMPLANTS IN ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY, REUSABLE STRUMENTARIO PER PREPARAZIONE DI IMPIANTI TESSUTALI IN CHIRURGIA ORTOPEDICA E TRAUMATOLOGICA, RIUTILIZZABILE L091107 4 YES [bookmark: _Hlk234395331]ORTHOPAEDIC SURGERY IMPLANT BENDING, SHAPING AND CUTTING INSTRUMENTS, REUSABLE STRUMENTARIO PER LA PIEGATURA, MODELLAZIONE E IL TAGLIO DI IMPIANTI IN CHIRURGIA ORTOPEDICA, RIUTILIZZABILE L091199 4 YES ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER STRUMENTARIO PER PROTESICA ORTOPEDICA, RIUTILIZZABILE - ALTRO L0912 3 NO ORTHOPAEDIC RASPS AND FILES, REUSABLE RASPE E LIME ORTOPEDICHE, RIUTILIZZABILI L091201 4 YES ORTHOPAEDIC SURGERY RASPS, REUSABLE RASPE PER CHIRURGIA ORTOPEDICA, RIUTILIZZABILI L091202 4 YES ORTHOPAEDIC SURGERY FILES, REUSABLE LIME PER CHIRURGIA ORTOPEDICA, RIUTILIZZABILI L0913 3 NO ORTHOPAEDIC SURGERY FORCEPS, REUSABLE PINZE PER CHIRURGIA ORTOPEDICA, RIUTILIZZABILI L091301 4 YES BONE GRASPS, REUSABLE PINZE DA PRESA PER OSSO, RIUTILIZZABILI L091302 4 YES BONE RONGEURS, REUSABLE PINZE OSSIVORE, RIUTILIZZABILI L091303 4 YES BONE REDUCTION FORCEPS, REUSABLE PINZE DA RIDUZIONE OSSEA, RIUTILIZZABILI L091304 4 YES SEQUESTRIAL PLIERS, REUSABLE PINZE PER SEQUESTRI, RIUTILIZZABILI L091305 4 YES FORCEPS FOR TENDONS AND LIGAMENTS, REUSABLE PINZE PER TENDINI E LEGAMENTI, RIUTILIZZABILI L091306 4 YES CARTILAGE FORCEPS, REUSABLE PINZE PER CARTILAGINE, RIUTILIZZABILI L091307 4 YES ORTHOPAEDIC SURGERY RONGEURS, REUSABLE RONGEURS PER CHIRURGIA ORTOPEDICA, RIUTILIZZABILI L091399 4 YES ORTHOPAEDIC SURGERY FORCEPS, REUSABLE - OTHER PINZE PER CHIRURGIA ORTOPEDICA, RIUTILIZZABILI - ALTRE L0914 3 YES SCOLLAPERIOSTIUM AND PERIOSTEOTOMES, REUSABLE SCOLLAPERIOSTIO E PERIOSTOTOMI, RIUTILIZZABILI L0915 3 YES SPREADERS AND RETRACTORS FOR ORTHOPAEDIC SURGERY, REUSABLE DIVARICATORI E RETRATTORI PER CHIRURGIA ORTOPEDICA, RIUTILIZZABILI L0916 3 YES ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLE FRESE E PUNTE PER CHIRURGIA ORTOPEDICA, RIUTILIZZABILI L0917 3 YES ORTHOPAEDIC SPATULAS, REUSABLE SPATOLE ORTOPEDICHE, RIUTILIZZABILI L0918 3 YES ORTHOPAEDIC TUNNELISERS, REUSABLE TUNNELLIZZATORI ORTOPEDICI, RIUTILIZZABILI L0919 3 YES ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENT KITS, REUSABLE KIT DI STRUMENTARIO PER CHIRURGIA ORTOPEDICA E TRAUMATOLOGICA, RIUTILIZZABILE L0920 3 YES ORTHOPAEDIC SURGERY DISTRACTORS, REUSABLE DISTRATTORI PER CHIRURGIA ORTOPEDICA, RIUTILIZZABILI L0921 3 YES NON-IMPLANTABLE ORTHOPAEDIC DEVICES EXTRACTORS, REUSABLE ESTRATTORI PER DISPOSITIVI ORTOPEDICI NON IMPIANTABILI, RIUTILIZZABILI L0922 3 YES ORTHOPAEDIC SURGERY GUIDES, REUSABLE GUIDE PER CHIRURGIA ORTOPEDICA, RIUTILIZZABILI L0923 3 YES ORTHOPAEDICS SURGICAL MEASURERS, REUSABLE MISURATORI CHIRURGICI PER ORTOPEDIA, RIUTILIZZABILI L0924 3 YES TENOTOMES, REUSABLE TENOTOMI RIUTILIZZABILI L0925 3 YES ORTHOPAEDIC SURGERY DILATORS, REUSABLE DILATATORI PER CHIRURGIA ORTOPEDICA, RIUTILIZZABILI L0926 3 YES ORTHOPAEDIC SURGERY DISSECTORS, REUSABLE DISSETTORI PER CHIRURGIA ORTOPEDICA RIUTILIZZABILI L0927 3 YES ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE PERFORATORI MANUALI PER CHIRURGIA ORTOPEDICA, RIUTILIZZABILI L0928 3 YES ORTHOPAEDIC SURGERY BONE AND SOFT TISSUE PROTECTORS, REUSABLE STRUMENTARIO DI PROTEZIONE PER OSSA E TESSUTI PER CHIRURGIA ORTOPEDICA, RIUTILIZZABILE L0929 3 YES ORTHOPAEDIC SURGERY BONE AWLS, REUSABLE LESINE PER CHIRURGIA ORTOPEDICA, RIUTILIZZABILI L0980 3 NO ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - ACCESSORIES STRUMENTARIO PER CHIRURGIA ORTOPEDICA E TRAUMATOLOGICA, RIUTILIZZABILE - ACCESSORI [bookmark: _Hlk234335119]L098001 4 YES ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY HANDLES AND MANDRELS, REUSABLE MANICI E MANDRINI PER CHIRURGIA ORTOPEDICA E TRAUMATOLOGICA, RIUTILIZZABILI L098002 4 YES ORTHOPAEDIC INSTRUMENTS KEYS, REUSABLE CHIAVI PER STRUMENTARIO ORTOPEDICO, RIUTILIZZABILI L098003 4 YES ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY TAPS, REUSABLE MASCHIATORI PER CHIRURGIA ORTOPEDICA E TRAUMATOLOGICA, RIUTILIZZABILI L098099 4 YES ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER ACCESSORIES STRUMENTARIO PER CHIRURGIA ORTOPEDICA E TRAUMATOLOGICA, RIUTILIZZABILE - ACCESSORI ALTRI L0999 3 YES ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER STRUMENTARIO PER CHIRURGIA ORTOPEDICA E TRAUMATOLOGICA, RIUTILIZZABILE - ALTRO … … … V 1 NO VARIOUS MEDICAL DEVICES DISPOSITIVI VARI … … … V06 2 NO CLINICAL PROCEDURE SIMULATION TRIAL DEVICES DISPOSITIVI PER SIMULAZIONE DI PROCEDURE CLINICHE V0601 3 NO ORTHOPAEDIC AND TRAUMATOLOGY PROCEDURES SIMULATION TRIAL DEVICES DISPOSITIVI PER SIMULAZIONE DI PROCEDURE ORTOPEDICHE E TRAUMATOLOGICHE V060101 4 NO ORTHOPAEDIC PROSTHESES SIMULATION TRIAL DEVICES DISPOSITIVI DI PROVA PER PROTESI ORTOPEDICHE V06010101 5 YES HIP PROSTHESES SIMULATION TRIAL DEVICES DISPOSITIVI DI PROVA PER PROTESI D'ANCA V06010102 5 YES KNEE PROSTHESES SIMULATION TRIAL DEVICES DISPOSITIVI DI PROVA PER PROTESI DI GINOCCHIO V06010103 5 YES SHOULDER PROSTHESES SIMULATION TRIAL DEVICES DISPOSITIVI DI PROVA PER PROTESI DI SPALLA V06010199 5 YES ORTHOPAEDIC PROSTHESES SIMULATION TRIAL DEVICES - OTHER DISPOSITIVI DI PROVA PER PROTESI ORTOPEDICHE - ALTRI V060102 4 YES SPINAL SURGERY SIMULATION TRIAL DEVICES DISPOSITIVI DI PROVA PER CHIRURGIA SPINALE V0602 3 YES VASCULAR PROCEDURES SIMULATION TRIAL DEVICES DISPOSITIVI PER SIMULAZIONE DI PROCEDURE VASCOLARI V0603 3 YES DENTAL PROCEDURES SIMULATION TRIAL DEVICES DISPOSITIVI PER SIMULAZIONE DI PROCEDURE ODONTOIATRICHE V0604 3 YES GENERAL SURGICAL PROCEDURES SIMULATION TRIAL DEVICES DISPOSITIVI PER SIMULAZIONE DI PROCEDURE CHIRURGICHE GENERALI V0605 3 YES OPHTHALMOLOGICAL PROCEDURES SIMULATION TRIAL DEVICES DISPOSITIVI PER SIMULAZIONE DI PROCEDURE OFTALMOLOGICHE V0606 3 YES BREAST SURGERY SIMULATION TRIAL DEVICES DISPOSITIVI DI PROVA PER CHIRURGIA MAMMARIA V0607 3 YES OSTEOSYNTHESIS IMPLANTS SIMULATION TRIAL DEVICES DISPOSITIVI DI PROVA PER IMPIANTI DI OSTEOSINTESI V0680 3 YES CLINICAL PROCEDURES SIMULATION TRIAL DEVICES - ACCESSORIES DISPOSITIVI PER SIMULAZIONE DI PROCEDURE CLINICHE - ACCESSORI V0699 3 YES CLINICAL PROCEDURE SIMULATION TRIAL DEVICES - OTHER DISPOSITIVI PER SIMULAZIONE DI PROCEDURE CLINICHE - ALTRI [bookmark: _Toc1282005153][bookmark: _Toc236388350]ID 1596; ID 1597; ID 1598; ID 1599; ID 1600, ID 1601; ID 1602; ID 1603; ID 1604; ID 1605, ID 1606 - SURGERY INSTRUMENTS, REUSABLE [bookmark: _Toc2121840687][bookmark: _Toc236388351]REQUESTS DETAILS ID EMDN \Category- EMDN Group EMDN Code or Reference Type of update Proposal (specify Code XXX – Term XXX) Supporting information [bookmark: _Hlk226026372]1596 L L03 INSERT L0319 - IMPLANT INSERTERS missing term 1597 V L03 INSERT L0320 - TRIAL IMPLANTS missing term 1598 L L03 INSERT L0321 - SURGICAL CHISELS missing term [bookmark: _Hlk233287451]1599 L L03 INSERT L0322 - SURGICAL RONGEURS term missing 1600 L L09 INSERT L0928 - MANUAL ORTHOPAEDIC BENDER, REUSABLE term missing 1601 L L03 INSERT L0323 - SURGICAL INSTRUMENT HANDLES missing term 1602 L L03 INSERT L0324 - SURGICAL HAND DRILLS missing term 1603 L L03 INSERT L0325 - SURGICAL ALIGNMENT TOOL missing term 1604 L L03 INSERT L0325 - SURGICAL IMPLANT TEMPLATE, REUSABLE missing term 1605 L L03 INSERT L0326 - BONE AWL, REUSABLE missing term 1606 L L09 INSERT L090904 - ORTHOPAEDIC IMPLANTABLE-DEVICE CUTTER missing term Additional Information received attached or sent upon request · IFU [bookmark: _Toc366034162][bookmark: _Toc236388352]DESCRIPTION OF DEVICES The devices analysed are specialized manual instruments required for various stages of spinal implantation procedures: · Implant Inserters and Alignment Tools (ID 1596, 1603): Reusable stainless steel manual instruments designed to support, guide, position, and align spinal implants such as ALIF, PLIF, and TLIF interbody fusion cages, cervical plates, or vertebral body replacements. These may feature internal rods to securely lock the implant during placement or specialized components like fixation pins intended for temporary plate stabilization prior to screw fixation. · Trial Implants (ID 1597): Reusable manual surgical aids manufactured from mechanically resistant stainless steel. They mirror the footprint and geometry of definitive implants (cages, plates, or vertebral body replacements) to intraoperatively determine the most suitable size, height, and angulation for each patient · Surgical Chisels (ID 1598): Hand-held sharp-tipped instruments with ergonomic handles used to accurately shape bone structures, remove fragments, or prepare vertebral endplate surfaces for implant insertion. · Surgical Rongeurs (ID 1599): Curved manual instruments with sharp, scoop-shaped jaws designed to cut through and remove tissue from the intervertebral disc and tough fibrocartilaginous material during site preparation. · Implant Benders and Cutters (ID 1600, 1606): Heavy-duty manual tools for intraoperative implant contouring. Benders (for rods, connectors, and plates) utilize ergonomic polymer handles (PPSU or PEEK) to provide controlled shaping of titanium or steel components. Rod Cutters use high mechanical leverage to shear spinal rods (up to 5.5mm diameter) to the exact length required by the patient’s anatomy. · Instrument Handles (ID 1601): Reusable driving attachments for modular tools such as taps and screwdrivers, constructed from stainless steel and biocompatible polymers. These include standard AO handles, torque-limited drivers, and ratcheting versions. · Manual Drill Bits (ID 1602): Reusable bone-cutting bits (e.g., Drill HB) with specialized cutting tips and coupling geometry for manual handles, designed to create precise holes in hard bone structures like cervical vertebrae. · Implant Templates (ID 1604): Flexible stainless steel manual templates used intraoperatively to verify the correct length and curvature needed for a final spinal rod before selection. · Bone Awls (ID 1605): Pointed instruments with sharp tips and ergonomic handles designed to determine precise pedicle entry points and open initial pedicle channels for safe screw insertion. [bookmark: _Toc654850365][bookmark: _Toc236388353]OUTCOME The analysis evaluates a series of requests (IDs 1596–1606) for new EMDN codes for reusable manual surgical instruments. Although initially proposed for General Surgery (L03) or Orthopaedic (L09) sections, the technical documentation identifies them as specific to spinal surgery. Therefore, the analysis was conducted to update Section L11. [bookmark: _Toc575826489][bookmark: _Toc236388354]OUTCOME: NOT ACCEPTED · [bookmark: _Toc236388355]ID 1597 ( INSERT L0320 - TRIAL IMPLANTS) Rationale: These manual instruments are used intraoperatively to mirror the geometry of permanent implants for sizing and positioning verification. They can be appropriately associated with the existing level V060102 SPINAL SURGERY TESTING DEVICES. Another proposal suggests using the term “V060102” with terminology that is more in line with that used by manufacturers. TYPE OF REQUEST CODE SUPPORT INFO RATIONALE EXTENDED RATIONALE INSERT L0320 - TRIAL IMPLANTS missing term The inclusion of new levels is planned to include types of devices not present in the current version of the EMDN (refer to V060102 SPINAL SURGERY TESTING TRIAL DEVICES) These manual instruments are used intraoperatively to mirror the geometry of permanent implants for sizing and positioning verification. They can be appropriately associated with the existing level V060102 SPINAL SURGERY TESTING DEVICES. Another proposal suggests using the term “V060102” with terminology that is more in line with that used by manufacturers (V060102 SPINAL SURGERY TESTING TRIAL DEVICES). · [bookmark: _Toc236388356]ID 1604 (INSERT L0325 - SURGICAL IMPLANT TEMPLATE, REUSABLE) Rationale: These templates are used to determine correct rod length and curvature. They are appropriately associated with the existing level V030204 IMPLANT MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES. TYPE OF REQUEST CODE SUPPORT INFO RATIONALE EXTENDED RATIONALE INSERT L0325 - SURGICAL IMPLANT TEMPLATE, REUSABLE missing term The inclusion of new levels is planned to include types of devices not present in the current version of the EMDN (refer to V030204 IMPLANT MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES) These templates are used to determine correct rod length and curvature. They are appropriately associated with the existing level V030204 IMPLANT MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES. [bookmark: _Toc675288420][bookmark: _Toc236388357]OUTCOME: PARTIALLY ACCEPTED · [bookmark: _Toc236388358]ID 1596 (INSERT L0319 - IMPLANT INSERTERS) Creation of new code: L1114. English Term: SPINAL IMPLANT HOLDING, ASSEMBLY, INSERTION AND ALIGNMENT INSTRUMENTS, REUSABLE. Rationale: Analysis of the L11*99 category identified numerous records for implant holders and positioning devices currently lacking a specific terminal level. To ensure taxonomic clarity, a comprehensive category was created to include all functional stages of implant management: holding, assembly, insertion, and alignment. The term has been harmonized the update proposal for L09 section specifically with L091104 term. · [bookmark: _Toc236388359]ID 1598 (INSERT L0321 - SURGICAL CHISELS) Creation of new code L1115. English Term: NEUROSURGERY BONE CHISELS AND OSTEOTOMES, REUSABLE. Rationale: This proposal was harmonized with existing levels in L0904, L1406, and L1501, which logically group chisels and osteotomes together under a single code to avoid excessive nomenclature fragmentation. Having verified the availability of osteotomes specifically designed for neurosurgery, the creation of a category that includes both types of devices is proposed. · [bookmark: _Toc236388360]ID 1599 (INSERT L0322 - SURGICAL RONGEURS) Update existing levels L1106 and L110604. English Terms: · L1106: NEUROSURGERY FORCEPS AND RONGEURS, REUSABLE. · L110604: NEUROSURGERY BONE AND TISSUE RESECTION RONGEURS, REUSABLE. Rationale: Eudamed analysis revealed over 200 UDI-DIs for bone rongeurs improperly registered in generic categories. The term update clarifies that these levels include instruments with cutting jaws for the controlled resection of both bone and tissue (such as Kerrison or pituitary rongeurs), rather than just soft tissue forceps. · [bookmark: _Toc236388361]ID 1600 ( INSERT L0928 - MANUAL ORTHOPAEDIC BENDERS, REUSABLE) Creation of new code L1116. English Term: SPINAL IMPLANT BENDING, SHAPING AND CUTTING INSTRUMENTS, REUSABLE. Rationale: Requests for plate/rod benders (ID 1600) and rod cutters (ID 1606) were merged into a single functional level. This reflects the surgical workflow where implants are contoured and cut to fit the patient's specific anatomy during the same procedural phase. The reference "SPINAL" was added for consistency with the spinal fixation focus. · [bookmark: _Toc236388362]ID 1601 (INSERT L0323 - SURGICAL INSTRUMENT HANDLES) Creation of new code L1117. English Term: NEUROSURGERY HANDLES AND MANDRELS, REUSABLE. Rationale: Following the harmonization strategy used for the update proposal for L09 section, specifically with L098001 level, handles and mandrels were grouped into a single level to minimize redundant terminal codes for modular instrument attachments. · [bookmark: _Toc236388363]ID 1602 (INSERT L0324 - SURGICAL HAND DRILLS) Creation of new code L1119. English term: NEUROSURGERY MANUAL DRILLS, REUSABLE rationale: the reference device provided by the user was identified as a drill bit, for which a specific classification already exists under level L1104 bits for neurosurgery drills, reusable. however, because the technical analysis and database research highlighted the existence of the complete manual drill, the insertion of a dedicated level, L1119 neurosurgery manual drills, reusable, was still included in the final proposal to address this nomenclature gap. · [bookmark: _Toc236388364]ID 1603 (INSERT L0325 - SURGICAL ALIGNMENT TOOL) Creation of new code L1114. English Term: SPINAL IMPLANT HOLDING, ASSEMBLY, INSERTION AND ALIGNMENT INSTRUMENTS, REUSABLE. Rationale: Analysis of the L11*99 category identified numerous records for implant holders and positioning devices currently lacking a specific terminal level. To ensure taxonomic clarity, a comprehensive category was created to include all functional stages of implant management: holding, assembly, insertion, and alignment. The term has been harmonized the update proposal for L09 section specifically with L091104 term. · [bookmark: _Toc236388365]ID 1605 (INSERT L0326 - BONE AWL, REUSABLE) Creation of new code L1118. English Term: NEUROSURGERY BONE AWLS, REUSABLE. Rationale: These awls are specialized for determining pedicle entry points and opening initial pedicle channels, making them functionally distinct from general-purpose bone awls. · [bookmark: _Toc236388366]ID 1606 (INSERT L090904 - ORTHOPAEDIC IMPLANTABLE-DEVICE CUTTER) Creation of new code L1116. English Term: SPINAL IMPLANT BENDING, SHAPING AND CUTTING INSTRUMENTS, REUSABLE. Rationale: Requests for plate/rod benders (ID 1600) and rod cutters (ID 1606) were merged into a single functional level. This reflects the surgical workflow where implants are contoured and cut to fit the patient's specific anatomy during the same procedural phase. The reference "SPINAL" was added for consistency with the spinal fixation focus. [bookmark: _Toc236388367]PROPOSAL (ID 1596 – 1598 – 1599 – 1600 – 1601 – 1602 – 1603 – 1605 – 1606) CODE LEVEL TERMINAL LEVEL (YES/NO) TERM DESCRIZIONE L11 2 NO NEUROSURGERY AND SPINAL SURGERY INSTRUMENTS, REUSABLE STRUMENTARIO PER NEUROCHIRURGIA E CHIRURGIA SPINALE, RIUTILIZZABILE L1102 3 YES NEUROSURGERY SPATULAS AND DISSECTORS, REUSABLE SPATOLE E DISSETTORI PER NEUROCHIRURGIA, RIUTILIZZABILI L1103 3 YES CERVICAL TRACTION BRACKETS, REUSABLE STAFFE DI TRAZIONE CERVICALE, RIUTILIZZABILI L1104 3 YES BITS FOR NEUROSURGERY DRILLS, REUSABLE PUNTE PER TRAPANI PER NEUROCHIRURGIA, RIUTILIZZABILI L1105 3 NO NEUROSURGERY SPREADERS AND RETRACTORS, REUSABLE DIVARICATORI E RETRATTORI PER NEUROCHIRURGIA, RIUTILIZZABILI L110501 4 NO VERTEBRAL SURGERY SPREADERS AND RETRACTORS, REUSABLE DIVARICATORI E RETRATTORI PER CHIRURGIA VERTEBRALE, RIUTILIZZABILI L11050101 5 YES LAMINECTOMY SPREADERS AND RETRACTORS, REUSABLE DIVARICATORI E RETRATTORI PER LAMINECTOMIA, RIUTILIZZABILI L11050199 5 YES VERTEBRAL SURGERY SPREADERS AND RETRACTORS, REUSABLE - OTHER DIVARICATORI E RETRATTORI PER CHIRURGIA VERTEBRALE, RIUTILIZZABILI - ALTRI L110502 4 YES NERVES AND VESSELS HOOK RETRACTORS, REUSABLE UNCINI DIVARICATORI PER NERVI E VASI, RIUTILIZZABILI L110503 4 NO CRANIAL SURGERY SPREADERS AND RETRACTORS, REUSABLE DIVARICATORI E RETRATTORI PER CHIRURGIA CRANICA, RIUTILIZZABILI L11050301 5 YES CEREBRAL SPREADERS AND RETRACTORS, REUSABLE DIVARICATORI E RETRATTORI CEREBRALI, RIUTILIZZABILI L11050399 5 YES CRANIAL SURGERY SPREADERS AND RETRACTORS, REUSABLE - OTHER DIVARICATORI E RETRATTORI PER CHIRURGIA CRANICA, RIUTILIZZABILI - ALTRI L110599 4 YES NEUROSURGERY SPREADERS AND RETRACTORS, REUSABLE - OTHER DIVARICATORI E RETRATTORI PER NEUROCHIRURGIA RIUTILIZZABILI - ALTRI L1106 3 NO NEUROSURGERY FORCEPS AND RONGEURS, REUSABLE PINZE E PINZE OSSIVORE (RONGEURS) PER NEUROCHIRURGIA, RIUTILIZZABILI L110601 4 YES DISC HERNIA FORCEPS, REUSABLE PINZE PER ERNIA DISCALE, RIUTILIZZABILI L110602 4 YES NEUROSURGERY GRIPPERS, REUSABLE PINZE DA PRESA PER NEUROCHIRURGIA, RIUTILIZZABILI L110603 4 NO CRANIAL CLIPS, REUSABLE CLIPS CRANICHE, RIUTILIZZABILI L11060301 5 YES SCALP CLIPS, REUSABLE CLIPS PER CUOIO CAPELLUTO, RIUTILIZZABILI L11060399 5 YES CRANIAL CLIPS, REUSABLE - OTHER CLIPS CRANICHE, RIUTILIZZABILI - ALTRE L110604 4 YES NEUROSURGERY BONE AND TISSUE RESECTION RONGEURS, REUSABLE PINZE OSSIVORE (RONGEURS) E PER RESEZIONE DEI TESSUTI PER NEUROCHIRURGIA, RIUTILIZZABILI L110699 4 YES NEUROSURGERY FORCEPS, REUSABLE - OTHER PINZE PER NEUROCHIRURGIA, RIUTILIZZABILI - ALTRE L1107 3 NO NEUROSURGERY SCALPELS AND KNIVES, REUSABLE BISTURI E COLTELLI PER NEUROCHIRURGIA, RIUTILIZZABILI L110701 4 NO CEREBRAL AND MENINGEAL SURGERY SCALPELS AND KNIVES, REUSABLE BISTURI E COLTELLI PER CHIRURGIA CEREBRALE E MENINGEA, RIUTILIZZABILI L11070101 5 YES LEUCOTOMES, REUSABLE LEUCOTOMI, RIUTILIZZABILI L11070199 5 YES CEREBRAL AND MENINGEAL SURGERY SCALPELS AND KNIVES, REUSABLE - OTHER BISTURI E COLTELLI PER CHIRURGIA CEREBRALE E MENINGEA, RIUTILIZZABILI - ALTRI L110702 4 YES CRANIAL TREPHINES, REUSABLE TREFINE CRANICHE, RIUTILIZZABILI L110799 4 YES NEUROSURGERY SCALPELS AND KNIVES, REUSABLE - OTHER BISTURI E COLTELLI PER NEUROCHIRURGIA, RIUTILIZZABILI - ALTRI L1108 3 YES NEUROSURGERY LEVERS, REUSABLE LEVE PER NEUROCHIRURGIA, RIUTILIZZABILI L1109 3 YES NEUROSURGERY AND SPINAL SURGERY INSTRUMENT KITS, REUSABLE KIT DI STRUMENTARIO PER NEUROCHIRURGIA E CHIRURGIA SPINALE, RIUTILIZZABILE L1110 3 YES NEUROSURGERY OBTURATORS, REUSABLE OTTURATORI PER NEUROCHIRURGIA, RIUTILIZZABILI L1111 3 YES NEUROSURGERY MANIPULATORS, REUSABLE MANIPOLATORI PER NEUROCHIRURGIA, RIUTILIZZABILI L1112 3 YES NEUROSURGERY SUCTION CANNULAS, REUSABLE CANNULE DI ASPIRAZIONE PER NEUROCHIRURGIA, RIUTILIZZABILI L1113 3 YES NEUROSURGERY BURS AND TIPS, REUSABLE FRESE E PUNTE PER NEUROCHIRURGIA, RIUTILIZZABILI L1114 3 YES SPINAL IMPLANT HOLDING, ASSEMBLY, INSERTION AND ALIGNMENT INSTRUMENTS, REUSABLE STRUMENTARIO PER LA PRESA, L'ASSEMBLAGGIO, L'INSERIMENTO E L'ALLINEAMENTO DI IMPIANTI SPINALI, RIUTILIZZABILE L1115 3 YES NEUROSURGERY BONE CHISELS AND OSTEOTOMES, REUSABLE SCALPELLI OSSEI E OSTEOTOMI PER NEUROCHIRURGIA, RIUTILIZZABILI L1116 3 YES SPINAL IMPLANT BENDING, SHAPING AND CUTTING INSTRUMENTS, REUSABLE STRUMENTARIO PER LA PIEGATURA, MODELLAZIONE E IL TAGLIO DI IMPIANTI SPINALI, RIUTILIZZABILE L1117 3 YES NEUROSURGERY HANDLES AND MANDRELS, REUSABLE MANICI E MANDRINI PER STRUMENTARIO MANUALE PER NEUROCHIRURGIA, RIUTILIZZABILE L1118 3 YES NEUROSURGERY BONE AWLS, REUSABLE LESINE PER NEUROCHIRURGIA, RIUTILIZZABILI L1119 3 YES NEUROSURGERY MANUAL DRILLS, REUSABLE TRAPANI MANUALI PER NEUROCHIRURGIA, RIUTILIZZABILI L1199 3 YES NEUROSURGERY INSTRUMENTS, REUSABLE - OTHER STRUMENTARIO PER NEUROCHIRURGIA, RIUTILIZZABILE - ALTRO [bookmark: _Toc1493208858][bookmark: _Toc236388368]ID 62_2026, ID 63_2026, ID 64_2026, ID 65_2026, ID 66_2026, ID 67_2026 – ROBOTIC SURGERY STAPLERS [bookmark: _Toc52486409][bookmark: _Toc236388369]REQUESTS DETAILS ID EMDN \Category- EMDN Code or Reference Type of update Proposal (specify Code XXX – Term XXX) Supporting information 62_2026 H H020301 NEW H020301040103 ROBOTIC SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR VIDEOSURGERY, SINGLE-USE Intended use: The devices are intended for transection and resection of tissue. IFU not available yet. 63_2026 H H020301 NEW H020301040203 ROBOTIC SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITHOUT BLADE FOR VIDEOSURGERY, SINGLE-USE Intended use: The devices are intended for transection and resection of tissue. IFU not available yet. 64_2026 H H020301 NEW H020301050203 ROBOTIC SINGLE PATIENT ARTICULATED LINEAR STAPLERS WITHOUT BLADE FOR VIDEO SURGERY Intended use: The devices are intended for transection and resection of tissue. IFU not available yet. 65_2026 H H020301 NEW H020301050103 ROBOTIC SINGLE PATIENT ARTICULATED LINEAR STAPLERS WITH BLADE FOR VIDEO SURGERY Intended use: The devices are intended for transection and resection of tissue. IFU not available yet. 66_2026 H H020302 NEW H0203020102 ROBOTIC SINGLE-USE CURVED CIRCULAR STAPLERS FOR VIDEOSURGERY Intended use: The devices are intended for creation of anastomoses. IFU not available yet. 67_2026 H H020302 NEW H0203020103 ROBOTIC SINGLE-USE CIRCULAR STAPLERS FOR VIDEOSURGERY Intended use: The devices are intended for creation of anastomoses. IFU not available yet. Additional Information received attached or sent upon request · None [bookmark: _Toc1779087849][bookmark: _Toc236388370]DESCRIPTION OF DEVICE The devices are robotic surgery staplers, which are electrically-powered surgical instruments designed to be used in conjunction with a robotic surgical system during endoscopic procedures. These devices consist of a long shaft with a distal stapling mechanism featuring an intrinsic "wristed" joint, allowing for full articulation, 360-degree rotation, and an extended range of motion (up, down, left, and right) to precisely position the jaws on the target tissue. The range includes several specialized configurations: · Linear Staplers (ID 62-65): Intended for the mechanical transection and resection of tissue, applying rows of staples while simultaneously cutting with an integrated blade (or without a blade in specific models). These are available in straight or articulated versions with standard or curved tips. · Circular Staplers (ID 66-67): Intended for the creation of surgical anastomoses, available with straight or curved head. Robotic staplers possess unique technological characteristics—specifically their motor-powered firing and high-degree "wristed" articulation—that distinguish them from conventional endoscopic stapling devices. [bookmark: _Toc1264137545][bookmark: _Toc236388371]OUTCOME PARTIALLY ACCEPTED Rationale: The evidence from the technical and market analysis confirmed the necessity for the insertion of a dedicated level for robotic surgery staplers. This was implemented through two progressive proposals to ensure both structural stability and market accuracy. After an evaluation of the robotic stapler market terminology, an update of H02030106 term from LINEAR STAPLER CARTRIDGES FOR VIDEOSURGERY to LINEAR STAPLER RELOADS FOR VIDEOSURGERY is include in both the proposals. PROPOSAL 1 The creation of a dedicated Level 4 code, H020304 - ROBOTIC SURGERY STAPLERS, was motivated by the need to establish a specific class for devices with distinct mechanical properties. This avoids misclassifying them within the existing EMDN structure—which was developed for technologically different devices—and provides a flexible framework capable of adapting to future market developments. CODE LEVEL TERMINAL LEVEL (YES/NO) TERM DESCRIZIONE H0203 3 NO STAPLERS FOR VIDEOSURGERY SUTURATRICI PER VIDEOCHIRURGIA H020301 4 NO LINEAR STAPLERS FOR VIDEOSURGERY SUTURATRICI LINEARI PER VIDEOCHIRURGIA H02030104 5 NO SINGLE PATIENT STRAIGHT LINEAR STAPLERS FOR VIDEOSURGERY SUTURATRICI LINEARI RETTE MONOPAZIENTE PER VIDEOCHIRURGIA H0203010401 6 NO SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR VIDEOSURGERY SUTURATRICI LINEARI RETTE MONOPAZIENTE CON LAMA PER VIDEOCHIRURGIA H020301040101 7 YES SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR THORACOSCOPY SUTURATRICI LINEARI RETTE MONOPAZIENTE CON LAMA PER TORACOSCOPIA H020301040102 7 YES SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR LAPAROSCOPY SUTURATRICI LINEARI RETTE MONOPAZIENTE CON LAMA PER LAPAROSCOPIA H020301040199 7 YES SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR VIDEOSURGERY - OTHER SUTURATRICI LINEARI RETTE MONOPAZIENTE CON LAMA PER VIDEOCHIRURGIA - ALTRE H0203010402 6 NO SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITHOUT BLADE FOR VIDEOSURGERY SUTURATRICI LINEARI RETTE MONOPAZIENTE SENZA LAMA PER VIDEOCHIRURGIA H020301040201 7 YES SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITHOUT BLADE FOR THORACOSCOPY SUTURATRICI LINEARI RETTE MONOPAZIENTE SENZA LAMA PER TORACOSCOPIA H020301040202 7 YES SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITHOUT BLADE FOR LAPAROSCOPY SUTURATRICI LINEARI RETTE MONOPAZIENTE SENZA LAMA PER LAPAROSCOPIA H020301040299 7 YES SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITHOUT BLADE FOR VIDEOSURGERY – OTHER SUTURATRICI LINEARI RETTE MONOPAZIENTE SENZA LAMA PER VIDEOCHIRURGIA - ALTRE H0203010499 6 YES SINGLE PATIENT STRAIGHT LINEAR STAPLERS FOR VIDEOSURGERY – OTHER SUTURATRICI LINEARI RETTE MONOPAZIENTE PER VIDEOCHIRURGIA - ALTRE H02030105 5 NO SINGLE PATIENT ARTICULATED LINEAR STAPLERS FOR VIDEO SURGERY SUTURATRICI LINEARI ARTICOLATE MONOPAZIENTE PER VIDEOCHIRURGIA H0203010501 6 NO SINGLE PATIENT ARTICULATED LINEAR STAPLERS WITH BLADE FOR VIDEO SURGERY SUTURATRICI LINEARI ARTICOLATE MONOPAZIENTE CON LAMA PER VIDEOCHIRURGIA H020301050101 7 YES SINGLE PATIENT ARTICULATED LINEAR STAPLERS WITH BLADE FOR THORACOSCOPY SUTURATRICI LINEARI ARTICOLATE MONOPAZIENTE CON LAMA PER TORACOSCOPIA H020301050102 7 YES SINGLE PATIENT ARTICULATED LINEAR STAPLERS WITH BLADE FOR LAPAROSCOPY SUTURATRICI LINEARI ARTICOLATE MONOPAZIENTE CON LAMA PER LAPAROSCOPIA H020301050199 7 YES SINGLE PATIENT ARTICULATED LINEAR STAPLERS WITH BLADE FOR VIDEOSURGERY – OTHER SUTURATRICI LINEARI ARTICOLATE MONOPAZIENTE CON LAMA PER VIDEOCHIRURGIA - ALTRE H0203010502 6 NO SINGLE PATIENT ARTICULATED LINEAR STAPLERS WITHOUT BLADE FOR VIDEO SURGERY SUTURATRICI LINEARI ARTICOLATE MONOPAZIENTE SENZA LAMA PER VIDEOCHIRURGIA H020301050201 7 YES SINGLE PATIENT ARTICULATED LINEAR STAPLERS WITHOUT BLADE FOR THORACOSCOPY SUTURATRICI LINEARI ARTICOLATE MONOPAZIENTE SENZA LAMA PER TORACOSCOPIA H020301050202 7 YES SINGLE PATIENT ARTICULATED LINEAR STAPLERS WITHOUT BLADE FOR LAPAROSCOPY SUTURATRICI LINEARI ARTICOLATE MONOPAZIENTE SENZA LAMA PER LAPAROSCOPIA H020301050299 7 YES SINGLE PATIENT ARTICULATED LINEAR STAPLERS WITHOUT BLADE FOR VIDEOSURGERY – OTHER SUTURATRICI LINEARI ARTICOLATE MONOPAZIENTE SENZA LAMA PER VIDEOCHIRURGIA - ALTRE H02030106 5 YES LINEAR STAPLER CARTRIDGES RELOADS FOR VIDEOSURGERY CARICATORI RICARICHE PER SUTURATRICI LINEARI PER VIDEOCHIRURGIA H02030199 5 YES LINEAR STAPLERS FOR VIDEOSURGERY - OTHER SUTURATRICI LINEARI PER VIDEOCHIRURGIA - ALTRE H020302 4 NO CIRCULAR STAPLERS FOR VIDEOSURGERY SUTURATRICI CIRCOLARI PER VIDEOCHIRURGIA H02030201 5 NO CURVED CIRCULAR STAPLERS FOR VIDEOSURGERY SUTURATRICI CIRCOLARI CURVE PER VIDEOCHIRURGIA H0203020101 6 YES SINGLE-USE CURVED CIRCULAR STAPLERS FOR VIDEOSURGERY SUTURATRICI CIRCOLARI CURVE MONOUSO PER VIDEOCHIRURGIA H0203020199 6 YES CIRCULAR STAPLERS FOR VIDEOSURGERY - OTHER SUTURATRICI CIRCOLARI CURVE PER VIDEOCHIRURGIA - ALTRE H02030299 5 YES CIRCULAR STAPLERS FOR VIDEOSURGERY – OTHER SUTURATRICI CIRCOLARI PER VIDEOCHIRURGIA - ALTRE H020303 4 YES CLIP APPLIERS APPLICATORI DI AGRAPHES H020304 4 YES ROBOTIC SURGERY STAPLERS SUTURATRICI PER CHIRURGIA ROBOTICA H020380 4 YES STAPLERS, VIDEOSURGERY - ACCESSORIES SUTURATRICI PER VIDEOCHIRURGIA - ACCESSORI H020399 4 YES STAPLERS, VIDEOSURGERY - OTHER SUTURATRICI PER VIDEOCHIRURGIA - ALTRE PROPOSAL 2 To ensure the nomenclature is consistent with the current market situation, a more granular structure was integrated, considering a classification distinguishing between standard tips, curved tips, and refills. The proposal specific sub-levels for linear staplers with standard tips (H02030401), curved tips (H02030402), and their respective reloads (H02030403). This detailed classification is justified by the fact that the available models differ primarily by head profile and cartridge type, and its implementation ensures that these high-risk instruments and their consumables are accurately identified and monitored separate from conventional surgical tools. CODE LEVEL TERMINAL LEVEL (YES/NO) TERM DESCRIZIONE H0203 3 NO STAPLERS FOR VIDEOSURGERY SUTURATRICI PER VIDEOCHIRURGIA H020301 4 NO LINEAR STAPLERS FOR VIDEOSURGERY SUTURATRICI LINEARI PER VIDEOCHIRURGIA H02030104 5 NO SINGLE PATIENT STRAIGHT LINEAR STAPLERS FOR VIDEOSURGERY SUTURATRICI LINEARI RETTE MONOPAZIENTE PER VIDEOCHIRURGIA H0203010401 6 NO SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR VIDEOSURGERY SUTURATRICI LINEARI RETTE MONOPAZIENTE CON LAMA PER VIDEOCHIRURGIA H020301040101 7 YES SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR THORACOSCOPY SUTURATRICI LINEARI RETTE MONOPAZIENTE CON LAMA PER TORACOSCOPIA H020301040102 7 YES SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR LAPAROSCOPY SUTURATRICI LINEARI RETTE MONOPAZIENTE CON LAMA PER LAPAROSCOPIA H020301040199 7 YES SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR VIDEOSURGERY - OTHER SUTURATRICI LINEARI RETTE MONOPAZIENTE CON LAMA PER VIDEOCHIRURGIA - ALTRE H0203010402 6 NO SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITHOUT BLADE FOR VIDEOSURGERY SUTURATRICI LINEARI RETTE MONOPAZIENTE SENZA LAMA PER VIDEOCHIRURGIA H020301040201 7 YES SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITHOUT BLADE FOR THORACOSCOPY SUTURATRICI LINEARI RETTE MONOPAZIENTE SENZA LAMA PER TORACOSCOPIA H020301040202 7 YES SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITHOUT BLADE FOR LAPAROSCOPY SUTURATRICI LINEARI RETTE MONOPAZIENTE SENZA LAMA PER LAPAROSCOPIA H020301040299 7 YES SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITHOUT BLADE FOR VIDEOSURGERY – OTHER SUTURATRICI LINEARI RETTE MONOPAZIENTE SENZA LAMA PER VIDEOCHIRURGIA - ALTRE H0203010499 6 YES SINGLE PATIENT STRAIGHT LINEAR STAPLERS FOR VIDEOSURGERY – OTHER SUTURATRICI LINEARI RETTE MONOPAZIENTE PER VIDEOCHIRURGIA - ALTRE H02030105 5 NO SINGLE PATIENT ARTICULATED LINEAR STAPLERS FOR VIDEO SURGERY SUTURATRICI LINEARI ARTICOLATE MONOPAZIENTE PER VIDEOCHIRURGIA H0203010501 6 NO SINGLE PATIENT ARTICULATED LINEAR STAPLERS WITH BLADE FOR VIDEO SURGERY SUTURATRICI LINEARI ARTICOLATE MONOPAZIENTE CON LAMA PER VIDEOCHIRURGIA H020301050101 7 YES SINGLE PATIENT ARTICULATED LINEAR STAPLERS WITH BLADE FOR THORACOSCOPY SUTURATRICI LINEARI ARTICOLATE MONOPAZIENTE CON LAMA PER TORACOSCOPIA H020301050102 7 YES SINGLE PATIENT ARTICULATED LINEAR STAPLERS WITH BLADE FOR LAPAROSCOPY SUTURATRICI LINEARI ARTICOLATE MONOPAZIENTE CON LAMA PER LAPAROSCOPIA H020301050199 7 YES SINGLE PATIENT ARTICULATED LINEAR STAPLERS WITH BLADE FOR VIDEOSURGERY – OTHER SUTURATRICI LINEARI ARTICOLATE MONOPAZIENTE CON LAMA PER VIDEOCHIRURGIA - ALTRE H0203010502 6 NO SINGLE PATIENT ARTICULATED LINEAR STAPLERS WITHOUT BLADE FOR VIDEO SURGERY SUTURATRICI LINEARI ARTICOLATE MONOPAZIENTE SENZA LAMA PER VIDEOCHIRURGIA H020301050201 7 YES SINGLE PATIENT ARTICULATED LINEAR STAPLERS WITHOUT BLADE FOR THORACOSCOPY SUTURATRICI LINEARI ARTICOLATE MONOPAZIENTE SENZA LAMA PER TORACOSCOPIA H020301050202 7 YES SINGLE PATIENT ARTICULATED LINEAR STAPLERS WITHOUT BLADE FOR LAPAROSCOPY SUTURATRICI LINEARI ARTICOLATE MONOPAZIENTE SENZA LAMA PER LAPAROSCOPIA H020301050299 7 YES SINGLE PATIENT ARTICULATED LINEAR STAPLERS WITHOUT BLADE FOR VIDEOSURGERY – OTHER SUTURATRICI LINEARI ARTICOLATE MONOPAZIENTE SENZA LAMA PER VIDEOCHIRURGIA - ALTRE H02030106 5 YES LINEAR STAPLER CARTRIDGES RELOADS FOR VIDEOSURGERY CARICATORI RICARICHE PER SUTURATRICI LINEARI PER VIDEOCHIRURGIA H02030199 5 YES LINEAR STAPLERS FOR VIDEOSURGERY - OTHER SUTURATRICI LINEARI PER VIDEOCHIRURGIA - ALTRE H020302 4 NO CIRCULAR STAPLERS FOR VIDEOSURGERY SUTURATRICI CIRCOLARI PER VIDEOCHIRURGIA H02030201 5 NO CURVED CIRCULAR STAPLERS FOR VIDEOSURGERY SUTURATRICI CIRCOLARI CURVE PER VIDEOCHIRURGIA H0203020101 6 YES SINGLE-USE CURVED CIRCULAR STAPLERS FOR VIDEOSURGERY SUTURATRICI CIRCOLARI CURVE MONOUSO PER VIDEOCHIRURGIA H0203020199 6 YES CIRCULAR STAPLERS FOR VIDEOSURGERY - OTHER SUTURATRICI CIRCOLARI CURVE PER VIDEOCHIRURGIA - ALTRE H02030299 5 YES CIRCULAR STAPLERS FOR VIDEOSURGERY – OTHER SUTURATRICI CIRCOLARI PER VIDEOCHIRURGIA - ALTRE H020303 4 YES CLIP APPLIERS APPLICATORI DI AGRAPHES H020304 4 NO ROBOTIC SURGERY STAPLERS SUTURATRICI PER CHIRURGIA ROBOTICA H02030401 5 YES ROBOTIC SURGERY LINEAR STAPLERS WITH STANDARD TIP SUTURATRICI PER CHIRURGIA ROBOTICA LINEARI CON PUNTA STANDARD H02030402 5 YES ROBOTIC SURGERY LINEAR STAPLERS WITH CURVED TIP SUTURATRICI PER CHIRURGIA ROBOTICA LINEARI CON PUNTA CURVA H02030403 5 YES ROBOTIC SURGERY STAPLER RELOADS RICARICHE PER SUTURATRICI PER CHIRURGIA ROBOTICA H02030499 5 YES ROBOTIC SURGERY STAPLERS - OTHER SUTURATRICI PER CHIRURGIA ROBOTICA - ALTRE H020380 4 YES STAPLERS, VIDEOSURGERY - ACCESSORIES SUTURATRICI PER VIDEOCHIRURGIA - ACCESSORI H020399 4 YES STAPLERS, VIDEOSURGERY - OTHER SUTURATRICI PER VIDEOCHIRURGIA - ALTRE [bookmark: _Toc1891568161][bookmark: _Toc236388372]ID 1568 - RESPIRATORY THERAPY AIDS [bookmark: _Toc1749877962][bookmark: _Toc236388373]REQUESTS DETAILS ID EMDN \Category EMDN Group EMDN Code or Reference Type of update Proposal (specify Code XXX – Term XXX) Supporting information 1568 R R90: Respiratory and anaesthesia devices - various R90 INSERT Code R9012 - Term Mechanical positive pressure airway secretion-clearing device (Derived from GMDN 43947) A hand-held, mechanical device designed to remove excessive mucus or sputum (phlegm) from the lungs and upper airway of a patient typically suffering from acute or chronic lung disease. A positive expiratory pressure (PEP) is created when a patient exhales into the device, creating vibrations in the chest wall which loosens the mucus for expectoration and also assists in lung expansion. Also known as an oscillating positive expiratory pressure (OPEP) device, it is a single-patient device designed for use both in a healthcare facility and in the home. This is a reusable device. Additional Information received attached or sent upon request · IFU [bookmark: _Toc483784336][bookmark: _Toc236388374]DESCRIPTION OF DEVICE The device is a hand-held, non-powered mechanical instrument designed for airway clearance. It works by creating resistance during exhalation (Positive Expiratory Pressure) paired with vibrations (oscillations) that help mobilize and move excess mucus from the lungs to the upper airways, where it can be coughed out. It is typically intended for single-patient use in the management of chronic respiratory diseases. [bookmark: _Toc1326361382][bookmark: _Toc236388375]OUTCOME PARTIALLY ACCEPTED The request to create a new dedicated code (R9012) was declined in favor of updating the existing term “INSPIRATORY AND EXPIRATORY FLOW STIMULATORS/RESPIRATORY MUSCLES TRAINERS“ of level R900902 NON-POWERED DEVICES FOR INSPIRATORY AND/OR EXPIRATORY FLOW STIMULATION WITH POSITIVE EXPIRATORY PRESSURE (PEP) AND/OR RESPIRATORY MUSCLE TRAINING (RMT) FUNCTIONS. Rationale: Based on a comprehensive evaluation—encompassing a technical review of the action mechanism (PEP combined with high-frequency oscillations), keyword research in Medical Device Databases, and a taxonomic comparison within the R90 group. It was revealed that manufacturers already frequently associate these devices with level R900902. Although the previous term focused on rehabilitation and muscle training, the analysis confirmed it lacked an explicit reference to airway secretion clearance. Therefore, expanding the existing term was deemed more efficient for EMDN stability than creating a new terminal level. The addition of "Non-powered" was specifically included to prevent confusion with powered equipment used for secretion removal found in other sections of the nomenclature. PROPOSAL CODE LEVEL TERMINAL LEVEL (YES/NO) TERM DESCRIZIONE R90 2 NO RESPIRATORY AND ANAESTHESIA DEVICES - VARIOUS DISPOSITIVI PER APPARATO RESPIRATORIO E ANESTESIA - VARI R9001 3 YES RESPIRATORY MOUTHPIECES BOCCAGLI PER APPARATO RESPIRATORIO R9002 3 YES LARYNGOSCOPE BLADES, SINGLE-USE LAME MONOUSO PER LARINGOSCOPIO R9003 3 NO RESPIRATORY SYSTEM SURGERY INSTRUMENTS, SINGLE-USE STRUMENTARIO PER CHIRURGIA DELL'APPARATO RESPIRATORIO, MONOUSO R9004 3 YES PLEURAL TALCAGE DEVICES DISPOSITIVI PER TALCAGGIO PLEURICO R9005 3 YES ENDOBRONCHIAL VALVES AND RELEASE SYSTEMS VALVOLE ENDOBRONCHIALI E SISTEMI DI RILASCIO R9006 3 NO PHONATION VALVES VALVOLE FONATORIE R9007 3 YES LUNG FUNCTIONALITY TESTING DEVICES, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES DISPOSITIVI PER ESAMI DI FUNZIONALITÀ POLMONARE, MONOUSO - NON COMPRESI IN ALTRE CLASSI R9008 3 YES RESPIRATORY SYSTEM ACTIVE SUBSTANCES SOSTANZE ATTIVE SULL'APPARATO RESPIRATORIO R9009 3 NO RESPIRATORY THERAPY AIDS AUSILI PER LA TERAPIA RESPIRATORIA R900901 4 YES INHALERS INALATORI R900902 4 YES NON-POWERED DEVICES FOR INSPIRATORY AND/OR EXPIRATORY FLOW STIMULATION STIMULATORS/RESPIRATORY MUSCLES TRAINERS WITH POSITIVE EXPIRATORY PRESSURE (PEP) AND/OR RESPIRATORY MUSCLE TRAINING (RMT) FUNCTIONS INCENTIVATORI DEL FLUSSO INSPIRATORIO ED ESPIRATORIO/ALLENATORI DEI MUSCOLI RESPIRATORI DISPOSITIVI NON ALIMENTATI PER LA STIMOLAZIONE DEL FLUSSO INSPIRATORIO E/O ESPIRATORIO CON FUNZIONI DI PEP E/O DI ALLENAMENTO DEI MUSCOLI RESPIRATORI (RMT) R9080 3 YES RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES DISPOSITIVI PER APPARATO RESPIRATORIO E ANESTESIA - ACCESSORI NON COMPRESI IN ALTRE CLASSI R9099 3 YES RESPIRATORY AND ANAESTHESIA DEVICES - OTHER DISPOSITIVI PER APPARATO RESPIRATORIO E ANESTESIA - ALTRI [bookmark: _Toc1628798518][bookmark: _Toc236388376]ID 1540 - URINALS [bookmark: _Toc2006602643][bookmark: _Toc236388377]REQUESTS DETAILS ID EMDN \Category EMDN Code or Reference Type of update Proposal (specify Code XXX – Term XXX) Supporting information 1540 V A060399 INSERT A060305 URINALS We manufacture urinals to collect urine for patients who are unable to use the toilet. We cannot find a suitable code. Additional Information received attached or sent upon request · IFU [bookmark: _Toc950132727][bookmark: _Toc236388378]DESCRIPTION OF DEVICE The device under analysis is a hand-held urinal, which is a portable container designed for patients who are unable to use a toilet for excretory purposes. These devices are typically bulb-shaped or bottle-like, featuring an opening to facilitate urination and often including a handle for easier positioning and emptying. Urinals can be designed specifically for male or female patients or as unisex models. They are manufactured from materials such as polymers (PVC) or metals (stainless steel) and are classified as non-sterile and reusable medical devices. [bookmark: _Toc2017813172][bookmark: _Toc236388379]OUTCOME PARTIALLY ACCEPTED Rationale: The request for a new EMDN code (A060305) for urinals was declined because a technical evaluation and taxonomic review determined that these devices are already covered under the existing level V0812. However, the analysis identified a significant terminological inconsistency: the current English translation of the Italian term "pappagallo" as "parrot" is inconsistent with international medical nomenclature. This finding is supported by database evidence from Medical Device Databases, where keyword searches for "parrot" yielded zero results compared to a consistent number of records for "urinal," confirming that the current nomenclature hinders searchability. Consequently, the request is partially accepted by maintaining code V0812 while updating its English description from "FECES AND URINE COLLECTION AIDS (BED PANS AND PARROTS)" to "FECES AND URINE COLLECTION AIDS (BEDPANS AND URINALS)”. PROPOSAL CODE LEVEL TERMINAL LEVEL (YES/NO) TERM DESCRIZIONE V08 2 NO HEALTHCARE ACTIVITIES SUPPORTIVE EQUIPMENT AND AIDS ATTREZZATURE E AUSILI A SUPPORTO DELL'ATTIVITÀ SANITARIA V0802 3 NO MEDICAL CHAIRS POLTRONE MEDICALI V0803 3 NO MEDICAL CUSHIONS CUSCINI MEDICALI V0804 3 YES PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures) IMMOBILIZZATORI PER PAZIENTI (durante procedure diagnostiche o terapeutiche) V0805 3 NO PATIENT TRANSFER EQUIPMENT ATTREZZATURE PER TRASFERIMENTO DI PAZIENTI V0806 3 NO MEDICAL BEDS LETTI MEDICALI V0807 3 NO ANTI-DECUBITUS MEDICAL MATTRESSES MATERASSI MEDICALI ANTIDECUBITO V0808 3 YES MEDICAL CROSSBARS TRAVERSE MEDICALI V0809 3 YES MANUAL CLINICAL CRIBS FOR NEWBORNS CULLE CLINICHE MANUALI PER NEONATI V0810 3 YES NEWBORN POSITIONERS POSIZIONATORI PER NEONATI V0811 3 YES HEEL, ELBOW AND KNEE ANTI-DECUBITUS PROTECTION AIDS AUSILI DI PROTEZIONE ANTIDECUBITO PER TALLONE, GOMITO E GINOCCHIO V0812 3 YES [bookmark: _Hlk234930694]FECES AND URINE COLLECTION AIDS (BED PANS BEDPANS AND PARROTS URINALS) AUSILI PER LA RACCOLTA DI FECI E URINE (PADELLE E PAPPAGALLI) V0880 3 YES MEDICAL SUPPORT EQUIPMENT - ACCESSORIES ATTREZZATURE DI SUPPORTO ALL'ATTIVITÀ SANITARIA - ACCESSORI V0899 3 YES MEDICAL SUPPORT EQUIPMENT - OTHER ATTREZZATURE DI SUPPORTO ALL'ATTIVITÀ SANITARIA - ALTRE [bookmark: _Toc429219447][bookmark: _Toc236388380]ID 37_2026 - INSULIN PEN INJECTORS [bookmark: _Toc531853643][bookmark: _Toc236388381]REQUESTS DETAILS ID EMDN \Category EMDN Code or Reference Type of update Proposal (specify Code XXX – Term XXX) Supporting information 37_2026 A A99: Devices for administration, withdrawal and collection - other INSERT [bookmark: _Hlk230600377]A99 - INSULIN PEN INJECTORS There are insulin pens on the market that can be refilled with cartridges, which are medical devices. Some pens are even connected, enabling the amount of insulin administered to be tracked electronically. Additional Information received attached or sent upon request Category Details Medical Domain Diabetes Management Indication Subcutaneous insulin delivery for patients with diabetes. Description Insulin pen injectors are portable, easy-to-use devices that allow for accurate and convenient insulin administration. They are available as disposable or reusable pens and are designed to improve patient adherence and quality of life. Materials Plastic, metal, insulin cartridge. Commercial Names NovoPen, FlexPen, KwikPen, InPen [bookmark: _Toc84578087][bookmark: _Toc236388382]DESCRIPTION OF DEVICE Insulin pens are medical devices designed to allow patients with diabetes to self-administer precise doses of insulin subcutaneously. These devices can be disposable (pre-filled, in which case they are considered medicinal products) or reusable (designed to hold insulin cartridges). The most advanced models may include integrated electronic systems (“connected pens”) that allow for the digital tracking and monitoring of the amount of insulin administered. The complete system involves the use of sterile, single-use hypodermic needles that are attached to the pen at the time of injection. [bookmark: _Toc1227141010][bookmark: _Toc236388383]OUTCOME NOT ACCEPTED Rationale: The user manuals and specifications of various commercial models were analyzed, along with the corresponding GMDN definitions for mechanical autoinjectors. The current state of the art of the EMDN nomenclature (v.2026) was reviewed, identifying the existence of the existing code A018006 HYPODERMIC NEEDLES PEN INJECTORS: since the existing level A018006 already technically covers the device’s function, the addition of a new code was deemed redundant. TYPE OF REQUEST CODE SUPPORT INFO RATIONALE EXTENDED RATIONALE INSERT A99 - INSULIN PEN INJECTORS There are insulin pens on the market that can be refilled with cartridges, which are medical devices. Some pens are even connected, enabling the amount of insulin administered to be tracked electronically. [bookmark: _Hlk235182937]The inclusion of new levels is planned to include types of devices not present in the current version of the EMDN (refer to A018006 HYPODERMIC NEEDLES PEN INJECTORS) A018006 HYPODERMIC NEEDLES PEN INJECTORS is appropriate for all types of insulin pen injectors, including reusable models, disposable ones, and those featuring electronic dose-management systems for tracking administration. [bookmark: _Toc389544204][bookmark: _Toc236388384]ID 53_2026 - BLOOD HEATERS FOR DIALYSIS [bookmark: _Toc376547295][bookmark: _Toc236388385]REQUESTS DETAILS ID EMDN \Category EMDN Code or Reference Type of update Proposal (specify Code XXX – Term XXX) Supporting information 53_2026 Z Z12019008 INSERT Z1201900801 - blood heaters for dialysis Used to heat dialysate or blood to body temperature during dialysis to ensure patient comfort and prevent hypothermia. Devices that warm dialysate or blood before it enters the patient’s body during dialysis. They maintain the temperature within a safe and comfortable range. Additional Information received attached or sent upon request Category Details Medical Domain Nephrology, Dialysis Indication Used to heat dialysate or blood to body temperature during dialysis to ensure patient comfort and prevent hypothermia. Description Devices that warm dialysate or blood before it enters the patient’s body during dialysis. They maintain the temperature within a safe and comfortable range. Materials Stainless steel, medical-grade plastics, and heating elements designed for precise temperature control and safety. Commercial Names CAS Medical Device Heaters, Tempco Inline Heaters, Fresenius Medical Care Heaters, Hotline Blood and Fluid Warmer [bookmark: _Toc752068004][bookmark: _Toc236388386]DESCRIPTION OF DEVICE Devices that warm dialysate or blood before it enters the patient’s body during dialysis. They maintain the temperature within a safe and comfortable range. Used to heat dialysate or blood to body temperature during dialysis to ensure patient comfort and prevent hypothermia. [bookmark: _Toc378254090][bookmark: _Toc236388387]OUTCOME NOT ACCEPTED TYPE OF REQUEST  CODE  SUPPORT INFO  RATIONALE  EXTENDED RATIONALE  INSERT  Z1201900801 - blood heaters for dialysis or Z12099008 - blood heaters for dialysis  Used to heat dialysate or blood to body temperature during dialysis to ensure patient comfort and prevent hypothermia. Devices that warm dialysate or blood before it enters the patient’s body during dialysis. They maintain the temperature within a safe and comfortable range.  The inclusion of new levels is planned to include types of devices do not present in the current version of the EMDN.  [bookmark: _Int_UGEDJntN][bookmark: _Int_iV25GnmR]The device is already appropriately classified under Z12030305, as this level already includes dialysis among its intended uses and covers devices for warming and temperature control of medical fluids. While dialysate is not an infusion fluid, in the strict therapeutic sense, the device's function-controlled warming of a medical fluid before patient exposure aligns more closely with this category than with blood heaters or dialysis equipment.  The current limitation is that the wording of Z12019008 refers only to blood warming, making it unsuitable for devices that warm either blood or dialysate. Likewise, Z12090201 is intended for dialysis equipment with integrated warming systems, not standalone warming devices, and Z12040208 is designed for patient body warming through physical contact rather than direct warming of blood or dialysate.  Rather than creating a new classification level, the preferred approach is to update the definition and/or glossary of Z12030305 to explicitly clarify its applicability to devices that warm dialysate. This is a low-risk, low-effort solution that avoids unnecessary reclassification, prevents overlapping between codes, and follows the principle that existing nomenclature should be improved before introducing new terminal codes, which increase long-term maintenance and regulatory complexity.  [bookmark: _Toc233352460] [bookmark: _Toc236388388]ID 1559, ID 1607, ID 48_2026 - OCULAR IMPLANTS [bookmark: _Toc1413709701][bookmark: _Toc236388389]REQUESTS DETAILS ID EMDN \Category- EMDN Code or Reference Type of update Proposal (specify Code XXX – Term XXX) Supporting information 1559 Q A060399- FLUID COLLECTION BAGS AND SYSTEMS - OTHER INSERT Q0212 CILIO-SCLERAL INTERPOSITION DEVICE The device is an implant designed for the treatment of glaucoma. Its main purpose is to reduce intraocular pressure. It is intended to be used in patients suffering from glaucoma to reduce intraocular pressure (IOP) by separating the ciliary body from the sclera, removing an obstacle to the aqueous humor circulation and enhancing the uveoscleral outflow. The difference between this device and those already on the market is the implantation site and therefore the surgical technique (refer to the enclosed IFU). It does not have the same patient profile, performance and safety profile, or the same technology as medical devices classified under the drainage code. It is designed to create a localised space between the ciliary muscle and the sclera, reducing resistance to aqueous flow and improving uveoscleral flow to the choroidal circulation, without the need to open the anterior chamber or disinsert the iris root. 1607 INSERT P0302 - Non-optical endocapsular devices P030201 - Open-capsule endocapsular devices P030202 - Capsular Tension Rings (CTRs) Non-optical endocapsular devices used during cataract surgery have increased in numbers, designs, and most importantly intended purposes. Because of this it becomes imperative to differentiate between two different versions a) open bag endocapsular devices that have similar dimensions as the normal human capsule and maintain capsular shape and intracapsular space improving IOL stability and potentially inhibiting cell migration through more effective peripheral stretching and barrier formation and b) capsular tension rings that have significantly increased diameters than the normal human capsule and aim to redistribute forces from intact zonules to buttress areas of absent weak zonules. 48_2026 NEW P03XX - RING (OPHTALMOLOGY) There are several types of rings used in ophthalmology with different indications : for example, intracorneal rings segments indicated for keratoconus and low myopia, capsular tension rings to prevent capsular bag collapse during cataract surgery and Malyugin rings for managing small pupils (miosis) during cataract surgery. =>It would be relevant to have at least one EMDN code for these devices like “Ring (ophthalmology)”. They are implantable. For information, we have received 18 reports in the last 5 years on rings used in ophtalmology, most of them on Malyugin rings and capsular tension rings. Phrase alternative s'il ne faut pas préciser le nombre d'incidents : "We regularly receive reports of incidents involving this type of device." Additional Information received attached or sent upon request · ID 1559 (INSERT Q0212 CILIO-SCLERAL INTERPOSITION DEVICE): IFU were provided with the update request. · ID 1607 (INSERT P0302 - NON-OPTICAL ENDOCAPSULAR DEVICES, P030201 - OPEN-CAPSULE ENDOCAPSULAR DEVICES, P030202 - CAPSULAR TENSION RINGS (CTRS)): IFU, certificates and scientific literature were provided with the update request. · 48_2026 (NEW P03XX - RING (OPHTALMOLOGY)) After request the following information was provided Category Details Medical Domain Ophthalmology Indication The main medical indication for implantable rings in ophthalmology (specifically intracorneal ring segments, or ICRS) is the treatment of keratoconus, a progressive eye disease that affects the cornea and can lead to significant visual impairment. ICRS are also used for the correction of low myopia and post-LASIK ectasia Description A C-shaped or circular device inserted into the capsular bag to provide mechanical support. These rings are surgically implanted into the corneal stroma—the middle layer of the cornea—to reshape its geometry and improve visual acuity. Materials Polymethacrylate (PMMA), flexible compression-molded materials. Commercial Names Keraring (Mediphacos), Intacs (Addition Technology), Ferrara Ring (Ferrara Ophthalmics), MyoRing (Dioptex) [bookmark: _Toc1534744352][bookmark: _Toc236388390]DESCRIPTION OF DEVICES · [bookmark: _Toc236388391]ID 1559 (INSERT Q0212 CILIO-SCLERAL INTERPOSITION DEVICE) The device is a tiny, flexible permanent insert designed for patients with glaucoma. It is surgically placed into a specific gap in the eye (between the ciliary muscle and the sclera) to act as a physical "prop." This keeps a natural drainage pathway open, allowing excess fluid to flow out of the eye, which reduces internal pressure and protects the patient's vision. Because the device is a permanent structural implant rather than a temporary tool, the analysis determined it should be moved from the general ophthalmology category (Category Q) to Ocular Prostheses (Category P). The term was updated to "Spacer" to precisely describe its mechanical function of maintaining anatomical space. · [bookmark: _Toc236388392]ID 1607 (INSERT P0302 - NON-OPTICAL ENDOCAPSULAR DEVICES, P030201 - OPEN-CAPSULE ENDOCAPSULAR DEVICES, P030202 - CAPSULAR TENSION RINGS (CTRS)) These devices are structural supports placed deep inside the eye, specifically within the "capsular bag"— the natural pocket that holds the eye's lens. They are used during cataract surgery as a permanent mechanical foundation to keep that pocket open and stable, ensuring that the new artificial lens (IOL) stays perfectly centered. The technical review focused on the mechanical role of these devices, distinguishing them from lenses that provide vision. This led to the need of the creation of the specific group P0302 "Endocapsular non-optical supports". The scope was also expanded to include both Capsular Tension Rings (CTR) and Segments (CTS) to cover all mechanical stabilization types identified in the market · [bookmark: _Toc236388393]ID 48_2026 (NEW P03XX - RING (OPHTALMOLOGY)) These devices are microscopic corrective inserts placed near the surface of the eye, within the thickness of the cornea. Unlike the supports used inside the lens pocket, these act as "reshapers" that physically change the curvature of the cornea. They are essential for smoothing out eyes deformed by conditions like keratoconus, effectively correcting the patient's vision from the outside in. The analysis rejected a generic "Ring" code because it would conflate these refractive surface devices with the deep structural supports mentioned above. To ensure effective vigilance and accurate data retrieval, a dedicated code was created (P030403) that explicitly identifies both rings and segments used within the corneal tissue. [bookmark: _Toc164518368][bookmark: _Toc236388394]OUTCOME PARTIALLY ACCEPTED · [bookmark: _Toc236388395]ID 1559 (INSERT Q0212 CILIO-SCLERAL INTERPOSITION DEVICE) Creation of a new code with a different term and EMDN section (P03 OCULAR PROSTHESES) P0303 SCLERAL AND UVEAL SPACERS FOR AQUEOUS OUTFLOW Rationale: The original term "Cilio-scleral interposition device" was replaced with "Scleral and uveal spacers for aqueous outflow" (P0303): the term "Scleral and Uveal" was introduced to encompass a broader range of devices identified during the analysis that operate on similar biomechanical principles—enhancing uveoscleral flow without using valves or tubes—but are positioned in slightly different anatomical regions within the scleral or cilioscleral space. The term "Spacer" more accurately describes its clinical function of creating and maintaining localized anatomical spaces to facilitate physiological aqueous outflow. The device was relocated from Category Q (General Ophthalmology) to Category P (Ocular Prostheses) because it functions as a permanent structural implant. · [bookmark: _Toc236388396]1607 (INSERT P0302 - NON-OPTICAL ENDOCAPSULAR DEVICES, P030201 - OPEN-CAPSULE ENDOCAPSULAR DEVICES, P030202 - CAPSULAR TENSION RINGS (CTRS)) Creation of a new section P0302, with terms different from the ones proposed. P0302 ENDOCAPSULAR NON-OPTICAL SUPPORTS P030201 OPEN-BAG ENDOCAPSULAR SUPPORTS P030202 CAPSULAR TENSION RINGS (CTRS) AND SEGMENTS (CTS) P030299 ENDOCAPSULAR SUPPORTS – OTHER Rationale: The code P0302 "Endocapsular supports" was created. The term "Devices" was changed to "Supports" to better define their mechanical role: the analysis of technical documentation and manufacturer catalogs (e.g., Morcher) highlighted that these implants are essentially non-optical structural supports used to stabilize the capsular bag’s geometry during or after surgery. The request was expanded to include "Segments (CTS)" alongside "Capsular Tension Rings (CTR)": This was necessary because CTS are used for localized zonular reinforcement rather than global redistribution, and their inclusion ensures that all types of endocapsular non-optical supports are specifically accounted for within the same hierarchy. · [bookmark: _Toc236388397]ID 48_2026 (NEW P03XX - RING (OPHTALMOLOGY)) Creation of a new code with a different term P0304 INTRACORNEAL RING IMPLANTS (RINGS AND SEGMENTS) Rationale: the generic proposal "Ring (Ophthalmology)" was rejected in favor of the more specific "Intracorneal ring implants (rings and segments)" (P030403): a single code for "Rings" would be clinically inaccurate as it would conflate devices with vastly different functions and anatomical locations (e.g., capsular tension rings vs. corneal rings). The term "Segments" was explicitly added because data the existence of both corneal segments and full corneal rings. · [bookmark: _Toc236388398]ADDITIONAL PROPOSALS COMING FROM DATABASE ANALYSIS Beyond the specific requests, new levels were introduced to reorganize Category P03 based on identified gaps in the residual code P0399 OCULAR PROSTHESES - OTHER. · P0304 CORNEA NON-OPTICAL IMPLANTS: The analysis of P0399 revealed a significant volume of specific devices, including Keratoprostheses and Endothelial corneal implants. Creating a dedicated group (P0304) for these corneal implants—with a "Non-Optical" implied focus to distinguish them from refractive IOLs—prevents the overcrowding of the "Other" category and facilitates data retrieval in EUDAMED. · P0305 PROSTHETIC IRIS RINGS: During the analysis of the Italian database, "Aniridia rings" were identified as a distinct class of device that did not fit into existing groups. Their inclusion provides a specific home for non-optical implants used for iris reconstruction, which were previously lost in residual classifications. PROPOSAL CODE LEVEL TERMINAL LEVEL (YES/NO) TERM DESCRIZIONE P03 2 NO OCULAR PROSTHESES PROTESI OCULISTICHE P0301 3 NO INTRAOCULAR LENSES (IOL) LENTI INTRAOCULARI P030101 4 NO IOLs, PHAKIC LENTI PER FACHICI P030102 4 NO IOLs, APHAKIC LENTI PER AFACHICI P030190 4 NO INTRAOCULAR LENSES (IOL) - VARIOUS LENTI INTRAOCULARI - VARIE P030199 4 YES INTRAOCULAR LENSES (IOL) - OTHER LENTI INTRAOCULARI - ALTRE P0302 3 NO ENDOCAPSULAR NON-OPTICAL SUPPORTS SUPPORTI ENDOCAPSULARI NON OTTICI P030201 4 YES OPEN-BAG ENDOCAPSULAR SUPPORTS SUPPORTI ENDOCAPSULARI OPEN-BAG P030202 4 YES CAPSULAR TENSION RINGS (CTRS) AND SEGMENTS (CTS) ANELLI DI TENSIONE CAPSULARI (CTR) E SEGMENTI (CTS) P030299 4 YES ENDOCAPSULAR SUPPORTS - OTHER SUPPORTI ENDOCAPSULARI - ALTRI P0303 3 YES SCLERAL AND UVEAL SPACERS FOR AQUEOUS OUTFLOW SPAZIATORI SCLERALI E UVEALI PER DEFLUSSO DELL’UMOR ACQUEO P0304 3 NO CORNEA NON-OPTICAL IMPLANTS IMPIANTI CORNEALI NON OTTICI P030401 4 YES KERATOPROSTHESES (ARTIFICIAL CORNEA) CHERATOPROTESI (CORNEE ARTIFICIALI) P030402 4 YES ENDOTHELIAL CORNEAL IMPLANTS IMPIANTI CORNEALI ENDOTELIALI P030403 4 YES INTRACORNEAL RING IMPLANTS (RINGS AND SEGMENTS) IMPIANTI AD ANELLO INTRACORNEALI (ANELLI E SEGMENTI) P030499 4 YES CORNEA IMPLANTS - OTHER IMPIANTI CORNEALI - ALTRI P0305 3 YES PROSTHETIC IRIS RINGS ANELLI PROTESICI IRIDEI P0380 3 YES OCULAR PROSTHESES - ACCESSORIES PROTESI OCULISTICHE - ACCESSORI P0399 3 YES OCULAR PROSTHESES - OTHER PROTESI OCULISTICHE - ALTRE [bookmark: _Toc553269079][bookmark: _Toc236388399]ID 16_2026, ID 17_2026, ID 18_2026 - PARASITOLOGY IMMUNOASSAY [bookmark: _Toc1740433686][bookmark: _Toc236388400]REQUESTS DETAILS ID EMDN \Category- EMDN Code or Reference Type of update Proposal (specify Code XXX – Term XXX) Supporting information 16_2026 W NEW W0105050211 - Trichinella spiralis There is no specific code for Trichinella spiralis antibody tests, althrough there is IVDR reagents. 17_2026 W NEW W0105050212 - Taeniasis / cysticercosis There is no specific code for taeniasis antibody tests, althrough there is IVD reagents. 18_2026 W NEW W0105050213 - Toxocara canis There is no specific code for Toxocara canis antibody tests, althrough there is IVD reagents. Additional Information received attached or sent upon request Some additional details received after request. [bookmark: _Toc1238045222][bookmark: _Toc236388401]DESCRIPTION OF DEVICE · [bookmark: _Toc236388402]ID 16_2026 (INSERT W0105050211 - Trichinella spiralis) These devices are in vitro diagnostic (IVD) serological tests, such as ELISA or immunoblot (Western Blot) assays, designed for the qualitative detection of IgG antibodies against the parasitic nematode Trichinella spiralis in biological samples. They are primarily utilized as confirmatory tests following positive or equivocal results obtained from standard screening assays. · [bookmark: _Toc236388403]ID 17_2026 (INSERT W0105050212 - Taeniasis / cysticercosis) These are serological tests (ELISA or Western Blot) intended for the detection of antibodies against Taenia solium in serum or cerebrospinal fluid (CSF). These assays serve as a critical diagnostic aid for both taeniasis and cysticercosis. · [bookmark: _Toc236388404]ID 18_2026 (INSERT W0105050213 - Toxocara canis) These devices are immunoenzymatic (ELISA) or immunoblot assays designed for the qualitative or quantitative detection of IgG antibodies against Toxocara canis larvae in human serum or plasma. [bookmark: _Toc1285861949][bookmark: _Toc236388405]OUTCOME · [bookmark: _Toc236388406]ID 16_2026 (INSERT W0105050211 - Trichinella spiralis) ACCEPTED Rationale: The request was accepted as the evidence emerged from a technical review of the Instructions for Use (IFU) and a comparison with GMDN terminology for Trichinella antibody kits confirmed the necessity for the insertion of a dedicated level. Furthermore, extensive searches in Medical Device databases identified that several specific products are currently registered under generic "Other" categories (specifically W0105050299) due to the lack of dedicated nomenclature. The creation of the new terminal code W0105050211 ensures these reagents are accurately classified, improving taxonomic clarity and regulatory searchability. · [bookmark: _Toc236388407]ID 17_2026 (INSERT W0105050212 - Taeniasis / cysticercosis) PARTIALLY ACCEPTED Rationale: the request was partially accepted based on a review of the technical documentation, alongside a taxonomic comparison with other international nomenclatures for Taenia solium antigen and antibody IVDs. This evaluation, supported by database research, confirmed a significant volume of registrations for these devices that were previously lacking a specific classification level, justifying the necessity for a dedicated code. However, the original proposed term was updated to "Taenia solium (cysticercosis)" (code W0105050212) to ensure better alignment with international clinical nomenclature and to more accurately reflect the precise target of the IVD reagents. · [bookmark: _Toc236388408]ID 18_2026 (INSERT W0105050213 - Toxocara canis) ACCEPTED Rationale: the request was accepted as the evaluation—which included an IFU review and verification of existing GMDN terms—alongside regulatory database analysis confirmed the necessity for the insertion of a dedicated level. The evidence identified multiple UDI-DI registrations within the residual category W0105050299 (Parasitology - Other), justifying a more specific terminal classification to accommodate market registrations that previously lacked a precise home in the nomenclature. [bookmark: _Toc236388409]ADDITIONAL PROPOSALS COMING FROM DATABASE ANALYSIS Beyond the specific requests, new levels were introduced based on identified gaps in the residual code W0105050299 PARASITOLOGY – OTHER: W0105050214 ASCARIS W0105050215 FILARIASIS W0105050216 STRONGYLOIDES STERCORALIS W0105050217 ANISAKIDIS PROPOSAL CODE LEVEL TERMINAL LEVEL (YES/NO) TERM DESCRIZIONE W01050502 5 NO MISCELLANEOUS PARASITOLOGY IMMUNOASSAY VARIE PER PARASSITOLOGIA, TEST IMMUNOLOGICI W0105050201 6 YES ENTAMOEBA HISTOLYTICA ENTAMOEBA HISTOLYTICA, ANTICORPI W0105050202 6 YES CHAGAS CHAGAS, ANTICORPI W0105050203 6 YES DISTOMATOSIS DISTOMATOSI, ANTICORPI W0105050204 6 YES ECHINOCOCCUS ECHINOCOCCUS, ANTICORPI W0105050205 6 YES LEISHMANIA LEISHMANIA, ANTICORPI W0105050206 6 YES SCHISTOSOMA SCHISTOSOMA, ANTICORPI W0105050207 6 YES CRYPTOSPORIDIUM CRYPTOSPORIDIUM, ANTICORPI W0105050208 6 YES GIARDIA LAMBLIA GIARDIA LAMBLIA, ANTICORPI W0105050209 6 YES PLASMODIUM (MALARIA) PLASMODIUM MALARIAE, ANTICORPI W0105050210 6 YES TRICHOMONAS TRICHOMONAS, ANTICORPI W0105050211 6 YES TRICHINELLA SPIRALIS TRICHINELLA SPIRALIS, ANTICORPI W0105050212 6 YES TAENIA SOLIUM (CYSTICERCOSIS) TAENIA SOLIUM (CISTICERCOSI), ANTICORPI W0105050213 6 YES TOXOCARA CANIS TOXOCARA CANIS, ANTICORPI W0105050214 6 YES ASCARIS ASCARIS, ANTICORPI W0105050215 6 YES FILARIASIS FILARIASIS, ANTICORPI W0105050216 6 YES STRONGYLOIDES STERCORALIS STRONGYLOIDES STERCORALIS, ANTICORPI W0105050217 6 YES ANISAKIDIS ANISAKIDIS, ANTICORPI W0105050299 6 YES PARASITOLOGY - OTHER TEST DI PARASSITOLOGIA - ALTRI [bookmark: _Toc473677314][bookmark: _Toc236388410]ID 1535 - WALKING AIDS [bookmark: _Toc1057716343][bookmark: _Toc236388411]REQUESTS DETAILS ID EMDN \Category EMDN Code or Reference Type of update Proposal (specify Code XXX – Term XXX) Supporting information 1535 Y Y120399 INSERT Y12030604 - Crutches with handgrip Devices are walking sticks providing support when walking that have a handgrip without a forearm support, a single shaft and one tip (division 12.03.03 of ISO 9999 standard). Additional Information received attached or sent upon request · IFU received with the request. [bookmark: _Toc1341143548][bookmark: _Toc236388412]DESCRIPTION OF DEVICE The devices subject to this request are walking sticks designed to provide support and maintain balance during ambulation. Technically, they are characterized as assistive products featuring a handgrip, a single shaft, and a single tip (ferrule), specifically without forearm support. Construction materials typically include aluminum tubing, handles made of wood or polymers (such as ABS), and synthetic rubber tips. These devices are aids intended for individuals with temporary or permanent reduced mobility due to degenerative conditions, muscle weakness, neuromuscular disorders, or post-operative and post-traumatic recovery. [bookmark: _Toc76109639][bookmark: _Toc236388413]OUTCOME PARTIALLY ACCEPTED Rationale: The request was partially accepted based on a technical evaluation and comparative analysis with the ISO 9999 international standard, which identified these devices as "Walking sticks" (code 12.03.03) rather than "crutches" as originally proposed. Furthermore, comprehensive searches in the Medical Device databases confirmed the necessity for the insertion of a dedicated level, revealing that the current residual level (Y120399 - Other) contains huge number of registrations for simple walking sticks or those with integrated seats. To ensure technical accuracy, correct taxonomy, and alignment with international standards, the term "Walking sticks" (Y120301) was adopted instead of the proposed "Crutches with handgrip". [bookmark: _Toc236388414][bookmark: _Hlk235786343]ADDITIONAL PROPOSALS COMING FROM DATABASE ANALYSIS Beyond the specific request, a new level is proposed based on identified gaps in the residual code Y120399 WALKING DEVICES, ONE-HANDED OPERATION – OTHER for "Walking sticks with seat" (Y120302 WALKING STICKS WITH SEAT). PROPOSAL CODE LEVEL TERMINAL LEVEL (YES/NO) TERM DESCRIZIONE Y1203 3 NO WALKING DEVICES, ONE-HANDED OPERATION AUSILI PER LA DEAMBULAZIONE UTILIZZATI CON UN BRACCIO Y120301 4 YES WALKING STICKS BASTONI PER DEAMBULAZIONE Y120302 4 YES WALKING STICKS WITH SEAT BASTONI PER DEAMBULAZIONE CON SEDILE Y120303 4 YES WHITE STICKS FOR BLIND PERSONS BASTONI PER NON VEDENTI Y120306 4 NO WALKING CRUTCHES STAMPELLE Y12030601 5 YES ELBOW CRUTCHES STAMPELLE CANADESI Y12030602 5 YES CRUTCHES WITH ANTIBRACHIAL SUPPORT STAMPELLE CON APPOGGIO ANTIBRACHIALE Y12030603 5 YES CRUTCHES WITH UNDER-AXLE SUPPORT STAMPELLE CON APPOGGIO SOTTOASCELLARE Y120315 4 YES TRIPODS TRIPODI Y120318 4 YES QUADRIPODS QUADRIPODI Y120380 4 YES ONE ARM MANIPULATED WALKING AIDS - ACCESSORIES AUSILI PER LA DEAMBULAZIONE UTILIZZATI CON UN BRACCIO - ACCESSORI Y120399 4 YES WALKING DEVICES, ONE-HANDED OPERATION - OTHER AUSILI PER LA DEAMBULAZIONE UTILIZZATI CON UN BRACCIO - ALTRI [bookmark: _Toc1586653637][bookmark: _Toc236388415]ID 1550 - SIGNALLING AIDS [bookmark: _Toc2068343818][bookmark: _Toc236388416]REQUESTS DETAILS ID EMDN \Category EMDN Code or Reference Type of update Proposal (specify Code XXX – Term XXX) Supporting information 1550 Y  Y2409 INSERT Y2409XX CONTROL DEVICES IN BED Cover that detects whether or not a patient is in bed - alerts the caregiver if the resident is absent (e.g. in the event of a fall) Additional Information received attached or sent upon request · IFU received with the request. [bookmark: _Toc235555167][bookmark: _Toc236388417]DESCRIPTION OF DEVICE The device subject to this request is a connected bed cover designed to monitor a patient's position and activity while in bed. Technically, it functions as a monitoring system that detects the presence or absence of a resident and triggers an alert to caregivers in the event of risky situations, such as involuntary bed exits, wandering, or potential falls. These devices are primarily intended for medical monitoring of dependent or disabled individuals and serve as a non-physical alternative to restraints for patients with behavioral disorders or confusional syndromes. [bookmark: _Toc1605018702][bookmark: _Toc236388418]OUTCOME PARTIALLY ACCEPTED Rationale: The request was partially accepted based on a technical evaluation which determined that the original proposal to place the device under category Y2409 (Object Manipulation Devices) was taxonomically incorrect, as these monitoring devices do not serve the purpose of manipulating objects. Instead, the analysis—conducted through a comparative review with the ISO 9999:2022 standard (specifically class 22.29)—identified category Y2151 (Alarm Systems + Signalling, Indication and Reminder Aids) as the appropriate location. This decision was further justified by a comprehensive analysis of UDI-DI registrations in EUDAMED within the residual category Y215199, which confirmed a significant market presence of alarm devices for falls and wandering, confirming the necessity for the insertion of more granular terminal levels. [bookmark: _Toc236388419]ADDITIONAL PROPOSALS COMING FROM DATABASE ANALYSIS Beyond the specific request, new levels are proposed based on identified gaps in the residual code Y215199 ALARM SYSTEMS + SIGNALING, INDICATION AND REMINDER AIDS – OTHER: Y215101 SIGNALLING DEVICES Y215103 ENVIRONMENTAL EMERGENCY ALARM SYSTEMS PROPOSAL CODE LEVEL TERMINAL LEVEL (YES/NO) TERM DESCRIZIONE Y21 2 NO COMMUNICATION AND INFORMATION MANAGEMENT AIDS AUSILI PER LA COMUNICAZIONE E LA GESTIONE DELL’INFORMAZIONE … … … … … Y2151 3 NO ALARM SYSTEMS + SIGNALLING, INDICATION AND REMINDER AIDS SISTEMI DI ALLARME E AUSILI DI SEGNALAZIONE, INDICAZIONE E PROMEMORIA Y215101 4 YES SIGNALLING DEVICES AUSILI PER LA SEGNALAZIONE Y215102 4 YES PERSONAL EMERGENCY ALARM SYSTEMS AUSILI PER ALLARME PER LA SICUREZZA PERSONALE Y215103 4 YES ENVIRONMENTAL EMERGENCY ALARM SYSTEMS AUSILI PER ALLARME AMBIENTALE DI SICUREZZA Y215112 4 YES CLOCKS FOR PERSONS WITH DISABILITIES OROLOGI PER DISABILI Y215199 4 YES ALARM SYSTEMS + SIGNALING, INDICATION AND REMINDER AIDS - OTHER SISTEMI DI ALLARME E AUSILI DI SEGNALAZIONE, INDICAZIONE E PROMEMORIA - ALTRI [bookmark: _Toc702606923][bookmark: _Toc236388420]ID 1543, ID 1544, ID 1547 – BED AND WHEELCHAIR MOBILITY RESTRAINT [bookmark: _Toc352555672][bookmark: _Toc236388421]REQUESTS DETAILS ID EMDN \Category EMDN Code or Reference Type of update Proposal (specify Code XXX – Term XXX) Supporting information 1543 V V080680 INSERT V08068004 BELTS FOR MEDICAL BEDS Bed restraint belt 1544 V V080680 INSERT V08068005 IMMOBILIZER SPLINT IN BED Arm or leg immobilisation rails when the patient is lying in bed 1547 Y Y1224 INSERT Y1224XX WRIST STRAP Wrist strap for wheelchair Additional Information received attached or sent upon request · Request attachments: IFUs; · Additional info by email: IFUs and sales Brochure; [bookmark: _Toc114653077][bookmark: _Toc236388422]DESCRIPTION OF DEVICE · ID 1543: Belt used to limit the risk of patients falling from bed, reduce risks related to wandering and prevent inappropriate movements during exams or recovery. They allow for various degrees of immobilization, including dorsal or lateral positioning. For instance, certain models allow the patient to move laterally in a controlled manner or remain fixed depending on how the side straps are adjusted to the bed post. [image: ] · ID 1544: devices designed to support and limit the movement of a specific limb while the patient is in bed. The arm or leg is laced onto the padded gutter and secured with self-fastening straps. They can be used on either the left or right side and are suitable for use with other supports or casts, even allowing for passive exercise of the limb. [image: ] · ID 1547: devices attached around the patient’s wrists and secured to the wheelchair armrests to restrict movement and prevent injury from pulling attempts. They are made from comfortable, padded fabric or neoprene to prevent skin lesions, friction, and bruising. The straps are typically secured around the wrist with self-fastening material and then attached to the wheelchair support using a quick-release fastener. [image: ] [bookmark: _Toc369286830][bookmark: _Toc236388423]OUTCOME NOT ACCEPTED There is no evidence that these devices are used exclusively in conjunction with medical beds or wheelchairs. The EMDN already includes a specific level for 'Patient immobilisers (in diagnostic or therapeutic procedures)' - V0804. TYPE OF REQUEST CODE SUPPORT INFO RATIONALE EXTENDED RATIONALE INSERT V080680 - MEDICAL BEDS - ACCESSORIES Bed restraint belt The inclusion of new levels is planned to include types of devices not present in the current version of the EMDN [refer to V0804 PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)] Under EMDN principles, a specialized level is justified only when a clear technical gap is identified that cannot be addressed by existing classifications. Following technical evaluation, the evidence does not sufficiently substantiate that the device’s intended purpose is strictly limited to integration with medical beds. INSERT V080680 - MEDICAL BEDS - ACCESSORIES Arm or leg immobilisation rails when the patient is lying in bed The inclusion of new levels is planned to include types of devices not present in the current version of the EMDN [refer to V0804 PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)] Under EMDN principles, a specialized level is justified only when a clear technical gap is identified that cannot be addressed by existing classifications. Following technical evaluation, the evidence does not sufficiently substantiate that the device’s intended purpose is strictly limited to integration with medical beds. INSERT Y1224 - WHEELCHAIR ACCESSORIES Y1224XX WRIST STRAP Wrist strap for wheelchair The inclusion of new levels is planned to include types of devices not present in the current version of the EMDN [refer to V0804 PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures) Under EMDN principles, a specialized level is justified only when a clear technical gap is identified that cannot be addressed by existing levels. Following technical evaluation, the evidence does not sufficiently substantiate that the device’s intended purpose is exclusively restricted to wheelchair integration; therefore, it could fall under level V0804. [bookmark: _Toc972559171][bookmark: _Toc236388424]ID 1545 – ARM SUPPORT SLINGS [bookmark: _Toc1817966722][bookmark: _Toc236388425]REQUESTS DETAILS ID EMDN \Category EMDN Code or Reference Type of update Proposal (specify Code XXX – Term XXX) Supporting information 1545 Y Y09 INSERT Y0901 SUPPORT SLING Arm support sling Additional Information received attached or sent upon request · Request attachments: IFUs; · Additional info by email: IFUs and sales Brochure; [bookmark: _Toc43053399][bookmark: _Toc236388426]DESCRIPTION OF DEVICE Device designed to support the upper limb and limit its movement without strictly immobilizing the shoulder. It is primarily used to provide stability and relief in cases of wrist or forearm fractures. The device typically consists of a sleeve where the arm is rested and a strap that passes over the shoulder to distribute the weight of the limb. [image: ] [bookmark: _Toc569989810][bookmark: _Toc236388427]OUTCOME NOT ACCEPTED An EMDN level is already available for this device: SHOULDER-ELBOW ORTHESES - Y060624 TYPE OF REQUEST CODE SUPPORT INFO RATIONALE EXTENDED RATIONALE INSERT Y09 - PERSONAL CARE AIDS Y0901 SUPPORT SLING The inclusion of new levels is planned to include types of devices not present in the current version of the EMDN [refer to Y060624 SHOULDER-ELBOW ORTHESES] Under the principles of the EMDN, a specialized level is justified only when a clear technical gap is identified that cannot be addressed by existing levels. Upon technical evaluation, the documentation provided does not identify a specific technical gap or a degree of innovation that justifies the creation of a more detailed level. Moreover, section Y09 is designed for devices such as body protection, incontinence products, and hygiene aids. Since the device's characteristics do not align with the functional scope of this group, there is insufficient evidence to validate the integration of a new level in this location. [bookmark: _Toc2090322847][bookmark: _Toc236388428]ID 1548 – ANTI-SLIP SYSTEMS [bookmark: _Toc1482870033][bookmark: _Toc236388429]REQUESTS DETAILS ID EMDN \Category EMDN Code or Reference Type of update Proposal (specify Code XXX – Term XXX) Supporting information 1548 Y Y1224 INSERT Y1224XX ANTI-SLIP SYSTEM Anti-slip system positioned around the cushion installed on the wheelchair Additional Information received attached or sent upon request · Request attachments: IFUs; · Additional info by email: IFUs and sales Brochure; [bookmark: _Toc1146094613][bookmark: _Toc236388430]DESCRIPTION OF DEVICE The device is an anti-slip system designed to be fitted to wheelchairs to prevent patients from falling. It consists of a square rough mesh to be positioned under the seated patient. [image: ][image: ] [bookmark: _Toc1152142526][bookmark: _Toc236388431]OUTCOME PARTIALLY ACCEPTED Since there is no evidence that these devices are used exclusively with wheelchairs, the analysis did not find it suitable to classify them under 'Wheelchair accessories'. Furthermore, several other devices specifically intended for slip prevention were identified. Because these products are used both at home and in healthcare facilities (such as in combination with medical beds) and currently lack a dedicated classification, we propose adding a new level under V90 (Various devices not included in other classes) rather than under Y1224 as requested: V9019 – SLIP PREVENTION AIDS PROPOSAL CODE LEVEL TERMINAL LEVEL (YES/NO) TERM DESCRIZIONE V90 2 NO VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES DISPOSITIVI VARI NON COMPRESI IN ALTRE CLASSI … … … … … V9017 3 YES ORAL ADMINISTRATION PREPARATIONS NOT INCLUDED IN OTHER CLASSES PREPARATI PER SOMMINISTRAZIONE ORALE NON COMPRESI IN ALTRE CLASSI V9018 3 YES TRICHOTOMY MANUAL DEVICES DISPOSITIVI MANUALI PER TRICOTOMIA V9019 3 YES SLIP PREVENTION AIDS AUSILI PER LA PREVENZIONE DELLO SCIVOLAMENTO V9099 3 YES VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER DISPOSITIVI VARI NON COMPRESI IN ALTRE CLASSI - ALTRI [bookmark: _Toc1132291152][bookmark: _Toc236388432]ID 1574, ID 32_2026 - NEUROVASCULAR STENTS [bookmark: _Toc2115543497][bookmark: _Toc236388433]REQUESTS DETAILS ID EMDN \Category EMDN Code or Reference Type of update Proposal (specify Code XXX – Term XXX) Supporting information 1574 P P070402 INSERT P07040203-NEUROVASCULAR STENTS P0704020301-NEUROVASCULAR BARE METAL STENTS P0704020302-NEUROVASCULAR COVERED STENTS P0704020303-NEUROVASCULAR COATED STENTS P0704020304-NEUROVASCULAR DRUG ELUTING STENTS This device is a high-risk neurovascular medical device Manufacturer, based in Singapore. Our products are novel neuro flow diverters- the metal stent is covered by a proprietary polymer. The polymer region forms the working length of the implant. The polymer is then laser drilled, to provide the higher surface coverage (58%) than a typical neuro flow diverter (30-40%). The products are intended to occlude the targeted intracranial aneurysm located in the Internal Carotid Artery (ICA) by diverting the blood flow away from the aneurysm neck and reconstructing the parent artery. The porosity of the polymer helps in the flow diversion from the aneurysm while keeping the side branches perfused. Attached is the IFU of our latest product which is under MDR Conformity Evaluation. We could not find the most appropriate term for our device while searching for the relevant EMDN code. 32_2026 P P07 - Vascular and cardiac prostheses INSERT P07040203 - INTRACRANIAL VASCULAR STENT There is a requirement to establish a new EMDN code specifically for intracranial vascular stents used in neurovascular applications within interventional neuroradiology. At present, the closest available code is EMDN P070402 “vascular stents”, which covers coronary stents (P07040201) and peripheral cardiac stents (P07040202), but does not include intracranial vascular stents. We propose adding a new, highly specific EMDN code under Category P: P07040203 INTRACRANIAL VASCULAR STENT, reserved exclusively for neurovascular use. For reference, the corresponding GMDN code for intracranial vascular stents is 46352 “Bare-metal intracranial vascular stent”. Additional Information received attached or sent upon request · [bookmark: _Toc236388434]ID 1574 (INSERT P07040203-NEUROVASCULAR STENTS) IFU, Reference to other nomenclatures · [bookmark: _Toc236388435]ID 32_2026 (INSERT P07040203 - INTRACRANIAL VASCULAR STENT) Category Details Medical Domain Neurology, Interventional Neuroradiology Indication Treatment of intracranial aneurysms and stenosis to restore and maintain cerebral blood flow. Description Self-expanding stents designed for precise deployment within intracranial vessels, providing scaffold support and promoting endothelialization. Materials Nitinol, platinum, medical-grade polymers. Commercial Names Neuroform Atlas Stent (Stryker), LVIS Jr. Device (MicroVention), Enterprise Vascular Reconstruction Device (Cerenovus). [bookmark: _Toc1938963479][bookmark: _Toc236388436]DESCRIPTION OF DEVICE · [bookmark: _Toc236388437]ID 1574 (INSERT P07040203-NEUROVASCULAR STENTS) The device subject is a neurovascular covered stent, technically functioning as a flow diverter, designed for the endovascular treatment of intracranial aneurysms and carotid cavernous fistulas. It consists of a self-expandable Nitinol stent frame integrated with a microporous polymer membrane that significantly reduces the permeability of the underlying structure. By acting as a specialized neurovascular stent, it is intended to exclude aneurysms from arterial circulation by diverting blood flow away from the aneurysm neck while maintaining patency in adjacent vessel branches. · [bookmark: _Toc236388438]ID 32_2026 (INSERT P07040203 - INTRACRANIAL VASCULAR STENT) Intracranial vascular stents are self-expanding tubular implantable devices, typically manufactured from Nitinol (nickel-titanium alloy) with open-cell or closed-cell configurations. They are specifically engineered for low-profile delivery and high conformability within small, tortuous cerebral vessels. These stents are primarily utilized as adjunctive devices in interventional neuroradiology to treat intracranial aneurysms (e.g., wide-neck aneurysms) by providing vessel reconstruction and mechanical support for embolization materials like coils, or to restore and maintain blood flow in cases of stenosis or acute ischemic stroke. [bookmark: _Toc1267970623][bookmark: _Toc236388439]OUTCOME · [bookmark: _Toc236388440]ID 1574 (INSERT P07040203-NEUROVASCULAR STENTS) PARTIALLY ACCEPTED Rationale: The request was partially accepted based on a technical evaluation aimed at establishing a granular classification for the neurovascular stent market—including bare metal, covered, coated, and drug-eluting versions—and a comprehensive search in Medical Device database. This analysis confirmed a substantial market presence specifically for neurovascular and intracranial stents, and identified significant clusters of bare metallic stents, surface-treated/antithrombogenic stents, and polymer-coated versions. Consequently, the final proposal was restructured to align with these identified market types: Neurovascular bare metallic stents (BMS), Neurovascular coated metallic stents, and Neurovascular surface-treated metallic stents. The "drug-eluting" level was excluded as no supporting evidence for such neurovascular devices was found in the analysed databases or manufacturer technical documentation. · [bookmark: _Toc236388441]ID 32_2026 (INSERT P07040203 - INTRACRANIAL VASCULAR STENT) PARTIALLY ACCEPTED Rationale: The evidence emerged from the database analysis confirmed the necessity for the insertion of a dedicated level for intracranial vascular stents, which previously lacked a specific classification in Category P07. The creation of the new section P07040203 NEUROVASCULAR STENTS ensures taxonomic clarity. · [bookmark: _Toc236388442]ADDITIONAL PROPOSAL COMING FROM EVALUATIONS In conjunction with the introduction of the level P0704020303 - NEUROVASCULAR SURFACE-TREATED METALLIC STENTS, a technical assessment was performed to ensure terminological consistency across the vascular stent hierarchy. The analysis verified that the term "BIOACTIVE" (BIOATTIVI), currently employed in levels P0704020105 (Coronary Stents) and P0704020204 (Peripheral Vascular Stents), must be replaced. The review of devices associated with these levels confirmed that substituting "BIOACTIVE" with "SURFACE-TREATED" provides a more accurate and harmonized description of the technological characteristics of these stents. This modification aligns the coronary and peripheral categories with the newly established neurovascular terminology, ensuring a uniform taxonomic logic for all vascular devices featuring specialized surface modifications. PROPOSAL CODE LEVEL TERMINAL LEVEL (YES/NO) TERM DESCRIZIONE P070402 4 NO VASCULAR STENTS STENT VASCOLARI P07040201 5 NO CORONARY STENTS STENT CORONARICI P0704020101 6 NO CORONARY BARE METAL STENTS (BMS) STENT CORONARICI NUDI (BMS) P070402010101 7 YES STAINLESS STEEL CORONARY BARE METAL STENTS (BMS) STENT CORONARICI NUDI IN ACCIAIO P070402010102 7 YES METALLIC NON-STAINLESS STEEL CORONARY STENTS STENT CORONARICI NUDI IN LEGHE METALLICHE DIVERSE DALL'ACCIAIO P070402010199 7 YES CORONARY BARE METAL STENTS (BMS) - OTHER STENT CORONARICI NUDI (BMS) - ALTRI P0704020102 6 YES COATED CORONARY STENTS STENT CORONARICI RIVESTITI P0704020103 6 NO CORONARY DRUG ELUTING STENTS (DES) STENT CORONARICI A CESSIONE DI FARMACO (DES) P070402010301 7 YES CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS STENT CORONARICI A CESSIONE DI FARMACO CON POLIMERI P070402010302 7 YES CORONARY DRUG ELUTING STENTS (DES) WITHOUT POLYMERS STENT CORONARICI A CESSIONE DI FARMACO SENZA POLIMERI P0704020104 6 YES CORONARY STENTS, ABSORBABLE STENT CORONARICI RIASSORBIBILI P0704020105 6 YES CORONARY STENTS, BIOACTIVE SURFACE-TREATED STENT CORONARICI BIOATTIVI P0704020199 6 YES CORONARY STENTS - OTHER STENT CORONARICI - ALTRI P07040202 5 NO PERIPHERAL VASCULAR STENTS STENT VASCOLARI PERIFERICI P0704020201 6 NO PERIPHERAL VASCULAR STENTS, BMS STENT VASCOLARI PERIFERICI NUDI (BMS) P070402020101 7 YES STAINLESS STEEL PERIPHERAL VASCULAR BARE METAL STENTS STENT VASCOLARI PERIFERICI NUDI IN ACCIAIO P070402020102 7 YES NON-STAINLESS STEEL PERIPHERAL VASCULAR BARE METAL STENTS STENT VASCOLARI PERIFERICI NUDI IN LEGHE METALLICHE DIVERSE DALL'ACCIAIO P070402020199 7 YES PERIPHERAL VASCULAR BARE STENTS - OTHER STENT VASCOLARI PERIFERICI NUDI - ALTRI P0704020202 6 YES PERIPHERAL VASCULAR COATED STENTS STENT VASCOLARI PERIFERICI RIVESTITI P0704020203 6 YES PERIPHERAL VASCULAR DRUG ELUTING STENTS (DES) STENT VASCOLARI PERIFERICI A CESSIONE DI FARMACO (DES) P0704020204 6 YES PERIPHERAL VASCULAR STENTS, BIOACTIVE SURFACE-TREATED STENT VASCOLARI PERIFERICI BIOATTIVI P0704020299 6 YES PERIPHERAL VASCULAR STENTS - OTHER STENT VASCOLARI PERIFERICI - ALTRI P07040203 5 NO NEUROVASCULAR STENTS STENT NEUROVASCOLARI P0704020301 6 YES NEUROVASCULAR BARE METALLIC STENTS (BMS) STENT NEUROVASCOLARI METALLICI NUDI (BMS) P0704020302 6 YES NEUROVASCULAR COATED METALLIC STENTS STENT NEUROVASCOLARI METALLICI RIVESTITI P0704020303 6 YES NEUROVASCULAR SURFACE-TREATED METALLIC STENTS STENT NEUROVASCOLARI METALLICI CON TRATTAMENTO SUPERFICIALE P0704020399 6 YES NEUROVASCULAR STENTS - OTHER STENT NEUROVASCOLARI - ALTRI [bookmark: _Toc316192866][bookmark: _Toc236388443]ID 25_2026 – STERNAL PROSTHESES [bookmark: _Toc644802751][bookmark: _Toc236388444]REQUESTS DETAILS ID EMDN \Category EMDN Code or Reference Type of update Proposal (specify Code XXX – Term XXX) Supporting information 25_2026  P P09 INSERT  P0915 - STERNAL PROSTHESES In the code P04 (respiratory prostheses), there are only the code for the tracheobronchial prostheses (P0401). It is necessary to add a subcode to introduce this new term STERNAL PROSTHESES (respiratory prostheses or orthopaedic prostesis ?) there is no code EMDN for that type of device, we have some issue with that type of device in France and also in clinical investigation so it is important to distinguish them easily Additional Information received attached or sent upon request · Additional information provided upon request: Category   Details   Medical Domain   Thoracic Surgery, Cardiothoracic Surgery   Indication   Reconstruction and stabilization of the sternum following sternotomy, sternal resection, or trauma.   Description   Customized 3D-printed titanium or titanium alloy prostheses designed to fit the patient’s anatomy, providing rigid support and promoting tissue integration.   Materials   Titanium, titanium alloy, porous polyethylene.   Commercial Names   SternaLock XP (Zimmer Biomet), ARIX STERNAL SYSTEM, Custom 3D-printed sternal prostheses.   [bookmark: _Toc670700040][bookmark: _Toc236388445]DESCRIPTION OF DEVICE These medical devices are intended for the stabilization, fixation, and reconstruction of the anterior chest wall, specifically the sternum and, in some cases, the ribs. They are primarily used in thoracic and cardiothoracic surgery following procedures such as sternotomies or thoracotomies, as well as for treating sternal resections and traumatic fractures. The main objective of these devices is to provide rigid support to the skeletal structure while promoting bone fusion and tissue integration. Two types of devices were subject to analysis. The first type is a system that typically consist of metallic plates and bone screws designed to be fixed onto the frontal portion of the sternum to stabilize bone fragments. Some configurations may also incorporate auxiliary stabilizing components such as cerclage wires, clips, or staples. The second type is 3D-printed implants designed from patient-specific anatomical models (usually based on CT scans). They are used to replace entire sections or parts of the sternum and ribs that have been removed due to tumors or severe trauma [image: ][image: ] [bookmark: _Toc1795714678][bookmark: _Toc236388446]OUTCOME PARTIALLY ACCEPTED Classification under Respiratory Prostheses (P04) is deemed inappropriate, as these devices are intended for chest wall reconstruction and do not involve the respiratory system. Similarly, classification under Orthopaedic Prostheses (P09) is unsuitable, as the sternum and rib cage belong to the medical domain of General Thoracic Surgery rather than orthopaedics. These devices require a distinct safety profile to accommodate respiratory movements and protect underlying organs, which sets them apart from standard orthopaedic implants despite technically being bone fixation plates. Regarding customized 3D-printed implants, the analysis was significantly constrained by a lack of initial information and the inability to find technical details through extensive research. Therefore, it was not possible to verify their specifics or determine if they should be categorized as patient-matched or custom-made. The proposal entails the creation of a new section, P11 "THORACIC PROSTHESES AND OSTEOSYNTHESIS DEVICES", which includes specific codes for Rib and Sternal Prostheses (P1101), Thoracic Osteosynthesis Devices (P1102), and associated accessories (P1180) or other devices (P1199). To ensure a clear distinction and avoid future confusion, the existing code P0912 has been modified to explicitly include the term "ORTHOPAEDIC". [bookmark: _Toc224622747][bookmark: _Toc236388447]PROPOSAL CODE LEVEL TERMINAL LEVEL (YES/NO) TERM DESCRIZIONE P 1 NO IMPLANTABLE PROSTHETIC AND OSTEOSYNTHESIS DEVICES DISPOSITIVI PROTESICI IMPIANTABILI E MEZZI PER OSTEOSINTESI … … … … … P01 2 NO PROSTHESES, FACIAL, ODONTOLOGICAL, AND CRANIAL PROTESI FACCIALI E ODONTOIATRICHE E CRANICHE … … … … … P02 2 NO ENT PROSTHESES PROTESI OTORINOLARINGOIATRICHE … … … … … P03 2 NO OCULAR PROSTHESES PROTESI OCULISTICHE … … … … … P04 2 NO RESPIRATORY PROSTHESES PROTESI PER APPARATO RESPIRATORIO … … … … … P05 2 NO OESOPHAGEAL AND GASTROINTESTINAL PROSTHESES PROTESI ESOFAGEE E GASTRO-INTESTINALI … … … … … P06 2 NO BREAST IMPLANTS PROTESI MAMMARIE … ... ... … … P07 2 NO VASCULAR AND CARDIAC PROSTHESES PROTESI VASCOLARI E CARDIACHE … ... ... … … P08 2 NO UROGENITAL PROSTHESES PROTESI UROGENITALI … ... ... … … P09 2 NO ORTHOPAEDIC PROSTHESES, OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS PROTESI ORTOPEDICHE E MEZZI PER OSTEOSINTESI E SINTESI TENDINEO-LEGAMENTOSA … ... ... … … P0912 3 NO ORTHOPAEDIC OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS MEZZI PER OSTEOSINTESI ORTOPEDICA E SINTESI TENDINEO-LEGAMENTOSA … ... ... … … P10 2 NO EXTRA-VASCULAR SUPPORT PROSTHESES PROTESI DI SUPPORTO EXTRAVASCOLARE … ... ... … … P11 2 NO THORACIC PROSTHESES AND OSTEOSYNTHESIS DEVICES PROTESI E MEZZI PER OSTEOSINTESI TORACICA P1101 3 YES RIB AND STERNAL PROSTHESES PROTESI DI COSTE E STERNO P1102 3 YES THORACIC OSTEOSYNTHESIS DEVICES MEZZI PER OSTEOSINTESI TORACICA P1180 3 YES THORACIC PROSTHESES AND OSTEOSYNTHESIS DEVICES - ACCESSORIES PROTESI E MEZZI PER OSTEOSINTESI TORACICA - ACCESSORI P1199 3 YES THORACIC PROSTHESES AND OSTEOSYNTHESIS DEVICES - OTHER PROTESI E MEZZI PER OSTEOSINTESI TORACICA - ALTRE P90 2 NO IMPLANTABLE PROSTHETIC AND OSTEOSYNTHESIS DEVICES - VARIOUS DISPOSITIVI PROTESICI IMPIANTABILI E MEZZI PER OSTEOSINTESI - VARI … ... ... … … [bookmark: _Toc2087404108][bookmark: _Toc236388448]ID 1590 - DRILL ATTACHMENTS [bookmark: _Toc2049937592][bookmark: _Toc236388449]REQUESTS DETAILS ID EMDN \Category- EMDN Code or Reference Type of update Proposal (specify Code XXX – Term XXX) Supporting information 1590 Z121390 INSERT Z12139011 - Angular gear A review of the currently existing EMDN codes shows that none accurately reflect the characteristics and intended use of the device. This intended use applies to angular gear, for which no existing code is not appropriate. Using the existing but inaccurate code could lead to misclassification and confusion regarding the device’s actual function, clinical use, and regulatory requirements. Therefore, a new specific code is necessary to ensure clarity and consistency in classification. intended use: A surgical instrument used to transfer force in surgical rotary instruments (e.g. drills). Additional Information received attached or sent upon request Document with product description. [bookmark: _Toc1143902157][bookmark: _Toc236388450]DESCRIPTION OF DEVICE The device is intended to be connected to the motor of a surgical power tool to convert its energy into a drilling motion. [bookmark: _Toc259804848][bookmark: _Toc236388451]OUTCOME NOT ACCEPTED TYPE OF REQUEST CODE SUPPORT INFO RATIONALE EXTENDED RATIONALE INSERT Z12139011 - Angular gear A review of the currently existing EMDN codes shows that none accurately reflect the characteristics and intended use of the device. This intended use applies to angular gear, for which no existing code is not appropriate. Using the existing but inaccurate code could lead to misclassification and confusion regarding the device’s actual function, clinical use, and regulatory requirements. Therefore, a new specific code is necessary to ensure clarity and consistency in classification. intended use: A surgical instrument used to transfer force in surgical rotary instruments (e.g. drills). The inclusion of new levels is planned to include types of devices not present in the current version of the EMDN (refer to Z12130580 MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - HARDWARE ACCESSORIES) The technical assessment indicated that the device is designed for use with specific motorised surgical systems (brand and model), to which it connects in order to transfer the mechanical energy required for the drilling function. Considering the structure of EMDN v.3 and the functional nature of such components, the device appears to fall within the scope of category Z12130580, which covers instruments and hardware components intended for use with motorised orthopaedic surgery systems. [bookmark: _Toc806108261][bookmark: _Toc236388452]ID 1610 - DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS (Polymeric Membrane Dressings) [bookmark: _Toc178813112][bookmark: _Toc236388453]REQUESTS DETAILS ID EMDN \Category EMDN Code or Reference Type of update Proposal (specify Code XXX – Term XXX) Supporting information 1610 M M INSERT Inserting a new level (EMDN code and term) under M0404 (DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS) for polymeric membrane dressings, a device type not currently present in the EMDN. The new code (M040417 POLYMERIC MEMBRANE DRESSINGS), would be in parallel to other equally different wound dressing types (e.g., M040402 ALGINATE DRESSINGS, M040405 HYDROGEL DRESSINGS). I. Background The EMDN classification system is the guide for identifying the appropriate code for medical devices listed in the Eudamed. These codes are chosen by manufacturers, based upon the real-world use of the medical device. Real-world use of the medical device will be driven by the device’s function. Despite being made with relatively few components, polymeric membrane dressings (‘PMDs’) have a carefully orchestrated design which allows PMDs to provide many functions to benefit patients with wounds. Currently, there is no appropriate EMDN code for polymeric membrane dressings. This has proven to be a problem. We chose EMDN codes for our line of PMDs, we and our advisors did not fully recognize the implications of the decision. At the time, we were under the impression that the sole purpose of the codes was for stakeholders, including users and NBs, to be able to find all of our variants in Eudamed. For that purpose, precision is not important. However, We have more recently learned that the EMDN code of a medical device guides major MDR compliance decisions, such as PMCF searches (of country databases of events and recalls and indices of the scholarly literature) for ‘similar’ medical devices, which are defined as devices in the same ‘generic device group’ based upon the first 6 digits of the EMDN). Our inappropriate initial EMDN code choices have created confusion, added to the administrative burden for both us and our notified body, led to significant duplication, and proved to be unintentionally misleading to our NB.* The founders spent 10 years refining the process of making a new wound dressing that could eliminate the excruciating pain children with burns experience at dressing changes. The result of those efforts was the first PMD (see description of polymeric membrane dressings, below). It has been marketed in the EU since 1997 and is approved under the MDD, but not yet under the MDR. MDCG 2018-2 states that the terminology structure of the EMDN, “should not be unnecessarily granular… and should not contain names that are only used by a few… unless it is proven to be advantageous to regulators or the wider healthcare economy…” The advantages of PMDs being listed in Eudamed at the proposed higher level of granularity include making PMDs easier to locate in the tree, allowing all variants of PMDs to have a single code, and allowing PMDs to be compared with truly similar devices for State of the Art.14 The generic name, ‘polymeric membrane dressings’ has been widely used by authors of academic papers in the wound care field, by clinicians who specialize in wound care for over 35 years, and by governments and by organizations that create guidelines documents in the US, the EU, the UK, and the rest of the world. This continues to be the case. Embase’s Emtree indexing system lists PMDs parallel to hydrogels and hydrocolloids. Additional Information received attached or sent upon request · Request attachments: scientific literature, Embase's Emtree for wound dressing, Eudamed Entries with the Same EMDNs as PMDs as of 2026Jan31, document containing a summary of Evidence to Support Adding a New EMDN Code for PMDs [bookmark: _Toc1385029314][bookmark: _Toc236388454]DESCRIPTION OF DEVICE Polymeric membrane dressings made of moisture – loving polyurethane matrix that contains (1) safe wound cleanser, (2) glycerin moisturizer, and (3) superabsorbents. The dressings have a thin polyurethane backing which breathes and helps keep out contamination. These dressings may be used as a combined primary and secondary dressing or as a secondary dressing. This Highly conformable and absorbent dressing in MAX thickness draws wound fluid, which is known to contain natural growth factors and nutrients, to the wound site. [bookmark: _Toc1623976521][bookmark: _Toc236388455]OUTCOME NOT ACCEPTED The current structure of the nomenclature differentiates dressings based on their main material rather than their specific functionality (e.g., swelling or absorbing). Moreover, the subdivision does not account specifically for additional substances. The analysis did not find sufficient evidence to prove a substantial difference between these PMDs and other polyurethane-based foam dressings. The intended use remains the same, and the primary component is still polyurethane foam. Glycerin and surfactants serve as additional components that assist in wound maintenance; however, we found no sufficient evidence indicating that these two components play a role other than auxiliary to the main function of the foam. Furthermore, in the scientific literature (outside of the attached documents provided), these dressings are consistently grouped with other foam dressings and considered comparable. This remains true for both the variation dedicated to cavity wounds and the version containing silver. TYPE OF REQUEST CODE SUPPORT INFO RATIONALE EXTENDED RATIONALE INSERT M: Devices for general and specialist dressings Inserting a new level (EMDN code and term) under M0404 (DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS) for polymeric membrane dressings, a device type not currently present in the EMDN. The new code (M040417 POLYMERIC MEMBRANE DRESSINGS), would be in parallel to other equally different wound dressing types (e.g., M040402 ALGINATE DRESSINGS, M040405 HYDROGEL DRESSINGS). I. Background The EMDN classification system is the guide for identifying the appropriate code for medical devices listed in the Eudamed. These codes are chosen by manufacturers, based upon the real-world use of the medical device. Real-world use of the medical device will be driven by the device’s function. Despite being made with relatively few components, polymeric membrane dressings (‘PMDs’) have a carefully orchestrated design which allows PMDs to provide many functions to benefit patients with wounds. Currently, there is no appropriate EMDN code for polymeric membrane dressings. This has proven to be a problem. We chose EMDN codes for our line of PMDs, we and our advisors did not fully recognize the implications of the decision. At the time, we were under the impression that the sole purpose of the codes was for stakeholders, including users and NBs, to be able to find all of our variants in Eudamed. For that purpose, precision is not important. However, we have more recently learned that the EMDN code of a medical device guides major MDR compliance decisions, such as PMCF searches (of country databases of events and recalls and indices of the scholarly literature) for ‘similar’ medical devices, which are defined as devices in the same ‘generic device group’ based upon the first 6 digits of the EMDN). Our inappropriate initial EMDN code choices have created confusion, added to the administrative burden for both us and our notified body, led to significant duplication, and proved to be unintentionally misleading to our NB.* The founders spent 10 years refining the process of making a new wound dressing that could eliminate the excruciating pain children with burns experience at dressing changes. The result of those efforts was the first PMD (see description of polymeric membrane dressings, below). It has been marketed in the EU since 1997 and is approved under the MDD, but not yet under the MDR. MDCG 2018-2 states that the terminology structure of the EMDN, “should not be unnecessarily granular… and should not contain names that are only used by a few… unless it is proven to be advantageous to regulators or the wider healthcare economy…” The advantages of PMDs being listed in Eudamed at the proposed higher level of granularity include making PMDs easier to locate in the tree, allowing all variants of PMDs to have a single code, and allowing PMDs to be compared with truly similar devices for State of the Art.14 The generic name, ‘polymeric membrane dressings’ has been widely used by authors of academic papers in the wound care field, by clinicians who specialize in wound care for over 35 years, and by governments and by organizations that create guidelines documents in the US, the EU, the UK, and the rest of the world. This continues to be the case. Embase’s Emtree indexing system lists PMDs parallel to hydrogels and hydrocolloids. The insertion of a new term is aimed at include types of devices not present in the current version of the EMDN. If necessary, multiple codes can be assigned to the same UDI-DI. The current EMDN nomenclature categorizes dressings based on their primary constituent material rather than their specific functional properties (e.g., swelling vs. absorbing). There is insufficient evidence to demonstrate a substantial technological or clinical difference from other polyurethane-based foam dressings. [bookmark: _Toc236388456]ID 23_2026 - INTRAMEDULLARY NAILS FOR LIMB LENGTHENING [bookmark: _Toc236388457]REQUESTS DETAILS ID EMDN \Category- EMDN Code or Reference Type of update Proposal (specify Code XXX – Term XXX) Supporting information 23_2026 P P09120299 Osteosyntheses nails - other INSERT LENGTHENING NAIL Regarding the intramedullary nail, a distinction should be introduced to differentiate a nail with a mecanism to lengthen the limbs to a "simple" nail with no mecanism there is no code EMDN for that type of device, We regularly receive reports of incidents involving this type of device Additional Information received attached or sent upon request [bookmark: _Toc226714142] Category Details Medical Domain Orthopedics, Limb Lengthening Indication Treatment of limb length discrepancies, deformity correction, and bone regeneration. Description Internal lengthening device with a magnetic motor, activated by an external remote controller (ERC) to gradually lengthen the bone. Materials Titanium alloy, magnetic motor, medical-grade coin batteries. Commercial Names [bookmark: _Hlk235712987]PRECICE Nail (NuVasive), FITBONE (Orthofix), Phenix M2 (Phenix Medical). [bookmark: _Toc236388458]DESCRIPTION OF DEVICE The device subject to this request is an active implantable intramedullary nail (specifically the Fitbone system) designed for limb lengthening and bone transport. Technically, it is an electromechanical motorized system surgically inserted into the medullary canal of long bones, such as the femur or tibia The nail contains an internal electric motor powered by a subcutaneous energy receiver connected via cable. Activation is performed externally by a transmitter that transfers energy to the motor, enabling controlled bone distraction. This system is specifically indicated for bone transport, a specialized surgical procedure used to reconstruct large segmental bone defects resulting from trauma, infection (osteomyelitis), tumor resection, or congenital conditions, utilizing the biological principle of distraction osteogenesis to naturally form new bone. [image: Immagine che contiene strumento Descrizione generata automaticamente] Other systems, such as Precice and Phenix M2 incorporate internal magnets that are rotated or adjusted non-invasively via an External Remote Controller. [bookmark: _Toc236388459]OUTCOME PARTIALLY ACCEPTED Since the FITBONE device covered by the request fall within the definition of active implantable, an update to category J ACTIVE-IMPLANTABLE DEVICES is proposed, with the creation of a new code J0801 ACTIVE INTRAMEDULLARY NAILS FOR LIMB LENGTHENING AND BONE TRANSPORT in the new section J08 ACTIVE IMPLANTABLE SKELETAL AND ORTHOPAEDIC DEVICES. To accommodate software and hardware accessories, consumables, and any medical device software, the following recurring levels have been created: J0880 ACTIVE IMPLANTABLE SKELETAL AND ORTHOPAEDIC DEVICES – HARDWARE ACCESSORIES J0882 ACTIVE IMPLANTABLE SKELETAL AND ORTHOPAEDIC DEVICES - SOFTWARE ACCESSORIES J0885 ACTIVE IMPLANTABLE SKELETAL AND ORTHOPAEDIC DEVICES - CONSUMABLES J0892 ACTIVE IMPLANTABLE SKELETAL AND ORTHOPAEDIC DEVICES - MEDICAL DEVICE SOFTWARE Rationale: Since request device is an electrically-powered fixation nail technically distinguished from passive fixation nails (Category P) as they convert transmitted energy into mechanical work to actively perform limb lengthening and bone transport, an update in J ACTIVE-IMPLANTABLE DEVICES is proposed. The proposal introduces section J08 and code J0801 to classify active implantable systems for bone distraction (e.g., motor-driven intramedullary nails). The creation of recurring levels J0880, J0882, J0885, and J0892 ensures structural harmonization with the EMDN Category J architecture and allows for the classification of essential external components—such as External Remote Controllers (ERC) and programming units—as well as materials and potential Medical Device Software (SaMD) for remote distraction monitoring. PROPOSAL CODE LEVEL TERMINAL LEVEL (YES/NO) TERM DESCRIZIONE J 1 YES ACTIVE-IMPLANTABLE DEVICES DISPOSITIVI IMPIANTABILI ATTIVI J01 2 NO CARDIAC FUNCTIONALITY IMPLANTABLE DEVICES DISPOSITIVI IMPIANTABILI PER FUNZIONALITÀ CARDIACA J02 2 NO IMPLANTABLE NEUROSTIMULATORS NEUROSTIMOLATORI IMPIANTABILI J03 2 NO AUDITORY ACTIVE-IMPLANTABLE DEVICES IMPIANTI AURICOLARI ATTIVI J04 2 NO IMPLANTABLE PUMPS POMPE IMPIANTABILI J05 2 NO BRACHYTHERAPY IMPLANTABLE DEVICES DISPOSITIVI IMPIANTABILI PER BRACHITERAPIA J06 2 NO ACTIVE IMPLANTABLE GLUCOSE MONITORING SYSTEMS SISTEMI IMPIANTABILI ATTIVI PER MONITORAGGIO DEL GLUCOSIO J07 2 NO OPHTHALMOLOGICAL USE ACTIVE IMPLANTABLE DEVICES DISPOSITIVI IMPIANTABILI ATTIVI PER IMPIEGO OFTALMOLOGICO J08 2 NO ACTIVE IMPLANTABLE SKELETAL AND ORTHOPAEDIC DEVICES DISPOSITIVI IMPIANTABILI ATTIVI PER APPARATO SCHELETRICO E ORTOPEDIA J0801 3 YES ACTIVE INTRAMEDULLARY NAILS FOR LIMB LENGTHENING AND BONE TRANSPORT CHIODI ENDOMIDOLLARI ATTIVI PER ALLUNGAMENTO DEGLI ARTI E TRASPORTO OSSEO J0880 3 YES ACTIVE IMPLANTABLE SKELETAL AND ORTHOPAEDIC DEVICES - HARDWARE ACCESSORIES DISPOSITIVI IMPIANTABILI ATTIVI PER APPARATO SCHELETRICO E ORTOPEDIA - ACCESSORI HARDWARE J0882 3 YES ACTIVE IMPLANTABLE SKELETAL AND ORTHOPAEDIC DEVICES - SOFTWARE ACCESSORIES DISPOSITIVI IMPIANTABILI ATTIVI PER APPARATO SCHELETRICO E ORTOPEDIA - ACCESSORI SOFTWARE J0885 3 YES ACTIVE IMPLANTABLE SKELETAL AND ORTHOPAEDIC DEVICES - CONSUMABLES DISPOSITIVI IMPIANTABILI ATTIVI PER APPARATO SCHELETRICO E ORTOPEDIA - MATERIALI SPECIFICI J0892 3 YES ACTIVE IMPLANTABLE SKELETAL AND ORTHOPAEDIC DEVICES - MEDICAL DEVICE SOFTWARE DISPOSITIVI IMPIANTABILI ATTIVI PER APPARATO SCHELETRICO E ORTOPEDIA - DISPOSITIVI MEDICI SOFTWARE J0899 3 YES ACTIVE IMPLANTABLE SKELETAL AND ORTHOPAEDIC DEVICES - OTHER DISPOSITIVI IMPIANTABILI ATTIVI PER APPARATO SCHELETRICO E ORTOPEDIA - ALTRI J99 2 YES ACTIVE-IMPLANTABLE DEVICES - OTHER DISPOSITIVI IMPIANTABILI ATTIVI - ALTRI [bookmark: _Toc236388460]ID 1592, 1593, 1594 – SHOULDER PROSTHESES [bookmark: _Toc236388461]REQUESTS DETAILS ID EMDN \Category EMDN Code or Reference Type of update Proposal (Specify Code XXX – Term XXX) Supporting Information 1592 P P0901040102 INSERT P090104010203 EPIPHYSARY HUMERAL COMPONENTS FOR REVERSE PROSTHESES - STEMLESS This category is not covered by existing epiphysary terms, leading to the use of the -99 'Other' code. Description: A stemless epiphysary humeral component for reverse prostheses is a Class III single-use implant that provides fixation in the humeral metaphysis only. It allows for the attachment of a humeral cup implant which interfaces with a glenosphere implant. Proposed Intended Use: Total reverse shoulder arthroplasty Proposed Indications for Use: Rotator cuff deficiency and a severely painful and/or arthritic joint due to osteoarthritis, post-traumatic arthritis or rotator cuff arthropathy. GMDN: 58950 Humeral Metaphyseal Anchor 1593 P P0901040101 INSERT P090104010103 EPIPHYSARY HUMERAL COMPONENTS FOR ANATOMICAL PROSTHESES – STEMLESS This category is not covered by existing epiphysary terms, leading to the use of the -99 'Other' code. Description: A stemless epiphysary humeral component for anatomical prostheses is a Class III single-use implant that provides fixation in the humeral metaphysis only. It allows for the attachment of a humeral head implant component. A copy of a representative Instructions for Use (IFU) is included. IFU-0902-60-060 Intended Use: Total anatomic shoulder arthroplasty Indications for Use: A severely painful and/or arthritic joint due to osteoarthritis. GMDN: 58950 Humeral Metaphyseal Anchor 1594 P P0901040101 INSERT P090104010104 EPIPHYSARY HUMERAL There is an EMDN for Inserts in the 'REVERSE' levels, however an EMDN for Inserts is required for 'ANATOMICAL' to avoid the use of the - 99 'OTHER' code. Description: An epiphysary insert component for anatomical prostheses is a Class III single-use implant that connects the humeral stem to the humeral head component. A copy of a representative Instructions for Use (IFU) is included. IFU 0902-60-178 Intended Use: Total anatomic shoulder arthroplasty Indications for Use: A severely painful and/or arthritic joint due to osteoarthritis; Humeral head fractures; Failed previous shoulder arthroplasty GMDN 60512 Shoulder Humeral Body Prosthesis Additional Information received attached or sent upon request · Request attachments: IFUs; · Additional info by email: addendum in pptx format; [bookmark: _Toc236388462]DESCRIPTION OF DEVICE Stemless metaphyseal humeral anchors are components utilized in shoulder implants to provide fixation within the humeral metaphysis without the use of a diaphyseal stem. Confined to the proximal humerus, these components are designed to preserve bone and can be utilized in both anatomical and reverse shoulder prostheses. [bookmark: _Toc236388463]OUTCOME PARTIALLY ACCEPTED · ID 1592, 1593: The analysis showed that stemless components are, in fact, not represented in the current Nomenclature. As these anchors do not reach the diaphyseal portion of the humerus, they cannot be considered diaphyseal components. The analysis also highlighted that these anchors can be used with both anatomical and reverse prosthetic systems. Therefore, the proposal is to INSERT a new level, P09010404 for SHOULDER PROSTHESES STEMLESS METAPHYSEAL HUMERAL ANCHOR. · ID 1594: No reference to "epiphyseal inserts for anatomical prostheses" was found during the analysis. Instead, the analysis revealed evidence of two components currently not represented in the nomenclature: collars and proximal humeral bodies. Regarding collars, we do not possess sufficient evidence or technical documentation to structure a proposal. Conversely, for proximal humeral bodies, we propose to INSERT a new level: P0901040103 for EPIPHYSEAL HUMERAL COMPONENTS - PROXIMAL BODIES. This level is proposed at a higher hierarchical position because these components are used in both anatomical and reverse procedures. · ADDITIONAL EDIT: We took the opportunity to update the translation of the anatomical terms to the more accurate forms: “epiphyseal”, “metaphyseal”, and “diaphyseal”. PROPOSAL CODE TERMINAL LEVEL TERM DESCRIZIONE P0901 NO SHOULDER PROSTHESES PROTESI DI SPALLA P090103 NO GLENOID COMPONENTS COMPONENTI GLENOIDEE P09010301 YES METAL BACK AND METAGLENE GLENOID BASEPLATES BASI GLENOIDALI (METAL BACK E METAGLENE) PER PROTESI DI SPALLA P09010302 YES ANATOMICAL SHOULDER PROSTHESIS INSERTS INSERTI PER PROTESI ANATOMICA DI SPALLA P09010303 YES GLENOSPHERES GLENOSFERA P09010304 YES MONOBLOCK GLENOIDS GLENOIDI MONOBLOCCO P09010399 YES GLENOID COMPONENTS - OTHER COMPONENTI GLENOIDEE - ALTRE P090104 NO SHOULDER PROSTHESES HUMERAL COMPONENTS COMPONENTI OMERALI PER PROTESI DI SPALLA P09010401 NO EPIPHYSEAL HUMERAL COMPONENTS COMPONENTI OMERALI EPIFISARIE P0901040101 NO EPIPHYSEAL HUMERAL COMPONENTS FOR ANATOMICAL PROSTHESES COMPONENTI OMERALI EPIFISARIE PER PROTESI ANATOMICA P090104010101 YES EPIPHYSEAL HUMERAL COMPONENTS FOR ANATOMICAL PROSTHESES - HUMERAL HEADS COMPONENTI OMERALI EPIFISARIE PER PROTESI ANATOMICA TESTE OMERALI P090104010102 YES EPIPHYSEAL HUMERAL COMPONENTS FOR RESURFACING ANATOMICAL PROSTHESES COMPONENTI OMERALI EPIFISARIE PER PROTESI ANATOMICA DI RIVESTIMENTO P0901040102 NO EPIPHYSEAL HUMERAL COMPONENTS FOR REVERSE PROSTHESES COMPONENTI OMERALI EPIFISARIE PER PROTESI INVERSA P090104010201 YES EPIPHYSEAL HUMERAL COMPONENTS FOR REVERSE PROSTHESES - INSERTS COMPONENTI OMERALI EPIFISARIE PER PROTESI INVERSA INSERTI P090104010202 YES EPIPHYSEAL HUMERAL COMPONENTS FOR REVERSE PROSTHESES - HUMERAL CUPS COMPONENTI OMERALI EPIFISARIE PER PROTESI INVERSA COPPE OMERALI P0901040103 YES EPIPHYSEAL HUMERAL COMPONENTS - PROXIMAL BODIES COMPONENTI OMERALI EPIFISARIE – CORPI PROSSIMALI P0901040199 YES EPIPHYSEAL HUMERAL COMPONENTS - OTHER COMPONENTI OMERALI EPIFISARIE - ALTRE P09010402 NO DIAPHYSEAL HUMERAL COMPONENTS COMPONENTI OMERALI DIAFISARIE P0901040201 YES SHOULDER PROSTHESES NON MODULAR STEMS STELI PER PROTESI DI SPALLA NON MODULARI P0901040202 YES SHOULDER PROSTHESES MODULAR STEMS STELI PER PROTESI DI SPALLA MODULARI P0901040203 NO MONOBLOCK DIAPHYSEAL HUMERAL COMPONENTS (STEM + EPIPHYSEAL COMPONENT) COMPONENTI OMERALI DIAFISARIE MONOBLOCCO (STELO + COMPONENTE EPIFISARIA) P090104020301 YES MONOBLOCK DIAPHYSEAL HUMERAL COMPONENTS FOR ANATOMICAL PROSTHESIS (STEM + HEAD) COMPONENTI OMERALI DIAFISARIE MONOBLOCCO PER PROTESI ANATOMICA (STELO + TESTA) P090104020302 YES MONOBLOCK DIAPHYSEAL HUMERAL COMPONENTS FOR REVERSE PROSTHESIS (STEM + CUP) COMPONENTI OMERALI DIAFISARIE MONOBLOCCO PER PROTESI INVERSA (STELO + COPPA) P0901040204 YES SHOULDER PROSTHESES REVISION STEMS STELI DA REVISIONE PER PROTESI DI SPALLA P0901040205 YES SHOULDER PROSTHESES LARGE RESECTIONS STEMS STELI PER GRANDI RESEZIONI PER PROTESI DI SPALLA P0901040299 YES DIAPHYSEAL HUMERAL COMPONENTS - OTHER COMPONENTI OMERALI DIAFISARIE - ALTRE P09010403 YES SHOULDER PROSTHESES SPACERS SPAZIATORI PER PROTESI DI SPALLA P09010404 YES SHOULDER PROSTHESES STEMLESS METAPHYSEAL HUMERAL ANCHOR ANCORAGGIO METAFISARIO OMERALE STEMLESS PER PROTESI DI SPALLA P09010499 YES HUMERAL COMPONENTS FOR SHOULDER PROSTHESES - OTHER COMPONENTI OMERALI PER PROTESI DI SPALLA - ALTRI P090180 NO SHOULDER PROSTHESES - ACCESSORIES PROTESI DI SPALLA - ACCESSORI P09018001 YES SHOULDER PROSTHESES FIXING SCREWS VITI DI FISSAGGIO PER PROTESI DI SPALLA P09018002 NO SHOULDER PROSTHESES ADAPTERS (INCLUDING CONES AND SLEEVES) ADATTATORI PER PROTESI DI SPALLA (COMPRESI CONI E MANICOTTI) P0901800201 YES GLENOID COMPONENTS ADAPTERS ADATTATORI PER COMPONENTI GLENOIDEI P0901800202 YES HUMERAL COMPONENTS ADAPTERS ADATTATORI PER COMPONENTI OMERALI P09018003 YES SHOULDER PROSTHESES ENDOMIDOLLAR CAPS TAPPI ENDOMIDOLLARI PER PROTESI DI SPALLA P09018099 YES SHOULDER PROSTHESES - ACCESSORIES - OTHER PROTESI DI SPALLA - ACCESSORI ALTRI P090199 YES SHOULDER PROSTHESES - OTHER PROTESI DI SPALLA - ALTRE [bookmark: _Toc236388464]ID 33_2026 – MOBILITY RESTRAINT SYSTEMS [bookmark: _Toc236388465]REQUESTS DETAILS ID EMDN \Category EMDN Code or Reference Type of update Proposal (specify Code XXX – Term XXX) Supporting information 33_2026 v V0804 NEW RESTRAINT SYSTEM The medical devices to restrain the motion mechanically/physically, warrants the patient safety, patient with cognitive problem, are not represented in the EMDN. All these types of system could be grouped under a same EMDN code (abdominal safety belt, ankle/wrist restraints, safety sleeping to prevent falls, etc...); In France, we had in the past, several serious incidents that have resulted in death. These types of devices can be installed on a medical bed or a wheelchair. They are different from splints; The restrain systems are different from splints and are separate medical devices, not accessories for beds or wheelchairs. The closest code could be V0804 (= PATIENT IMMOBILISERS in diagnostic or therapeutic procedures) but the restrain systems are not used during diagnostic or therapeutic procedures, they are used in the daily life. Additional Information received attached or sent upon request · No attachments and no additional information required [bookmark: _Toc236388466]DESCRIPTION OF DEVICE Devices for physical/mechanical patient restraint —such as abdominal safety belts, wrist/ankle restraints, and fall-prevention safety harnesses—designed to temporarily restrict movement for patient safety, particularly in individuals with cognitive impairments. Used in daily care settings on medical beds or wheelchairs, these devices are distinct from splints and bed/wheelchair accessories. [bookmark: _Toc236388467]OUTCOME PARTIALLY ACCEPTED The term associated with level V0804 with the current wording limits the range of devices to those related to diagnostic or therapeutic procedures. The proposal is to EDIT the term to avoid limitations for devices used not only during diagnostic or therapeutic procedures but also in daily life for medical purposes. PROPOSAL CODE TERM DESCRIZIONE V08 HEALTHCARE ACTIVITIES SUPPORTIVE EQUIPMENT AND AIDS ATTREZZATURE E AUSILI A SUPPORTO DELL'ATTIVITÀ SANITARIA … … … V0804 PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures for medical procedures in healthcare facilities or home care) IMMOBILIZZATORI PER PAZIENTI (durante procedure diagnostiche o terapeutiche per procedure mediche in strutture sanitarie o uso domiciliare) ... ... ... V0880 MEDICAL SUPPORT EQUIPMENT - ACCESSORIES ATTREZZATURE DI SUPPORTO ALL'ATTIVITÀ SANITARIA - ACCESSORI V0899 MEDICAL SUPPORT EQUIPMENT - OTHER ATTREZZATURE DI SUPPORTO ALL'ATTIVITÀ SANITARIA - ALTRE [bookmark: _Toc236388468]ID 1570, ID 1571, ID 1572 – SINGLE-USE NON-SPECIALIST SURGICAL INSTRUMENTS [bookmark: _Toc236388469]REQUESTS DETAILS ID EMDN \Category- EMDN Code or Reference Type of update Proposal (specify Code XXX – Term XXX) Supporting information 1570 V V08068099 INSERT V93- Medical Devices for General Surgery-Single Use The EMDN code for Single Use General Surgery Devices including Tweezers not available in this nomenclature so we need to add new level for this device group. Surgical tweezers are intended to hold and manipulate tissues or dressing materials such as cotton and gauze during surgical procedures, wound dressing changes, or packing of wounds. 1571 V INSERT V93- Medical Devices for General Surgery, Single Use The EMDN code for Single Use General Surgery Devices including Tweezers not available in this nomenclature so we need to add new level for this device group. General surgery retractors are used to separate or draw aside the margins of a wound, incision, or skin to provide access to underlying tissues or organs. They may also be used to hold tissues or organs out of the way during surgical procedures. 1572 V INSERT V93- Medical Devices for General Surgery, Single Use EMDN code for Single Use General Surgery Devices including Curettes not available in this nomenclature so we need to add new level for this device group. Surgical curettes with spoon shaped tips are used for scraping or debriding tissues during surgical procedures. Additional Information received attached or sent upon request · Labels [bookmark: _Toc236388470]DESCRIPTION OF DEVICE ID 1570: The devices subject to this request are single-use surgical tweezers (forceps) designed to hold and manipulate tissues or dressing materials, such as cotton and gauze, during surgical procedures, wound dressing changes, etc.. Technically, these include precision stainless steel tweezers intended for the precise manipulation of delicate structures. Their functional scope is multidisciplinary, ranging from handling small implants and suturing in dental surgery to meticulous graft preparation in orthopaedics and intricate reconstruction in plastic surgery. ID 1571: The devices subject to this request are single-use surgical retractors, which are hand-held, non-self-retaining instruments designed to separate or draw aside the margins of a wound, incision, or skin. They provide critical access to underlying tissues or organs and are used to hold them out of the way during procedures. These versatile tools, such as the skin retractor, are utilized across a broad spectrum of specialties, including ENT (for mucosal tissues), dental surgery, and orthopaedics (for managing soft tissues during joint replacements). ID 1572: The devices subject to this request are single-use surgical curettes, manual instruments with sharp, spoon-, cup-, or ring-shaped tips designed for scraping, debriding, or excising tissue from various anatomical sites. While some curettes are specialty-specific (e.g., uterine or ENT), this request specifically addresses versatile bone curettes. These are utilized for sinus procedures in ENT, bone grafting in oral surgery, debridement of bone surfaces in orthopaedics, and meticulous bone contouring in plastic and reconstructive surgery. [bookmark: _Toc236388471]OUTCOME PARTIALLY ACCEPTED The necessity for a dedicated level was confirmed by technical evaluation and market research. However, the proposal was partially accepted as the devices were reassigned to a different EMDN section than the one originally requested, ensuring a more appropriate and stable taxonomic placement. · [bookmark: _Toc236388472]ID 1570 (INSERT V93- MEDICAL DEVICES FOR GENERAL SURGERY-SINGLE USE (TWEEZERS)) [bookmark: _Hlk235524244]Rationale: The creation of a new level (V901201 NON-SPECIALIST SURGICAL TWEEZERS, SINGLE-USE ) for single-use tweezers not dedicated to a specific medical speciality, as a detail of V9012 NON-SPECIALIST SURGICAL INSTRUMENTS AND KITS, SINGLE-USE is necessary because the current EMDN does not have a specific code for single-use tweezers intended for general clinical use. Market analysis and manufacturer documentation demonstrate that these instruments are not limited to a single medical specialty. Instead, they are multidisciplinary tools essential for precision tissue manipulation in dental, orthopaedic, and plastic surgery, as well ward-based wound care. Placement under V9012 is systematically correct as it categorizes these devices based on their cross-cutting functional nature rather than a specific clinical field, thereby preventing the unnecessary dispersion of identical instruments across different specialized branches of the nomenclature. · [bookmark: _Toc236388473]ID 1571 (INSERT V93- MEDICAL DEVICES FOR GENERAL SURGERY, SINGLE USE (RETRACTORS)) [bookmark: _Hlk235526384]Rationale: The creation of a new level (V901202 NON-SPECIALIST SURGICAL RETRACTORS, SINGLE-USE) for single-use retractors not dedicated to a specific medical speciality as a detail of V9012 NON-SPECIALIST SURGICAL INSTRUMENTS AND KITS, SINGLE-USE, is necessary because the current EMDN does not have a specific code for general-purpose retractors. Technical evaluation of market-leading catalogues shows that retractors are indispensable across a broad spectrum of surgical disciplines, including ENT, dental surgery, and orthopaedics, and are widely used in surgical training environments. Since their application is multidisciplinary and cross-functional, they fit the definition of 'non-specialist' tools. Placement under V9012 follows the EMDN technical guidance to group general-use single-use instrumentation together, ensuring family integrity and improving data granularity. · [bookmark: _Toc236388474]ID 1572 (INSERT V93- MEDICAL DEVICES FOR GENERAL SURGERY, SINGLE USE (CURETTE)) Rationale: The creation of a new level (V901203 NON-SPECIALIST SURGICAL CURETTES, SINGLE-USE) for single-use curettes not dedicated to a specific medical speciality as a detail of V9012 NON-SPECIALIST SURGICAL INSTRUMENTS AND KITS, SINGLE-USE is necessary because the current EMDN does not have a specific code for general-purpose use. However, market evidence confirms the existence of versatile bone curettes that find extensive application across numerous medical disciplines, such as oral surgery, orthopaedics, and plastic surgery. Because these instruments are functional, multi-specialty devices and are also used in extra-operative settings like education and research, they are correctly defined as non-specialist tools. Placing them under V9012 allows for an accurate classification that reflects their multidisciplinary utility. · [bookmark: _Toc236388475]ADDITIONAL PROPOSAL COMING FROM EVALUATIONS Analysis of the market and medical device databases has highlighted the need to include additional codes for non-specialist surgical single-use forceps, spreaders, and scissors. PROPOSAL CODE LEVEL TERMINAL LEVEL (YES/NO) TERM DESCRIZIONE V90 2 NO VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES DISPOSITIVI VARI NON COMPRESI IN ALTRE CLASSI V9001 3 YES TONGUE DEPRESSORS, SINGLE-USE ABBASSALINGUA MONOUSO V9002 3 YES ENTEROCLYSIS DEVICES ENTEROCLISMI V9003 3 YES TOURNIQUETS LACCI EMOSTATICI V9004 3 YES SKIN MARKING DERMOGRAPHIC PENCILS AND PENS MATITE DERMOGRAFICHE E PENNE PER MARCATURA CUTANEA V9005 3 YES RUBBER SQUIRTS FOR IRRIGATION SCHIZZETTI IN GOMMA V9007 3 YES STERILE INSTRUMENT LUBRICANTS LUBRIFICANTI STERILI PER APPARECCHIATURE V9010 3 NO PARASITE ELIMINATION MECHANICAL DEVICES DISPOSITIVI AD AZIONE MECCANICA PER ELIMINAZIONE DI PARASSITI V901001 4 YES LICE ELIMINATION MECHANICAL DEVICES DISPOSITIVI AD AZIONE MECCANICA PER ELIMINAZIONE DI PIDOCCHI V901099 4 YES PARASITE ELIMINATION MECHANICAL DEVICES - OTHER DISPOSITIVI AD AZIONE MECCANICA PER ELIMINAZIONE DI PARASSITI - ALTRI V9011 3 YES MULTIFUNCTIONAL TRANSDUCERS TRASDUTTORI POLIFUNZIONALI V9012 3 NO NON-SPECIALIST SURGICAL INSTRUMENTS AND KITS, SINGLE-USE STRUMENTARIO CHIRURGICO NON SPECIALISTICO E KIT, MONOUSO V901201 4 YES NON-SPECIALIST SURGICAL TWEEZERS, SINGLE-USE PINZETTE PER CHIRURGIA NON SPECIALISTICA, MONOUSO [bookmark: _Hlk236309950]V901202 4 YES NON-SPECIALIST SURGICAL RETRACTORS, SINGLE-USE RETRATTORI PER CHIRURGIA NON SPECIALISTICA, MONOUSO [bookmark: _Hlk236310003]V901203 4 YES NON-SPECIALIST SURGICAL CURETTES, SINGLE-USE CURETTES PER CHIRURGIA NON SPECIALISTICA, MONOUSO V901204 4 YES NON-SPECIALIST SURGICAL FORCEPS, SINGLE-USE PINZE PER CHIRURGIA NON SPECIALISTICA, MONOUSO V901205 4 YES NON-SPECIALIST SURGICAL SPREADERS, SINGLE-USE DIVARICATORI PER CHIRURGIA NON SPECIALISTICA, MONOUSO V901206 4 YES NON-SPECIALIST SURGICAL SCISSORS, SINGLE-USE FORBICI PER CHIRURGIA NON SPECIALISTICA, MONOUSO V901207 4 YES NON-SPECIALIST SURGICAL KITS, SINGLE-USE KIT PER CHIRURGIA NON SPECIALISTICA, MONOUSO V901299 4 YES NON-SPECIALIST SURGICAL INSTRUMENTS AND KITS, SINGLE-USE - OTHER STRUMENTARIO CHIRURGICO NON SPECIALISTICO E KIT, MONOUSO - ALTRO V9015 3 YES ELECTRODES AND PROBES CUTANEOUS CONDUCTIVE SUBSTANCES SOSTANZE CONDUTTIVE CUTANEE PER ELETTRODI E SONDE V9016 3 NO SPECIALIST SURGICAL INSTRUMENTS AND KITS NOT INCLUDED IN OTHER CLASSES, SINGLE-USE STRUMENTARIO CHIRURGICO SPECIALISTICO E KIT, MONOUSO - NON COMPRESI IN ALTRE CLASSI V901601 4 YES PLASTIC SURGERY AND NON-AESTHETIC PURPOSES GENERIC USE INSTRUMENTS AND KITS, SINGLE-USE STRUMENTARIO PER CHIRURGIA PLASTICA E KIT AD USO GENERICO PER SCOPI NON ESTETICI, MONOUSO V901602 4 YES DERMOSURGERY INSTRUMENTS AND KITS, SINGLE-USE STRUMENTARIO PER DERMOCHIRURGIA E KIT, MONOUSO V901603 4 YES SUPERFICIAL TREATMENTS INSTRUMENTS AND KITS, SINGLE-USE STRUMENTARIO PER TRATTAMENTI SUPERFICIALI E KIT, MONOUSO V901699 4 YES SPECIALIST SURGICAL INSTRUMENTS AND KITS NOT INCLUDED IN OTHER CLASSES, SINGLE-USE - OTHER STRUMENTARIO CHIRURGICO SPECIALISTICO E KIT, MONOUSO - NON COMPRESI IN ALTRE CLASSI - ALTRI V9017 3 YES ORAL ADMINISTRATION PREPARATIONS NOT INCLUDED IN OTHER CLASSES PREPARATI PER SOMMINISTRAZIONE ORALE NON COMPRESI IN ALTRE CLASSI V9018 3 YES TRICHOTOMY MANUAL DEVICES DISPOSITIVI MANUALI PER TRICOTOMIA V9099 3 YES VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER DISPOSITIVI VARI NON COMPRESI IN ALTRE CLASSI - ALTRI [bookmark: _Toc617483316][bookmark: _Toc236388476]ID 30_2026 - INTRACARDIAC IMPLANT FOR ATRIAL SHUNT [bookmark: _Toc268167151][bookmark: _Toc236388477]REQUESTS DETAILS ID EMDN \Category EMDN Code or Reference Type of update Proposal (specify Code XXX – Term XXX) Supporting information 30_2026 P P0704 INSERT  P070405 - Intracardiac implant for ATRIAL SHUNT These devices are mainly used in cardiopediatry and are intented for intracardiac purpose (permanent atrioseptostomy). These devices are septal implants used in bailout procedures for some severe cardiac malformations. Specific EMDN codes already exist for carotid shunts (C019006) or intracoronary shunts (C03900202) , but none for implantable intracardiac shunts although they are different specific category of shunts. After searching in multiple EMDN codes specifically dedicated to Cardiovascular devices or in other EMDN codes related to broader cardiac or vascular devices, the only codes I could find were either anatomically incorrect (carotid, coronary) or not accurate enough (i.e. P0799) or already dedicated to another specific category of cardiac devices (J0190 = active implants only). This is the reason why I think that a specific EMDN code should be created for intracardiac devices indicated for atrial shunts. Additional Information received attached or sent upon request Category Details Medical Domain Cardiology, Interventional Cardiology Indication Permanent interatrial shunt creation for the management of heart failure with preserved ejection fraction (HFpEF). Description Implantable devices, designed to maintain a controlled left-to-right shunt within the atrial septum, reducing left atrial pressure and improving cardiac function. Materials Nitinol, medical-grade polymers, titanium. Commercial Names Corvia Atrial Shunt System, V-Wave Ventura Interatrial Shunt, Occlutech Atrial Flow Regulator (AFR). [bookmark: _Toc1089509123][bookmark: _Toc236388478]DESCRIPTION OF DEVICE · Corvia Atrial Shunt System: The Corvia Atrial Shunt System is a permanent implant designed to reduce left atrial pressure (LAP) by creating a controlled atrial septal shunt. It consists of a self-expanding nickel-titanium (nitinol) alloy structure featuring a double-disc design with an open 8mm central "barrel". Each disc is multi-legged, and the left atrial side includes radiopaque markers for visibility under imaging. The device is delivered through a percutaneous transvenous approach and is specifically indicated for adult patients with heart failure with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction who remain symptomatic despite standard medical therapy. · OCCLUTECH ATRIAL FLOW REGULATOR (AFR): The Occlutech AFR is a permanent, self-expanding nitinol wire mesh device intended to protect and preserve the opening created during a balloon atrial septostomy (BAS). Its architecture comprises two retention discs connected by a flexible body that houses a calibrated central fenestration (opening). The device is designed to conform fully to the atrial septum using a minimally invasive transcatheter technique. It is primarily used to manage hemodynamics in patients suffering from heart failure with either reduced (HFrEF) or preserved (HFpEF) ejection fraction. [bookmark: _Toc1785331218][bookmark: _Toc236388479]OUTCOME ACCEPTED Rationale: It’s reasonable to create a new level for this kind of devices/technology, indeed there are many devices already commercially available, and other devices are under research, in development or under clinical studies (APTURE Left Atrial to Coronary Sinus Shunt from EDWARDS LIFESCIENCE, V-Wave Interatrial Shunt from V-Wave), the intended use is extremely specific and it’s almost at the opposite of the cardiac occluders, and also there are many manufacturer (Corvia, Occlutech, V-Wave, Edwards Lifescience, Wuhan Vicktor). PROPOSAL CODE LEVEL TERMINAL LEVEL (YES/NO) TERM DESCRIZIONE P 1 NO IMPLANTABLE PROSTHETIC AND OSTEOSYNTHESIS DEVICES DISPOSITIVI PROTESICI IMPIANTABILI E MEZZI PER OSTEOSINTESI P01 2 NO PROSTHESES, FACIAL, ODONTOLOGICAL, AND CRANIAL PROTESI FACCIALI, ODONTOLOGICHE E CRANIALI ... ... ... ... P07 2 NO VASCULAR AND CARDIAC PROSTHESES PROTESI VASCOLARI E CARDIACHE P0701 3 NO VASCULAR PROSTHESES PROTESI VASCOLARI ... ... ... ... P0704 3 NO VASCULAR AND CARDIAC ENDOPROSTHESES ENDOPROTESI VASCOLARI E CARDIACHE P070401 4 NO VASCULAR ENDOPROSTHESES ENDOPROTESI VASCOLARI ... ... ... ... P070405 4 YES INTERATRIAL SHUNT DEVICES DISPOSITIVI PER SHUNT INTERATRIALE 2 image1.png image2.png image3.png image4.png image5.png image6.png image7.png image8.png image9.png image10.png image11.png image12.png image13.png image14.png image15.png