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Der Kern der ausgiebig diskutierten Apothekenreform, das ApoVWG, ist seit dem 2. Juli in Kraft. Einige der dort enthaltenen Regelungen sind damit unmittelbar in Kraft getreten, andere werden erst später wirksam. Demnach gelten bereits seit letztem Donnerstag: die erweiterte Nullretax-Regelung; die erweiterten Austauschmöglichkeiten bei nicht verfügbaren Rabattarzneimitteln (befristet auf zwei Jahre); die Abrechnung von Teilmengen von Fertigarzneimitteln; die Möglichkeit für Arztpraxen, Rezepte für Heimbewohner zu sammeln und unmittelbar an die heimversorgende Apotheke zu übermitteln (befristet bis 31.12.2028); die Möglichkeit, BtM-Fertigarzneimittel in Kommissionierautomaten zu lagern; der Ausschluss der persönlichen Haftung von Mitgliedern der Paritätischen Stelle; die Möglichkeit, die Leitung von Filial- und Zweigapotheken auf zwei Apothekerinnen/Apotheker aufzuteilen; die Aufhebung der Raumeinheit für Impfungen, pDL, Tests oder Blutabnahmen; die Erprobungsregelung zur Aufrechterhaltung des Apothekenbetriebs durch PTA (nach QMS-Anpassung, Information der Behörde und Antrag einer Genehmigung); die Möglichkeit des pharmazeutischen Personals, In-Vitro-Diagnostika für patientennahe Schnelltests auf Adeno-, Influenza- und RS-Viren sowie auf das Noro- und Rotavirus anzuwenden; die Möglichkeit von in-Vitro-Schnelltests auf HIV, Hepatitis-C-Virus, SARS-CoV-2 und Treponema pallidum; die Möglichkeit der Abgabe eines verschreibungspflichtigen Arzneimittels ohne Rezept als Anschlussversorgung mit Dauermedikation (§ 48a AMG); (die Möglichkeit, dem Patienten hierfür 5 Euro zusätzlich zu berechnen, ist noch Gegenstand einer beabsichtigten Rechtsverordnung, die noch vom Bundesrat zu bestätigen ist). Außerdem gelten mit dem Inkrafttreten des Gesetzes vorerst keine exklusiven Rabattverträge für Biosimilars. Die Regelungen aus dem ApoVWG, deren Inkrafttreten bzw. Wirksamwerden noch ausstehen, betreffen: die Möglichkeit der Abgabe eines verschreibungspflichtigen Arzneimittels ohne Rezept im Akutfall bei bestimmten, unkomplizierten Erkrankungen (§ 48b AMG); hierzu hat das Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) bis zum 02.07.2027 inhaltliche Empfehlungen auszusprechen, die dem Bundesgesundheitsministerium (BMG) dienen sollen, Vorgaben im Rahmen einer Rechtsverordnung zu erlassen; die neuen pharmazeutischen Dienstleistungen (pDL)*; hierfür hat zunächst die Bundesapothekerkammer innerhalb von zwei Monaten Standardanweisungen zu erstellen; bis zum 02.11.2026 haben der Deutsche Apothekerverband e.V. (DAV) und der GKV-Spitzenverband eine Vereinbarung zur Umsetzung einschl. Vergütung zu treffen; dazu kommt die Möglichkeit der Direktabrechnung mit den Kassen ab 01.01.2027; *ab 2027 kommen zu den bisherigen pDL folgende hinzu: Beratung mit Messungen zu Risikofaktoren Beratung zur Prävention tabakassoziierter Erkrankungen Pharmazeutisches Medikationsmanagement bei komplexer Dauermedikation Pharmazeutisches Medikationsmanagement bei neu verordneter Dauermedikation Erweiterte Einweisung in die korrekte Arzneimittelanwendung. die Möglichkeit, dass pharmazeutisches Personal Impfungen mit Nicht-Lebend-Impfstoffen durchführt; hierzu haben Bundesapothekerkammer (BAK) und Bundesärztekammer (BÄK) ein Mustercurriculum für die Schulung zu erstellen – und zwar innerhalb von zwei Monaten betr. Apothekerinnen und Apotheker sowie innerhalb von vier Monaten betr. PhiP, PTA und Pharmazieingenieure; bis zum 02.10.2026 haben der DAV und der GKV-Spitzenverband eine Vereinbarung über Vergütung und Abrechnung zu schließen; die venöse Blutabnahme; hierzu müssen BAK und BÄK bis zum 02.11.2026 ein Mustercurriculum erstellen; diese Tätigkeit ist durch die Apothekenleitung bei ihrer zuständigen Behörde anzuzeigen; die Hilfstaxe; hier betr. neue Vereinbarung zur Vergütung von Stoffen und Zubereitungen aus Stoffen; bis zum 01.01.2027 haben hierzu DAV und GKV-Spitzenverband im Benehmen mit dem PKV-Verband die Apothekeneinkaufspreise für in einer neuen Anlage 3 genannten Stoffe und für Zubereitungen aus diesen Stoffen zu vereinbaren; die neue Regelung zu den Notdienstpauschalen, die auch die neuen Teilnotdienste erfasst und zum 01.10.2026 in Kraft treten wird; in diesem Zusammenhang steht auch die Änderung im Fonds für die pDL (der bisherige pDL-Zuschlag in Höhe von 20 Cent entfällt ab 01.01.2027, dafür wird der Notdienstzuschlag auf 41 Cent erhöht). Alles Details zu den erwähnten Regelungen sowie weitere sind den Gesetzes- bzw. Verordnungstexten zu entnehmen. Weitere Änderungen werden sich noch aus der ausstehenden Rechtsverordnung (Verordnung zur Änderung der Apothekenbetriebsordnung und weiterer Verordnungen) ergeben. Diese betreffen u.a.: eine Empfehlung zur Anpassung der Honorare über eine jährliche Verhandlungslösung zwischen dem Verband der Apotheken und dem GKV-Spitzenverband (ab 2028); die Wiedereinführung von handelsüblichen Skonti zwischen Apotheken und dem pharmazeutischen Großhandel – nur bei vorfälliger Zahlung. den Zuschuss für Nacht- und Notdienste (siehe oben); die Möglichkeit einer zusätzlichen Vergütung im Falle der Abgabe von bestimmten verschreibungspflichtigen Arzneimitteln ohne Rezept (siehe auch oben); Maßnahmen zur Flexibilisierung des Personaleinsatzes sowie der Betriebsabläufe einschließlich der Öffnungszeiten; strengere Qualitätsvorgaben für den Arzneimittelversandhandel. Bereits seit 1. Juli in Kraft ist die Änderung der AMPreisV. Demnach beträgt seit diesem Datum das sog. Apothekenfixum EUR 9,00, das zum 01.01.2027 in einer zweiten Stufe auf EUR 9,50 erhöht wird. Dabei ist zu bedenken, dass nach dem jetzigen Stand des Gesetzgebungsverfahrens für ein BStabG der Apothekenabschlag ab 01.01.2027 von derzeit EUR 1,77 auf EUR 2,07 erhöht werden soll. Über die weiteren Entwicklungen und Umsetzungen wird Pharma Deutschland weiter berichten.

„Wieder einmal wird die pharmazeutische Industrie in erster Linie als Kostenfaktor innerhalb der GKV behandelt – und nicht als Schlüsselbranche, die Versorgung sichert, Innovation ermöglicht und industrielle Wertschöpfung nach Deutschland bringt. Dass sich der Herstellerabschlag mehr als verdoppelt und sich der Abschlag durch kumulativ wirkende weitere Maßnahmen noch weiter erhöht, müsste das Wirtschaftsministerium und das Bundeskanzleramt auf den Plan rufen. Mit dem Gesetz, das keine Befristung der Maßnahme vorsieht, riskiert die Bundesregierung nun sehenden Auges neue Standortschäden. Das zerstört das Vertrauen und Wirtschaftskraft“, sagt Jörg Wieczorek, Vorstandsvorsitzender von Pharma Deutschland. “Die Flinte ins Korn zu werfen, ist für unsere Branche keine Alternative“, betont Wieczorek. „Deshalb ist es notwendig, dass die Politik Pharma endlich nicht nur als Leitwirtschaft bezeichnet, sondern auch so behandelt." "Wenn die dem Gesetz folgende ressortübergreifende Pharmastrategie funktionieren soll, muss die Branche ernsthaft einbezogen werden und erhebliche strukturelle Verbesserungen erfolgen. Und das nicht als Randnotiz, sondern als Partner auf Augenhöhe.”" Jörg Wieczorek Vorstandsvorsitzender Pharma Deutschland kritisiert, dass die Regierungsfraktionen die Finanzprobleme der Gesetzlichen Krankenversicherung auch in der entscheidenden Phase des Verfahrens nicht umfassend und ganzheitlich angehen. Die Fixierung auf eine rechnerische Balance von Einnahmen und Ausgaben greift zu kurz, weil sie weder die strukturellen Ursachen der GKV-Finanzprobleme löst noch die wirtschaftspolitischen Folgen für eine der wichtigsten Industriebranchen des Landes ernsthaft angeht. Für Pharma Deutschland ist es enttäuschend und frustrierend, dass ausgerechnet in einer Phase wachsender Unsicherheit über Investitionen und Standortentscheidungen die Politik ein weiteres fatales Signal sendet. Statt das Gesundheitsfinanzierungssystem von versicherungsfremden Leistungen zu entlasten, werden die Rahmenbedingungen des Standorts Deutschland weiter verschlechtert.

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 GKV-Spargesetz zerstört Vertrauen und Wirtschaftskraft Wer Pharma nur als Kostenfaktor der GKV betrachtet, gefährdet Versorgung, Innovation und Wertschöpfung in Deutschland Berlin (6. Juli 2026) Mit den Änderungsanträgen der Regierungsfraktionen geht das Verfahren zum GKV-Spargesetz in seine entscheidende Phase. Die Abstimmung im Bundestag ist für den 10. Juli vorgesehen. Von der “Stärkung” der Pharmaindustrie wie es die Bundesregierung noch im November angekündigt hatte, kann keine Rede sein, im Gegenteil. Aus Sicht von Pharma Deutschland nimmt die Bundesregierung mit dem Gesetz statt angekündigter Nachbesserungen erhebliche zusätzliche Schäden für den Pharmastandort Deutschland in Kauf, ohne die Gesundheitsfinanzierung und -versorgung strukturell verbessert zu haben. „Wieder einmal wird die pharmazeutische Industrie in erster Linie als Kostenfaktor innerhalb der GKV behandelt – und nicht als Schlüsselbranche, die Versorgung sichert, Innovation ermöglicht und industrielle Wertschöpfung nach Deutschland bringt. Dass sich der Herstellerabschlag mehr als verdoppelt und sich der Abschlag durch kumulativ wirkende weitere Maßnahmen noch weiter erhöht, müsste das Wirtschaftsministerium und das Bundeskanzleramt auf den Plan rufen. Mit dem Gesetz, das keine Befristung der Maßnahme vorsieht, riskiert die Bundesregierung nun sehenden Auges neue Standortschäden. Das zerstört das Vertrauen und Wirtschaftskraft“, sagt Jörg Wieczorek, Vorstandsvorsitzender von Pharma Deutschland. “Die Flinte ins Korn zu werfen, ist für unsere Branche keine Alternative“, betont Wieczorek. „Deshalb ist es notwendig, dass die Politik Pharma endlich nicht nur als Leitwirtschaft bezeichnet, sondern auch so behandelt. Wenn die dem Gesetz folgende ressortübergreifende Pharmastrategie funktionieren soll, muss die Branche ernsthaft einbezogen werden und erhebliche strukturelle Verbesserungen erfolgen. Und das nicht als Randnotiz, sondern als Partner auf Augenhöhe.” mailto:hoenemann@pharmadeutschland.de 2 Pharma Deutschland kritisiert, dass die Regierungsfraktionen die Finanzprobleme der Gesetzlichen Krankenversicherung auch in der entscheidenden Phase des Verfahrens nicht umfassend und ganzheitlich angehen. Die Fixierung auf eine rechnerische Balance von Einnahmen und Ausgaben greift zu kurz, weil sie weder die strukturellen Ursachen der GKV-Finanzprobleme löst noch die wirtschaftspolitischen Folgen für eine der wichtigsten Industriebranchen des Landes ernsthaft angeht. Für Pharma Deutschland ist es enttäuschend und frustrierend, dass ausgerechnet in einer Phase wachsender Unsicherheit über Investitionen und Standortentscheidungen die Politik ein weiteres fatales Signal sendet. Statt das Gesundheitsfinanzierungssystem von versicherungsfremden Leistungen zu entlasten, werden die Rahmenbedingungen des Standorts Deutschland weiter verschlechtert. _______________ Der Pharma Deutschland e.V. ist der mitgliederstärkste Branchenverband der Pharmaindustrie in Deutschland. Er vertritt die Interessen von rund 400 Mitgliedsunternehmen, die in Deutschland ca. 80.000 Mitarbeiterinnen und Mitarbeiter beschäftigen. Die in Pharma Deutschland e.V. organisierten Unternehmen tragen maßgeblich dazu bei, die Arzneimittelversorgung in Deutschland zu sichern. So stellen sie fast 80 Prozent der in Apotheken verkauften rezeptfreien und fast zwei Drittel der rezeptpflichtigen Arzneimittel sowie einen Großteil der stofflichen und dentalen Medizinprodukte für die Patientinnen und Patienten bereit. Unter www.pharmadeutschland.de gibt es mehr Informationen zu Pharma Deutschland. http://www.pharmadeutschland.de/

Dem Protokoll der Sitzung sind folgende thematische Schwerpunkte zu entnehmen: Umsetzung der SoHO-Verordnung (EU) 2024/1938 Regulatorische Auslegung und Q&A-Dokumente Inspektionen und Notfallplanung Import von Plasma, Gameten und Embryos Entwicklung der EU-SoHO-Plattform EU4Health-Projekte zur Unterstützung der Umsetzung der SoHO-Verordnung Zusammenarbeit mit EDQM, ECDC und EMA Ein Schwerpunkt des Meetings lag auf der Verabschiedung neuer regulatorischer Hilfestellungen für die Mitgliedstaaten. So wurde ein umfangreicher Fragen- und Antwortenkatalog (Q&A) mit 39 neuen Auslegungen angenommen, darunter auch Leitlinien zur Überwachung von Aktivitäten im Zusammenhang mit Plasma Master Files. Zudem billigte das Board eine Kommunikationsstrategie, die den Übergang von bisher unter anderen Rechtsrahmen regulierten Tätigkeiten und Produkten in den Anwendungsbereich der SoHO-Verordnung unterstützen soll. Auch neue Inspektionsleitlinien wurden abgestimmt, um den zuständigen Behörden einen harmonisierten Rahmen für die Überwachung von SoHO-Einrichtungen bereitzustellen. Weitere Diskussionen befassten sich mit Notfallplänen für die Sicherstellung der Versorgung, den nationalen Vorbereitungen zur praktischen Umsetzung der Verordnung sowie Fragen zur Festlegung von Höchstgrenzen für Gametenspender. Zudem wurden Herausforderungen beim Import von Gameten und Embryonen aus Drittstaaten sowie beim Import von Plasma zur Fraktionierung erörtert. In mehreren Fällen sollen weitere Empfehlungen und Lösungsansätze durch die zuständigen Arbeitsgruppen erarbeitet werden. Die Arbeitsgruppen des SCB informierten über laufende Aktivitäten, insbesondere zur Registrierung und Zulassung von SoHO-Einrichtungen, zur Datenerhebung sowie zur Versorgungssicherheit. Darüber hinaus berichteten EDQM und ECDC über aktuelle Entwicklungen in ihren jeweiligen Arbeitsbereichen. Einen weiteren Schwerpunkt bildeten die Fortschritte bei der EU-SoHO-Plattform, die künftig die Verwaltung von Einrichtungen, Präparationen und Datenmeldungen unterstützen soll. Außerdem wurden mehrere EU4Health-Projekte vorgestellt, darunter IMPLEMENT SoHO und SHARE SoHO, die die praktische Umsetzung der neuen Verordnung begleiten und die Zusammenarbeit der Mitgliedstaaten fördern sollen. Der Termin für die nächste Sitzung wurde noch nicht bekannt gegeben.

Die Europäische Kommission beabsichtigt in ihrem Vorschlag für eine Verordnung zur Änderung der MDR und IVDR, die maximale Gültigkeitsdauer von Zertifikaten abzuschaffen. Anstelle einer erneuten Zertifizierung von Produkten sollen benannte Stellen regelmäßige Überprüfungen durchführen, die dem Risiko des Produkts angemessen seien. Dies erfordert eine zuverlässige Risikobewertung auf der Grundlage eines systematischen Verfahrens. Eine verstärkte Überwachungsintensität zu Beginn bildet die Grundlage für die Bewertung der Risiken, die mit einem bestimmten Medizinprodukt und seinem Hersteller verbunden sind, sowie für die Festlegung des künftigen Überwachungsniveaus auf der Grundlage dieser Bewertung. Aus diesem Grund hat das Team-NB ein Positionspapier mit einem ergänzenden Vorschlag veröffentlicht, in dem es seine Standpunkte und Änderungsvorschläge zur Anpassung des Überwachungssystems im Hinblick auf den Vorschlag der Kommission zur Aufhebung der maximalen Gültigkeitsdauer von Zertifikaten darlegt. Das Positionspapier enthält Einzelheiten zur Umsetzung der risikoadaptiven Überwachung von Medizinprodukten und Herstellern durch benannte Stellen. Zu den betroffenen Überwachungsmaßnahmen, deren Häufigkeit und Kriterien entsprechend dem geltenden Grad der risikoadaptiven Überwachung festzulegen sind, gehören insbesondere: Überwachungsaudits unangekündigte Audits Stichprobenentnahmen im Rahmen der Überwachung.

Study supporting the monitoring of the availability of medical devices on the EU market Survey results of the 20th NB survey (MDR/IVDR) with data status 28 February 2026 (small and medium dataset) 2 July 2026 1 • This document was produced in the frame of the SC 2021 P3 03 under the DG SANTE Framework contract (FWC SANTE/2021/OP/0002) for evaluation, impact assessment, monitoring and other related services in relation to health and food policies. • The information and views set out in this document are those of the author(s) and do not necessarily reflect the official opinion of the Commission/Executive Agency. Neither the Commission/Executive Agency nor any person acting on the Commission’s/Executive Agency’s behalf may be held responsible for the use which may be made of the information contained therein. • This presentation includes data and knowledge available at the time of the publication. The study-related dashboard contains the latest information und updates (e.g. further insights, retrospective corrections reported by stakeholders). Data discrepancies between this presentation and the regularly updated dashboard are therefore possible. 2 Disclaimer https://app.powerbi.com/view?r=eyJrIjoiMmRhNTZkOTAtNTM4YS00NmE5LWExYjYtZjIzYzI5YjUwMzRiIiwidCI6ImIyNGM4YjA2LTUyMmMtNDZmZS05MDgwLTcwOTI2ZjhkZGRiMSIsImMiOjh9 3 Acknowledgements The study team would like to sincerely thank the following institutions and people for the support in the 20th NB survey: • All 53 notified bodies designated under MDR and/or IVDR that participated in the survey (100% response rate); • The Directorate General for Health and Food Safety at the European Commission (DG SANTE) and the European Health and Digital Executive Agency (HaDEA); • Members of the MDCG TF on certification capacity monitoring. 1. About the study, survey and datasets 2. Survey results for medical devices 3. Survey results for in vitro diagnostic medical devices 4 Content MD IVD About Please cite as: Austrian National Public Health Institute, Areté, Civic Consulting (2026). PowerPoint presentation containing a study overview and survey results of the 20th NB survey for the ʻStudy supporting the monitoring of availability of medical devices on the EU marketʼ. Austrian National Public Health Institute (Gesundheit Österreich GmbH / GÖG). Commissioned by the European Commission within the EU4Health Programme (under specific contract No 2021 P3 03 with the European Health and Digital Executive Agency, implementing framework contract No SANTE/2021/OP/0002). 5 List of abbreviations (1) Abbreviation Meaning AIMDD Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices CE Conformité Européenne DG SANTE Directorate-General for Health and Food Safety EC European Commission EU European Union EURLs EU reference laboratories FTE Full Time Equivalent FWC Framework contract GÖG Gesundheit Österreich GmbH / Austrian National Public Health Institute HaDEA European Health and Digital Executive Agency IVDs In-vitro diagnostic medical device(s) IVDD Directive 98/79/EC of the European Parliament and of the Council on In Vitro Diagnostic Medical Devices IVDR Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 (In Vitro Diagnostic Medical Device Regulation) LD Large dataset 6 List of abbreviations (2) Abbreviation Meaning MD Medium dataset MDCG Medical Device Coordination Group MDs Medical device(s) MDD Council Directive 93/42/EEC of 14 June 1993 concerning medical devices MDR Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 (Medical Device Regulation) MFs Manufacturer(s) NBs Notified body / bodies QMS Quality Management System SC Special contract SD Small dataset SMCS Single Market Compliance Space SMEs Small and medium-sized enterprise(s) TF Task Force 7 1. About the study, survey and datasets • Study supporting the monitoring of availability of medical devices on the EU market • Preliminary notes • NB survey overview • Dashboard • Survey timeline • Response rate About • Commissioned by: The European Commission’s Directorate-General for Health and Food Safety (DG SANTE) via the European Health and Digital Executive Agency (HaDEA) • Aim: To support monitoring and analyzing the availability of medical devices on the EU market in the context of the implementation of medical devices and in vitro diagnostic medical devices Regulations from the perspectives of key stakeholders • Duration: 2 December 2022 – 1 June 2026 (42 months*) • Study team (contact: medical.devices@goeg.at): Austrian National Public Health Institute (Gesundheit Österreich GmbH / GÖG)  project lead Areté Civic Consulting Supported by experts from the medical devices sector 8 Study supporting the monitoring of availability of medical devices on the EU market About * Study amendment from 2 December 2025 – 1 June 2026 mailto:medical.devices@goeg.at • Data content: • The following slides show the results of the 20th NB survey conducted at the beginning of March 2026 with requested data from notified bodies designated under MDR and/or IVDR until 28 February 2026. • These survey results are also compared with previous survey data (see data sources). • Data sources: • Data collected between April 2023 and March 2026 by the study team • Data collected between February 2021 and October 2022 by the European Commission • Datasets: • This presentation contains the results of the small and medium datasets collected in March 2026. The small dataset is a small set of questions asked to notified bodies every two months. Note: From April to July 2023, it was asked monthly. The medium dataset is a set of questions asked to notified bodies every four months concerning the activities they have been performing since their designation. 9 Preliminary notes About Ⓢ 10 NB survey overview NB survey Survey period (survey launch – survey closure) Requested dataset* Requested data Response rate 1st NB survey 03/04/2023 - 05/05/2023 SD1 + MD1 from designation up to 31/03/2023 39 out of 39 NBs (100%) 2nd NB survey 12/05/2023 - 05/06/2023 SD2 from designation up to 30/04/2023 27 out of 39 NBs (~70%) 3rd NB survey 05/06/2023 - 19/06/2023 SD3 from designation up to 31/05/2023 22 out of 39 NBs (~56%) 4th NB survey 03/07/2023 - 28/07/2023 SD4 + MD2 from designation up to 30/06/2023 39 out of 39 NBs (100%) 5th NB survey 01/09/2023 - 06/10/2023 SD5 from designation up to 31/08/2023 40 out of 40 NBs (100%) 6th NB survey 03/11/2023 - 22/12/2023 SD6 + MD3 + LD1 from designation up to 31/10/2023 41 out of 41 NBs (100%) 7th NB survey 08/01/2024 - 05/02/2024 SD7 from designation up to 31/12/2023 45 out of 45 NBs (100%) 8th NB survey 04/03/2024 - 20/03/2024 SD8 + MD4 from designation up to 29/02/2024 45 out of 45 NBs (100%) 9th NB survey 02/05/2024 - 21/06/2024 SD9 from designation up to 30/04/2024 48 out of 48 NBs (100%) 10th NB survey 01/07/2024 - 06/08/2024 SD10 + MD5 from designation up to 30/06/2024 50 out of 50 NBs (100%) 11th NB survey 02/09/2024 - 17/10/2024 SD11 from designation up to 31/08/2024 50 out of 50 NBs (100%) 12th NB survey 06/11/2024 – 20/12/2024 SD12 + MD6 + LD2 + TE1* from designation up to 31/10/2024 51 out of 51 NBs (100%) 13th NB survey 21/01/2025 – 27/02/2025 SD13 + TE2** from designation up to 31/12/2024 51 out of 51 NBs (100%) 14th NB survey 03/03/2025 – 08/04/2025 SD14 + MD7 from designation up to 28/02/2025 51 out of 51 NBs (100%) 15th NB survey 05/05/2025 – 23/05/2025 SD15 from designation up to 30/04/2025 51 out of 51 NBs (100%) 16th NB survey 01/07/2025 – 02/09/2025 SD16 + MD8 + LD3 from designation up to 30/06/2025 51 out of 51 NBs (100%) 17th NB survey 01/10/2025 – 04/11/2025 SD17 from designation up to 30/08/2025 51 out of 51 NBs (100%) 18th NB survey 14/11/2025 – 15/12/2025 SD18 + MD9 from designation up to 31/10/2025 52 out of 52 NBs (100%) 19th NB survey 12/01/2026 – 10/02/2026 SD19 + LD4 from designation up to 31/12/2025 53 out of 53 NBs (100%) 20th NB survey 02/03/2026 – 31/03/2026 SD20 + MD10 from designation up to 28/02/2026 53 out of 53 NBs (100%)** About 20th NB survey results are presented in this PowerPoint presentation Note: SD = small dataset, MD = medium dataset, LD = large dataset * About the targeted evaluation: Evaluations conducted by the European Commission assess how well a specific policy intervention has performed (or is performing) and whether it is still relevant and justified. Evaluations are a key component of the lifecycle of any policy intervention. For the MDR and IVDR, the Commission has a legal obligation to conduct an evaluation of the Regulations by May 2027 (Article 121 MDR/Article 111 IVDR). The Commission has decided to launch a targeted evaluation of the Regulations in 2024. The 12th and 13th NB survey (conducted in the framework of the ‘Study supporting the monitoring of the availability of medical devices on the EU market’) were used to ask NBs questions that are relevant for the Targeted Evaluation. ** Due to a change in legal ownership of one notified body, data from previous surveys were used for the 20th NB survey • NB survey results are presented in the study-related dashboard • Available at: Study supporting the monitoring of availability of medical devices on the EU market - European Commission (europa.eu) • Instructions for use for the dashboard 11 Dashboard About https://health.ec.europa.eu/study-supporting-monitoring-availability-medical-devices-eu-market_en https://health.ec.europa.eu/study-supporting-monitoring-availability-medical-devices-eu-market_en https://health.ec.europa.eu/study-supporting-monitoring-availability-medical-devices-eu-market_en https://ppri.goeg.at/system/files/inline-files/Instructions_for_Use_HaDEA-2021-P3-03_17.11.2023_final.pdf https://ppri.goeg.at/system/files/inline-files/Instructions_for_Use_HaDEA-2021-P3-03_17.11.2023_final.pdf 12 2 March 2026 survey sent 16 March 2026 1st friendly reminder 18 March 2026 initial deadline 19 March 2026 2nd friendly reminder 23 March 2026 extended deadline from 24 March 2026 individual phone calls and emails 31 March 2026 survey closed April/May 2026 data validation 53 notified bodies designated under MDR and/or IVDR (data status: 2 March 2026) Final result 53 responses (100% response rate) About Note: Out of 53 notified bodies, 34 NBs are designated under the MDR only, 18 NBs are designated under both the MDR and IVDR, and 1 NB is designated under the IVDR only. Timeline for the 20th NB survey (conducted in March 2026 with requested data from designation up to 28/02/2026) Response rate for the 20th NB survey (conducted in March 2026 with requested data from designation up to 28/02/2026) 53 out of 53 notified bodies replies received (100% response rate) 13 MD Note: Out of 53 notified bodies, 34 NBs are designated under the MDR only, 18 NBs are designated under both the MDR and IVDR, and 1 NB is designated under the IVDR only. 100% response rate IVD 100% response rate About 19 19 0 2 4 6 8 10 12 14 16 18 20 Designated NBs under IVDR Replies received IVDR designated 52 52 0 10 20 30 40 50 60 Designated NBs under MDR Replies received MDR designated 14 2. Survey results for medical devices Note: • Thousands separators are represented as dots or blank space (not comma) in the graphs. • Datasets: The small dataset is a small set of questions asked to notified bodies every two months. Note: From April to July 2023, it was asked monthly. The medium dataset is a set of questions asked to notified bodies every four months concerning the activities they have been performing since their designation. The large dataset contains additional data asked to notified bodies once or twice a year. MD Ⓢ Ⓛ 15 Small dataset The small dataset is a small set of questions asked to notified bodies every two months. From April to July 2023, it was asked monthly. Ⓢ MD 989 20.698 31.902 0 5.000 10.000 15.000 20.000 25.000 30.000 35.000 Number of applications refused for MDR (from designation up to 28/02/2026) Number of written agreements signed (from designation up to 28/02/2026) Number of total certification applications lodged so far (from designation up to 28/02/2026) 16 MDR applications filed and refused, written agreements signed Notes: • Designated NBs for MD: 52 • Applications lodged: This number includes all applications lodged (syn. filed) so far according to MDR Annex VII section 4.3 (from the day when the designation became valid, i.e. one day after publication in the Single Market Compliance Space to the date of the survey up to 28/02/2026), i.e.: applications with issued certificates, applications without decisions on the outcome of the conformity assessment activities, applications that were eventually refused or withdrawn by the manufacturer (including transferred applications), applications lodged for changes of existing MDR certificates. Pre-application activities are not included. • Written agreements signed: This refers to the number of written agreements (contracts) between a NB and a manufacturer signed by both parties. MD Ⓢ https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies 17 MDR number of QMS / product certificates issued Note QMS Certificates: This relates to Annex IX Chapter I or Annex XI Part A according to MDR. Note PRODUCT Certificates: This relates to Annex IX Chapter II, Annex X or Annex XI Part B according to MDR. MD Ⓢ 12.036 6.373 0 2.000 4.000 6.000 8.000 10.000 12.000 14.000 Total number of QMS certificates issued for MDR (from designation up to 28/02/2026) Total number of QMS certificates issued for MDR (from designation up to 28/02/2026) - thereof first time only Number of QMS certificates issued (total and first time only) 6.203 3.291 0 1.000 2.000 3.000 4.000 5.000 6.000 7.000 Total number of product certificates issued for MDR (from designation up to 28/02/2026) Total number of product certificates issued for MDR (from designation up to 28/02/2026) - thereof first time only Number of product certificates issued (total and first time only) 7.970 12.125 8.343 13.883 8.564 14.275 9.422 15.530 10.132 16.664 11.053 17.941 11.708 19.368 12.324 20.704 13.646 23.553 15.363 26.497 16.395 27.315 17.729 28.512 18.173 27.830 18.476 28.594 19.050 29.410 19.455 29.439 21.003 30.871 21.426 31.864 21.791 31.101 20.698 31.902 0 5.000 10.000 15.000 20.000 25.000 30.000 35.000 Number of written agreements signed Number of total certification applications lodged incl. no. of applications with issued certificates S#20: from designation up to 28/02/2026 S#19: from designation up to 31/12/2025 S#18: from designation up to 31/10/2025 S#17: from designation up to 30/08/2025 S#16: from designation up to 30/06/2025 S#15: from designation up to 30/04/2025 S#14: from designation up to 28/02/2025 S#13: from designation up to 31/12/2024 S#12: from designation up to 31/10/2024 S#11: from designation up to 31/08/2024 S#10: from designation up to 30/06/2024 S#9: from designation up to 30/04/2024 S#8: from designation up to 29/02/2024 S#7: from designation up to 31/12/2023 S#6: from designation up to 31/10/2023 S#5: from designation up to 30/08/2023 S#4: from designation up to 30/06/2023 S#3: from designation up to 31/05/2023 S#2: from designation up to 30/04/2023 18 MD Survey comparison – March 2023 to February 2026 Ⓢ Notes: • S = Survey; # = number • Survey #20: 52 designated NBs for MD • Surveys #2 and #3 did not reach 100% response rate (#2: ~70%; #3: 56%). In this case, for the NBs that did not respond, data from previous surveys were included in the total for each indicator. • * Change in methodology of counting applications and written agreements by one NB in survey #13, #19 and #20, resulting in a decrease of total numbers. * * * 19 MD Survey comparison – March 2023 to February 2026 Ⓢ Notes: • S = Survey; # = number • Survey #20: 52 designated NBs for MD • Surveys #2 and #3 did not reach 100% response rate (#2: ~70%; #3: 56%). In this case, for the NBs that did not respond, data from previous surveys were included in the total for each indicator. * Change in methodology of counting refused applications compared to previous surveys by NBs in surveys #13 and #18. 354 409 428 435 486 510 581 638 746 834 842 853 743 995 1.058 1.115 1.157 918 944 989 0 200 400 600 800 1.000 1.200 1.400 Number of applications refused for MDR S#20: from designation up to 28/02/2026 S#19: from designation up to 31/12/2025 S#18: from designation up to 31/10/2025 S#17: from designation up to 30/08/2025 S#16: from designation up to 30/06/2025 S#15: from designation up to 30/04/2025 S#14: from designation up to 28/02/2025 S#13: from designation up to 31/12/2024 S#12: from designation up to 31/10/2024 S#11: from designation up to 31/08/2024 S#10: from designation up to 30/06/2024 S#9: from designation up to 30/04/2024 S#8: from designation up to 29/02/2024 S#7: from designation up to 31/12/2023 S#6: from designation up to 31/10/2023 S#5: from designation up to 30/08/2023 S#4: from designation up to 30/06/2023 S#3: from designation up to 31/05/2023 S#2: from designation up to 30/04/2023 S#1: from designation up to 31/03/2023 * * 20 MD Survey comparison – March 2023 to February 2026 Ⓢ S = Survey; # = number Notes: • Survey #20: 52 designated NBs for MD; • Surveys #2 and #3 did not reach 100% response rate (#2: ~70%; #3: 56%). In this case, for the NBs that did not respond, data from previous surveys were included in the total for each indicator. • Increase from survey #1 to #3; in survey #4, the questionnaire was redesigned, and the question on “total number of certificates issued” (in addition to “first time only”) was included in the small dataset. The redesign of the questionnaire helped the NBs to better assess the number of first-time only certificates. Therefore, the numbers of the previous surveys might be an overestimation. • * Change in methodology of counting by a few NBs compared to previous surveys in survey #4, #6 and #19, resulting in a decrease of total numbers. 967 1.943 1.056 2.096 1.123 2.201 1.207 1.930 1.829 2.210 1.331 2.433 1.487 2.690 1.632 2.910 1.785 3.157 2.074 3.537 2.177 3.766 2.317 4.015 2.494 4.301 2.812 4.500 2.890 4.900 3.243 5.117 3.392 6.262 3.493 7.069 3.199 6.060 3.291 6.373 0 1.000 2.000 3.000 4.000 5.000 6.000 7.000 8.000 Number of product certificates (first time only) Number of QMS certificates (first time only) S#20: from designation up to 28/02/2026 S#19: from designation up to 31/12/2025 S#18: from designation up to 31/10/2025 S#17: from designation up to 30/08/2025 S#16: from designation up to 30/06/2025 S#15: from designation up to 30/04/2025 S#14: from designation up to 28/02/2025 S#13: from designation up to 31/12/2024 S#12: from designation up to 31/10/2024 S#11: from designation up to 31/08/2024 S#10: from designation up to 30/06/2024 S#9: from designation up to 30/04/2024 S#8: from designation up to 29/02/2024 S#7: from designation up to 31/12/2023 S#6: from designation up to 31/10/2023 S#5: from designation up to 30/08/2023 S#4: from designation up to 30/06/2023 S#3: from designation up to 31/05/2023 S#2: from designation up to 30/04/2023 * * * * 21 Medium dataset The medium dataset is a set of questions asked to notified bodies every four months concerning the activities they have been performing since their designation. MD 1.840 2.721 3.920 6.188 8.120 10.818 13.177 17.846 20.424 25.987 28.037 28.489 32.920 33.107 32.898 224 340 502 1.069 1.990 2.951 3.899 5.599 6.978 8.900 10.497 12.177 14.831 17.507 18010 0 5.000 10.000 15.000 20.000 25.000 30.000 35.000 40.000 02 /2 02 1 03 /2 02 1 04 /2 02 1 05 /2 02 1 06 /2 02 1 07 /2 02 1 08 /2 02 1 09 /2 02 1 10 /2 02 1 11 /2 02 1 12 /2 02 1 01 /2 02 2 02 /2 02 2 03 /2 02 2 04 /2 02 2 05 /2 02 2 06 /2 02 2 07 /2 02 2 08 /2 02 2 09 /2 02 2 10 /2 02 2 11 /2 02 2 12 /2 02 2 01 /2 02 3 02 /2 02 3 03 /2 02 3 04 /2 02 3 05 /2 02 3 06 /2 02 3 07 /2 02 3 08 /2 02 3 09 /2 02 3 10 /2 02 3 11 /2 02 3 12 /2 02 3 01 /2 02 4 02 /2 02 4 03 /2 02 4 04 /2 02 4 05 /2 02 4 06 /2 02 4 07 /2 02 4 08 /2 02 4 09 /2 02 4 10 /2 02 4 11 /2 02 4 12 /2 02 4 01 /2 02 5 02 /2 02 5 03 /2 02 5 04 /2 02 5 05 /2 02 5 06 /2 02 5 07 /2 02 5 08 /2 02 5 09 /2 02 5 10 /2 02 5 11 /2 02 5 12 /2 02 5 01 /2 02 6 02 /2 02 6 Applications Certificates Poly. (Applications) Poly. (Certificates) MDR applications filed and certificates issued (sum of Annexes) MD 22 February 2026 MDR Applications: Total number of applications filed by Annex : 32.898* MDR Certificates: Total number of certificates by Annex : 18.010 ∆ 2.359 ∆ 948 ∆ 2.698 ∆ 1.932 ∆ 2.268∆ 1.199 ∆ 881 ∆ 116 ∆ 162 ∆ 567 ∆ 921 ∆ 961 ∆ 4.669 ∆ 1.700 ∆ 2.578 ∆ 1.379 ∆ 5.563 ∆ 1.922 ∆ 503 +2,9% ∆ -209** -0,6%** ∆ 2.050 ∆ 1.597 ∆ 4.431 ∆ 2.654 ∆ 452 ∆ 1.680 ∆ 187 ∆ 2.676 Notes: Designated NBs for MDR: 52 * The data shown comes from the medium data set – except for 3 NBs where the total number of applications filed was derived from the small data set Ⓢ, as they are not able to provide complete data per Annex. • ∆ (Delta) = Difference in MDR Applications / MDR Certificates from one survey to the next one • Applications filed: This number includes all applications filed (syn. lodged) so far according to MDR Annex VII section 4.3 (from the day when the designation became valid, i.e. one day after publication in the Single Market Compliance Space to the date of the survey up to 28/02/2026), i.e.: applications with issued certificates, applications without decisions on the outcome of the conformity assessment activities, applications that were eventually refused or withdrawn by the manufacturer (including transferred applications), applications lodged for changes of existing MDR certificates. Pre-application activities are not included. One application can correspond to more than one certificate. • Certificates issued: This number includes certificates issued so far (from designation up 28/02/2026) under the MDR. • The dotted line shows the polynomial trend line (grade 2). • ** Change in methodology of counting by a few NBs, resulting in a decrease of total number. ** https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies 1.096 677 0 67 0 1.659 947 1 114 0 2.292 1.485 0 143 0 3.635 2.240 6 305 2 4.687 2.927 3 500 3 6.212 3.859 5 739 3 8.045 4.094 5 1.026 7 9.429 4.578 12 725 24 10991 5106 13 898 14 14463 6187 21 1502 25 15594 7025 18 1676 14 16782 7463 18 1826 10 17502 8258 27 2105 12 18734 9485 27 2238 12 19117 8860 5 2302 3 0 5.000 10.000 15.000 20.000 25.000 Annex IX(I&III) Annex IX(II) Annex X Annex XI(A) Annex XI(B) Applications survey comparison Feb 2021 May 2021 Sept 2021 Apr 2022 Oct 2022 March 2023 June 2023 October 2023 February 2024 June 2024 October 2024 February 2025 June 2025 October 2025 February 2026 MDR applications by annex – survey comparison MD 23 Notes: • Designated NBs for MDR: 52; NBs that included Annex XVI products in the numbers provided: 31 • * The data shown comes from the medium data set – except for 3 NBs where the total number of applications filed was derived from the small data set Ⓢ, as they are not able to provide complete data per Annex. • ** Change in methodology of counting by a few NBs, leading to decreases. • Applications lodged by annex: This number includes all applications lodged (syn. filed) by annex according to MDR Annex VII section 4.3 (from the day when the designation became valid, i.e. one day after publication in the Single Market Compliance Space to the date of the survey up to 28/02/2026), i.e.: applications with issued certificates, applications without decisions on the outcome of the conformity assessment activities, applications that were eventually refused or withdrawn by the manufacturer (including transferred applications), applications lodged for changes of existing MDR certificates. Pre-application activities are not included. One application can correspond to more than one certificate. February 2026 MDR Applications: 32.898* ** ** ** https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies 163 19 0 42 0 263 28 0 49 0 379 59 0 64 0 724 253 0 92 0 1.295 555 1 134 5 1.773 990 2 181 5 2.409 1.208 2 273 7 3.463 1.819 3 301 13 4257 2314 3 390 14 5434 2959 6 491 10 6404 3490 7 586 10 7314 4128 6 707 10 8669 5184 6 949 23 10083 6299 6 1096 23 10565 6298 4 1129 14 0 2.000 4.000 6.000 8.000 10.000 12.000 Annex IX(I&III) Annex IX(II) Annex X Annex XI(A) Annex XI(B) Certificates survey comparison Feb 2021 May 2021 Sept 2021 Apr 2022 Oct 2022 March 2023 June 2023 October 2023 February 2024 June 2024 October 2024 February 2025 June 2025 October 2025 February 2026 MDR certificates by annex - survey comparison MD 24 Notes: • Designated NBs for MDR: 52; NBs that included Annex XVI products in the numbers provided: 31 • * The data shown comes from the medium data set • ** Change in methodology of counting by one NB leading to a decrease • Certificates issued by annex: This number includes certificates issued so far (from designation up to 28/02/2026) under the MDR by annex. February 2026 MDR Certificates: 18.010 ** ** ** 677 948 1.485 2.248 2.933 3.867 4.106 4.614 5.133 6.233 7057 7491 8297 9524 8868 19 28 59 253 561 997 1.217 1.835 2.331 2.975 3507 4144 5213 6328 6316 0 2.000 4.000 6.000 8.000 10.000 12.000 Feb 2021 May 2021 Sept 2021 Apr 2022 Oct 2022 Mar 2023 Jun 2023 Oct 2023 Feb 2024 Jun 2024 Oct 2024 Feb 2025 Jun 2025 Oct 2025 Feb 2026 Product Applications and Certificates PRODUCT Applications PRODUCT Certificates MDR applications and certificates by type (QMS vs Product) – survey comparison MD 25 Note QMS Applications and Certificates: This relates to Annex IX Chapter I or Annex XI Part A according to MDR. Note PRODUCT Applications and Certificates: This relates to Annex IX Chapter II, Annex X or Annex XI Part B according to MDR. * The data shown comes from the medium data set (applications and certificates by Annex: 3 NBs could not provide the complete application information by Annex; hence the total number of applications is higher - see number in the small data set). Total number of applications lodged for changes received for already MDR issued certificates: 9.724 Note: This number is included in the total number of applications. February 2026 MDR Applications: Total number of applications filed by Annex : 32.898* MDR Certificates: Total number of certificates by Annex : 18.010 ** ** ** Change in methodology of counting by one NB leading to a decrease. 1.163 1.773 2.435 3.940 5.187 6.951 9.071 10.154 11.889 15.965 17270 18608 19607 2097221419 205 312 443 816 1.429 1.954 2.682 3.764 4.647 5.925 6990 8021 9618 1117911694 0 5.000 10.000 15.000 20.000 25.000 Feb 2021 May 2021 Sept 2021 Apr 2022 Oct 2022 Mar 2023 Jun 2023 Oct 2023 Feb 2024 Jun 2024 Oct 2024 Feb 2025 Jun 2025 Oct 2025 Feb 2026 QMS Applications and Certificates QMS Applications QMS Certificates Specific additional procedures according to Annex IX (II) 26 MD Notes: * The data shown comes from the medium data set – except for 3 NBs where the total number of applications filed was derived from the small data set Ⓢ since they could not provide the data per Annex. February 2026 MDR Applications: Total number of applications filed by Annex : 32.898* MDR Certificates: Total number of certificates by Annex : 18.010 1175 12 162 387 8 0 0 200 400 600 800 1000 1200 1400 Devices incorporating a medicinal substance Devices manufactured utilising, or incorporating, tissues or cells of human or animal origin, or their derivatives, that are non-viable or rendered non-viable Devices that are composed of substances or of combinations of substances that are absorbed by or locally dispersed in the human body Specific additional procedures according to Annex IX (II) Applications filed requiring consultation procedure Thereof certificates issued 3.980 4.713 6.893 4.112 3.035 1.325 0 1.000 2.000 3.000 4.000 5.000 6.000 7.000 8.000 1-2 weeks 3-4 weeks 1 to 2 months 2 to 3 months 3 to 6 months >6 months Number of files Average timeframe between application lodged and written agreement signed: 27 Average timeframe to written agreement signed Note: Data of 52 notified bodies designated under MDR MD In the majority of the cases (65%), it takes less than 2 months from an application lodged to a written agreement signed. 156 131 109 85 30 13 0 20 40 60 80 100 120 140 160 180 Outside the scope of notified body's designation Application not complete Other Wrong qualification of product/classification of device Insufficient notified body resources Wrong conformity assessment procedure MDR applications - reasons for refusal 28 Notes: • ** Applications can have multiple reasons for refusal; the total number shown is derived from the small data set and differ from the figures in the medium data set indicated on the graph on this slide. • February 2026: some stated “other” reasons: “cancellation/withdrawal by the customer”, “requirements not met”; “client stopped communication”, “unresolved non-conformities, “outside the scope of insurance”, “language difference”, “voluntary renounce”. Total number of MDR applications: October 2022: 8120 March 2023: 11.418 June 2023: 13.177 October 2023: 17.846* February 2024: 20.424* June 2024: 26.185* October 2024: 28.069* February 2025: 28.489* June 2025: 32.974* October 2025: 33.292* February 2026: 32.898* February 2026 Main reasons - “Outside the scope of NB designation” (30%) - “Applications not complete” (25%) Number of application refusals**: October 2022: 232 March 2023: 269 June 2023: 328 October 2023: 367 February 2024: 454 June 2024: 576 October 2024: 562 February 2025: 650 June 2025: 727 October 2025: 918 February 2026: 989 MD * The total number comes from the medium data set – except for a few NBs where the total number of applications filed was derived from the small data set Ⓢ since they could not provide complete data per Annex. Completeness of submissions *Estimated percentage of submissions which were deemed satisfactory in terms of documentation provided (before undertaking the review of its content) without requesting for any additional information 29 N um be r o f n ot ifi ed b od ie s MD Number of notified bodies which report that > 50% of submissions are considered complete: 14 out of 52 NBs designated under MDR in February 2026 Incomplete submissions remain high* 15 21 18 13 17 23 22 22 14 15 15 7 12 12 16 16 15 15 13 17 22 23 5 2 4 5 7 9 9 13 18 12 12 5 3 4 5 3 2 4 2 1 2 2 0 10 20 30 40 50 60 Oct 22 Mar 23 June 23 Oct 23 Feb 24 June 24 Oct 24 Feb 25 June 25 Oct 25 Feb 26 Completeness of submissions expressed by notified bodies* (in number of NBs) (Annex VII, Section 4.3) – survey comparison Less than 25 % 25-50 % 51-75 % More than 75 % Time to reach a new certificate (QMS vs QMS+PRODUCT) 30 Notes: • This indicator shows the time to reach issuance of a new EC certificate (from written agreement signed to issuance) under MDR • QMS+PRODUCT: Data of 39 NBs designated under MDR; 13 NBs indicated that no QMS+PRODUCT certificate was issued yet • QMS: Data of 47 NBs designated under MDR; 5 NBs indicated that no QMS certificate was issued yet Pe rc en ta ge (% ) o f t ot al n um be r o f N B th at h av e is su ed c er tif ic at es MD February 2026 MDR Applications: 32.898* MDR Certificates: 18.010 * The total number comes from the medium data set – except for 3 NBs where the total number of applications filed was derived from the small data set Ⓢ, as they are not able to provide complete data per Annex MDR QMS certificates - 62% of NBs: 13-18 months to issue a new QMS certificate - 30% of NBs: 6-12 months MDR QMS+PRODUCT certificates: longer time - 51% of NBs: 13-18 months - 31% of NBs: 19-24 months 0% 8% 51% 31% 10% 2% 30% 62% 2% 4% 0% 10% 20% 30% 40% 50% 60% 70% <6 months 6-12 months 13-18 months 19-24 months >24 months Time to reach a new certificate (QMS vs QMS+PRODUCT) MDR_QMS MDR_QMS+PRODUCT Questions on Annex XVI products (products with no intended medical purpose that fall under the scope of the MDR) 31 Notes: 16th NB survey: 22 out of 50 NBs entered "0" for all questions relating to Annex XVI products 18th NB survey: 23 out of 50 NBs entered "0" for all questions relating to Annex XVI products. 20th NB survey: 23 out of 52 NBs entered "0" for all questions relating to Annex XVI products. MD 126 297 70 124 290 65 132 290 65 0 50 100 150 200 250 300 350 Estimation of transit of MDD certificates for Annex XVI products to the MDR without maintaining the medical purpose for the covered devices Received requests to sign a written agreement for a conformity assessment procedure of an Annex XVI product, in accordance with the condition established in Article 2(2) of Regulation (EU) 2022/2346, from 01/01/2023 Received requests to sign a written agreement for a conformity assessment procedure of an Annex XVI product, in accordance with the condition established in Article 2(1) of Regulation (EU) 2022/2346, from 01/01/2023 16th NB Survey (data from designation up to 30/06/2025) 18th NB Survey (data from designation up to 31/10/2025) 20th NB Survey (data from designation up to 28/02/2026) 32 Certificates issued for products without an intended medical purpose* and for dual purpose devices** LIST OF GROUPS OF PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE REFERRED TO IN ARTICLE 1(2) MDR 1. Contact lenses or other items intended to be introduced into or onto the eye. 2. Products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy or fixation of body parts with the exception of tattooing products and piercings. 3. Substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing. 4. Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty. 5. High intensity electromagnetic radiation (e.g. infra-red, visible light and ultra-violet) emitting equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment. 6. Equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain. Notes: Data of 13 NBs; 38 out of 51 NBs entered "0“ for all groups MD * Products without an intended medical purpose that are listed in Annex XVI to the MDR are covered by that Regulation from 22 June 2023, which is the date of application of Annex XVI common specifications set out in Commission Implementing Regulation (EU) 2022/2346. ** Dual purpose devices: products having both a medical and a non-medical intended purpose Notes: Data of 13 NBs; 39 out of 52 NBs entered "0“ for all groups 4 31 22 31 34 4 9 10 0 0 0 10 20 30 40 Total number of certificates issued so far for products without an intended medical purpose Total number of certificates issued for dual purpose devices 18th NB Survey (data from designation up to 31/10/2025) Group 1 Group 2 Group 3 Group 4 Group 5 Group 6 4 32 24 42 65 5 13 19 0 0 0 10 20 30 40 50 Total number of certificates issued so far for products without an intended medical purpose Total number of certificates issued for dual purpose devices 20th NB Survey (data from designation up to 28/02/2026) Group 1 Group 2 Group 3 Group 4 Group 5 Group 6 33 Single-use devices and their reprocessing (Article 17 MDR) Data of 52 NBs designated under MDR One NB indicated issuance of certificates: • 8 certificates issued in accordance with Art. 17(2) • No certificates issued in accordance with Art. 17(5) MD 1 31 20 Yes, certificate issued Not applicable (not in the designation scope of the NB) No certificates issued yet (although in the designation scope of the NB) 34 Article 117 MDR opinions* - requests received and opinions issued * Article 117 MDR: Where, in accordance with the second subparagraph of Article 1(8) or the second subparagraph of Article 1(9) of Regulation (EU) 2017/745 of the European Parliament and of the Council, a product is governed by this Directive, the marketing authorisation dossier shall include, where available, the results of the assessment of the conformity of the device part with the relevant general safety and performance requirements set out in Annex I to that Regulation contained in the manufacturer's EU declaration of conformity or the relevant certificate issued by a notified body allowing the manufacturer to affix a CE marking to the medical device. If the dossier does not include the results of the conformity assessment referred to in the first subparagraph and where for the conformity assessment of the device, if used separately, the involvement of a notified body is required in accordance with Regulation (EU) 2017/745, the authority shall require the applicant to provide an opinion on the conformity of the device part with the relevant general safety and performance requirements set out in Annex I to that Regulation issued by a notified body designated in accordance with that Regulation for the type of device in question. MD Notes 18th NB survey: • Total number of requests for Article 117 MDR opinions for initial market authorization submissions received: data of 25 NBs • Total number of requests for Article 117 MDR opinions for changes received: data of 6 NBs Notes 20th NB survey: • Total number of requests for Article 117 MDR opinions for initial market authorization submissions received: data of 26 NBs • Total number of requests for Article 117 MDR opinions for changes received: data of 7 NBs 474 37 367 23 0 200 400 600 Opinions for initial market authorisation submissions Opinions for changes 18th NB Survey (data from designation up to 31/10/2025) Total number of applications for Article 117 MDR opinions received Total number of Article 117 MDR opinions issued 553 46 437 33 0 200 400 600 Opinions for initial market authorisation submissions Opinions for changes 20th NB Survey (data from designation up to 28/02/2026) Total number of applications for Article 117 MDR opinions received Total number of Article 117 MDR opinions issued 35 3. Survey results for in vitro diagnostic medical devices IVD Note: • Thousands separators are represented as dots or blank space (not comma) in the graphs. • Datasets: The small dataset is a small set of questions asked to notified bodies every two months. Note: From April to July 2023, it was asked monthly. The medium dataset is a set of questions asked to notified bodies every four months concerning the activities they have been performing since their designation. The large dataset contains additional data asked to notified bodies once a year. Ⓢ Ⓛ 36 IVDR applications filed and refused, written agreements signed IVD Notes: • Designated NBs for IVD: 19 • Applications lodged: This number includes all applications lodged (syn. filed) so far according to IVDR Annex VII section 4.3 (from the day when the designation became valid, i.e. one day after publication in the Single Market Compliance Space to the date of the survey up to 28/02/2026), i.e.: applications with issued certificates, applications without decisions on the outcome of the conformity assessment activities, applications that were eventually refused or withdrawn by the manufacturer (including transferred applications), applications lodged for changes of existing MDR certificates. Pre-application activities are not included. • Written agreements signed: This refers to the number of written agreements (contracts) between a NB and a manufacturer signed by both parties. Ⓢ 145 1.813 3.723 0 500 1.000 1.500 2.000 2.500 3.000 3.500 4.000 Number of applications refused for IVDR (from designation up to 28/02/2026) Number of written agreements signed (from designation up to 28/02/2026) Number of total certification applications lodged so far (from designation up to 28/02/2026) https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies 37 IVDR Number of QMS / product certificates issued Note QMS Certificates: This relates to Annex IX Chapter I or Annex XI according to IVDR. Note PRODUCT Certificates: This relates to Annex IX Chapter II or Annex X according to IVDR. IVD Ⓢ 1.302 1.007 0 200 400 600 800 1.000 1.200 1.400 Total number of product certificates issued for IVDR (from designation up to 28/02/2026) Total number of product certificates issued for IVDR (from designation up to 28/02/2026) - thereof first time only Number of product certificates issued (total and first time only) 1.040 565 0 200 400 600 800 1.000 1.200 Total number of QMS certificates issued for IVDR (from designation up to 28/02/2026) Total number of QMS certificates issued for IVDR (from designation up to 28/02/2026) - thereof first time only Number of QMS certificates issued (total and first time only) 38 Survey comparison – March 2023 to February 2026 S = Survey; # = number Notes: • Designated NBs for IVDs: S#1 to S#5: 10; S#6 to S#11: 12; S#12 to S#13: 13; S#14: 14; S#15: 16, S#16: 17, S#17: 18, S#18-#20: 19 • Surveys #2 and #3 did not reach 100% response rate (S#2: ~70%; S#3: 56%). In this case, for the NBs that did not respond, data from previous surveys were included in the total for each indicator. IVD Ⓢ 521 1.014 543 1.071 571 1.111 609 1.157 683 1.295 736 1.451 785 1.565 845 1.694 913 1.821 1.004 2.017 1.046 2.181 1.107 2.341 1.163 2.388 1.195 2.532 1.256 2.742 1.463 3.011 1.571 3.155 1.728 3.531 1.753 3.605 1.813 3.723 0 500 1.000 1.500 2.000 2.500 3.000 3.500 4.000 Number of written agreements signed Number of total certification applications lodged incl. no. of applications with issued certificates S#20: from designation up to 28/02/2026 S#19: from designation up to 31/12/2025 S#18: from designation up to 31/10/2025 S#17: from designation up to 30/08/2025 S#16: from designation up to 30/06/2025 S#15: from designation up to 30/04/2025 S#14: from designation up to 28/02/2025 S#13: from designation up to 31/12/2024 S#12: from designation up to 31/10/2024 S#11: from designation up to 31/08/2024 S#10: from designation up to 30/06/2024 S#9: from designation up to 30/04/2024 S#8: from designation up to 29/02/2024 S#7: from designation up to 31/12/2023 S#6: from designation up to 31/10/2023 S#5: from designation up to 30/08/2023 S#4: from designation up to 30/06/2023 S#3: from designation up to 31/05/2023 39 Survey comparison – March 2023 to February 2026 S = Survey; # = number Notes: • Designated NBs for IVDs: S#1 to S#5: 10; S#6 to S#11: 12; S#12 to S#13: 13; S#14: 14; S#15: 16, S#16:16, S#17: 18, S#18-#20: 19 (1 NB reporting 127 refused applications) • Surveys #2 and #3 did not reach 100% response rate (S#2: ~70%; S#3: 56%). In this case, for the NBs that did not respond, data from previous surveys were included in the total for each indicator. • * Change in methodology of counting refused applications compared to previous surveys by NBs in survey #12. IVD Ⓢ 30 32 35 40 41 44 45 47 55 64 75 68 72 84 97 104 106 111 113 145 0 20 40 60 80 100 120 140 160 Number of applications refused for IVDR S#20: from designation up to 28/02/2026 S#19: from designation up to 31/12/2025 S#18: from designation up to 31/10/2025 S#17: from designation up to 30/08/2025 S#16: from designation up to 30/06/2025 S#15: from designation up to 30/04/2025 S#14: from designation up to 28/02/2025 S#13: from designation up to 31/12/2024 S#12: from designation up to 31/10/2024 S#11: from designation up to 31/08/2024 S#10: from designation up to 30/06/2024 S#9: from designation up to 30/04/2024 S#8: from designation up to 29/02/2024 S#7: from designation up to 31/12/2023 S#6: from designation up to 31/10/2023 S#5: from designation up to 30/08/2023 S#4: from designation up to 30/06/2023 S#3: from designation up to 31/05/2023 * 40 IVD ⓈSurvey comparison – March 2023 to February 2026 S = Survey; # = number Notes: • Designated NBs for IVDs: S#1 to S#5: 10; S#6 to S#11: 12; S#12 to S#13: 13; S#14: 14; S#15: 16, S#16: 17, S#17: 18, S#18 & #19: 19 • Surveys #2 and #3 did not reach 100% response rate (S#2: ~70%; S#3: 56%). In this case, for the NBs that did not respond, data from previous surveys were included in the total for each indicator. • * One NB revised its methodology for counting QMS certificates in survey #19, resulting in a decrease of total numbers. 169 169 177 177 202 183 235 190 283 206 287 231 347 244 371 252 416 282 460 318 523 336 580 368 629 390 678 408 712 434 788 450 876 642 913 655 964 536* 1.007 565 0 200 400 600 800 1.000 1.200 Number of product certificates (first time only) Number of QMS certificates (first time only) S#20: from designation up to 28/02/2026 S#19: from designation up to 31/12/2025 S#18: from designation up to 31/10/2025 S#17: from designation up to 30/08/2025 S#16: from designation up to 30/06/2025 S#15: from designation up to 30/04/2025 S#14: from designation up to 28/02/2025 S#13: from designation up to 31/12/2024 S#12: from designation up to 31/10/2024 S#11: from designation up to 31/08/2024 S#10: from designation up to 30/06/2024 S#9: from designation up to 30/04/2024 S#8: from designation up to 29/02/2024 S#7: from designation up to 31/12/2023 S#6: from designation up to 31/10/2023 S#5: from designation up to 30/08/2023 S#4: from designation up to 30/06/2023 S#3: from designation up to 31/05/2023 41 Medium dataset The medium dataset is a set of questions asked to notified bodies every four months concerning the activities they have been performing since their designation. IVD 249 345 512 648 822 950 1.155 1.479 1634 1747 2200 2395 3083 3304 3418 7 11 31 125 268 331 500 639 798 940 1273 1490 1779 2192 2318 0 500 1000 1500 2000 2500 3000 3500 4000 02 /2 02 1 03 /2 02 1 04 /2 02 1 05 /2 02 1 06 /2 02 1 07 /2 02 1 08 /2 02 1 09 /2 02 1 10 /2 02 1 11 /2 02 1 12 /2 02 1 01 /2 02 2 02 /2 02 2 03 /2 02 2 04 /2 02 2 05 /2 02 2 06 /2 02 2 07 /2 02 2 08 /2 02 2 09 /2 02 2 10 /2 02 2 11 /2 02 2 12 /2 02 2 01 /2 02 3 02 /2 02 3 03 /2 02 3 04 /2 02 3 05 /2 02 3 06 /2 02 3 07 /2 02 3 08 /2 02 3 09 /2 02 3 10 /2 02 3 11 /2 02 3 12 /2 02 3 01 /2 02 4 02 /2 02 4 03 /2 02 4 04 /2 02 4 05 /2 02 4 06 /2 02 4 07 /2 02 4 08 /2 02 4 09 /2 02 4 10 /2 02 4 11 /2 02 4 12 /2 02 4 01 /2 02 5 02 /2 02 5 03 /2 02 5 04 /2 02 5 05 /2 02 5 06 /2 02 5 07 /2 02 5 08 /2 02 5 09 /2 02 5 10 /2 02 5 11 /2 02 5 12 /2 02 5 01 /2 02 6 02 /2 02 6 Applications Certificates Poly. (Applications) IVDR applications lodged and certificates issued 42 February 2026 IVDR Applications: 3.418 IVDR Certificates: 2.318 Notes: Designated NBs for IVDR in February: 19 • ∆ (Delta) = Difference in IVDR Applications / IVDR Certificates from one survey to the next one • Applications lodged: This number includes all applications lodged (syn. filed) so far according to IVDR Annex VII section 4.3 (from the day when the designation became valid, i.e. one day after publication in the Single Market Compliance Space to the date of the survey up to 28/02/2026), i.e.: applications with issued certificates, applications without decisions on the outcome of the conformity assessment activities, applications that were eventually refused or withdrawn by the manufacturer (including transferred applications), applications lodged for changes of existing IVDR certificates. Pre-application activities are not included. One application can correspond to more than one certificate. • Certificates issued: This number includes certificates issued so far (from designation up to 28/02/2026) under the IVDR. • The dotted line shows the polynomial trend line (grade 2). ∆ 96 ∆ 4 ∆ 167 ∆ 20 ∆ 136 ∆ 94 ∆ 174 ∆ 143 ∆ 128 ∆ 63 ∆ 205 ∆ 169 IVD ∆ 139 ∆ 324 ∆ 155 ∆ 159 ∆ 113 ∆ 333 ∆ 453 ∆ 142 ∆ 114 +4% ∆ 126 +6% ∆ 217 ∆ 195 ∆ 688 ∆ 289 ∆ 221 ∆ 413 https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies IVDR applications and certificates by annex 43 Notes: • Applications lodged by annex: This number includes all applications lodged (syn. filed) by annex according to IVDR Annex VII section 4.3 (from the day when the designation became valid, i.e. one day after publication in NANDO to the date of the survey up to 28/02/2026), i.e.: applications with issued certificates, applications without decisions on the outcome of the conformity assessment activities, applications that were eventually refused or withdrawn by the manufacturer (including transferred applications), applications lodged for changes of existing MDR certificates. Pre-application activities are not included. One application can correspond to more than one certificate. • Certificates issued by annex: This number includes certificates issued so far (from designation up to 28/02/2026) under the IVDR by annex. • Class D devices are included in the total number of applications/certificates. • * Change in methodology of counting compared to previous surveys by one NB. February 2026 IVDR Applications: 3.418 IVDR Certificates: 2.318 IVD 1428 1976 0 14 1008 1300 0 10 0 500 1000 1500 2000 2500 Annex IX(I&III) Annex IX(II) Annex X Annex XI Total IVDR applications/certificates by Annex Applications Certificates * * 6 1 0 09 2 0 020 11 0 059 66 0 0 154 114 0 0 159 164 0 8 255 237 0 8 321 315 0 3 384 410 0 4 489 446 0 5 594 673 0 6 692 791 0 7 848 922 0 9 1078 1105 0 9 1008 1300 0 10 0 200 400 600 800 1000 1200 1400 Annex IX(I&III) Annex IX(II) Annex X Annex XI Certificates survey comparison Feb 2021 May 2021 Sept 2021 Apr 2022 Oct 2022 March 2023 June 2023 Oct 2023 Feb 2024 June 2024 Oct 2024 Feb 2025 June 2025 Oct 2025 Feb 2026 86 163 0 0 127 216 0 2 205 307 0 0 296 352 0 0 357 465 0 0 395 534 0 21 486 646 0 23 715 759 0 5 767 860 0 7 819 921 0 7 1020 1169 0 11 1089 1295 0 11 1534 1537 0 12 1525 1765 0 14 1428 1976 0 14 0 500 1000 1500 2000 2500 Annex IX(I&III) Annex IX(II) Annex X Annex XI Applications survey comparison Feb 2021 May 2021 Sept 2021 Apr 2022 Oct 2022 March 2023 June 2023 Oct 2023 Feb 2024 June 2024 Oct 2024 Feb 2025 June 2025 Oct 2025 Feb 2026 IVDR applications and certificates by annex – surveys comparison 44 February 2026 IVDR Certificates: 2.318 February 2026 IVDR Applications: 3.418 Notes: • Applications lodged by annex: This number includes all applications lodged (syn. filed) by annex according to IVDR Annex VII section 4.3 (from the day when the designation became valid, i.e. one day after publication in the Single Market Compliance Space to the date of the survey up to 28/02/2026), i.e.: applications with issued certificates, applications without decisions on the outcome of the conformity assessment activities, applications that were eventually refused or withdrawn by the manufacturer (including transferred applications), applications lodged for changes of existing IVDR certificates. Pre-application activities are not included. One application can correspond to more than one certificate. • Certificates issued by annex: This number includes certificates issued so far (from designation up to 28/02/2026) under the IVDR by annex. • * Change in methodology of counting compared to previous surveys by one NB, resulting in a decrease of total numbers. IVD * * https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies Class D devices applications and certificates 45 Notes: • Applications lodged by annex: This number includes all applications lodged (syn. filed) by annex according to IVDR Annex VII section 4.3 (from the day when the designation became valid, i.e. one day after publication in the Single Market Compliance Space to the date of the survey up to 28/02/2026), i.e.: applications with issued certificates, applications without decisions on the outcome of the conformity assessment activities, applications that were eventually refused or withdrawn by the manufacturer (including transferred applications), applications lodged for changes of existing IVDR certificates. Pre-application activities are not included. One application can correspond to more than one certificate. • Certificates issued by annex: This number includes certificates issued so far (from designation up to 28/02/2026) under the IVDR by annex. February 2026: Total number of Class D devices Applications: 1.191 Total number of Class D devices Certificates: 722 IVD February 2026 IVDR Applications: 3.418 IVDR Certificates: 2.318 257 934 0 0 166 556 0 0 0 100 200 300 400 500 600 700 800 900 1000 Annex IX(I&III) Annex IX(II) Annex X Annex XI Class D devices applications/certificates by annex Applications Certificates https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies Class D IVDs applications and certificates development 46 Note: Applications lodged by annex: This number includes all applications lodged (syn. filed) by annex according to IVDR Annex VII section 4.3 (from the day when the designation became valid, i.e. one day after publication in NANDO to the date of the survey up to 28/02/2026), i.e.: applications with issued certificates, applications without decisions on the outcome of the conformity assessment activities, applications that were eventually refused or withdrawn by the manufacturer (including transferred applications), applications lodged for changes of existing MDR certificates. Pre- application activities are not included. One application can correspond to more than one certificate. IVD Note: Certificates issued by annex: This number includes certificates issued so far (from designation up to 28/02/2026) under the IVDR by annex. February 2026: Total number of Class D devices applications: 1.191 Total number of Class D devices certificates: 722 33 149 0 0 48 179 0 0 68 268 0 0 71 299 0 0 124 392 0 0 157 501 0 0 167 598 0 0 204 747 0 0 249 848 0 0 257 934 0 0 0 100 200 300 400 500 600 700 800 900 1000 Annex IX(I&III) Annex IX(II) Annex X Annex XI Class D devices applications by annex Class D devices applications by annex March 2023 Class D devices applications by annex June 2023 Class D devices applications by annex October 2023 Class D devices applications by annex February 2024 Class D devices applications by annex June 2024 Class D devices applications by annex October 2024 Class D devices applications by annex February 2025 Class D devices applications by annex June 2025 Class D devices applications by annex October 2025 Class D devices applications by annex February 2026 2 25 0 07 55 0 020 99 0 0 26 147 0 0 57 213 0 0 95 282 0 0 128 338 0 0 139 412 0 0 161 469 0 0 166 556 0 0 0 100 200 300 400 500 600 Annex IX(I&III) Annex IX(II) Annex X Annex XI Class D devices certificates by annex Class D devices certificates by annex March 2023 Class D devices certificates by annex June 2023 Class D devices certificates by annex October 2023 Class D devices certificates by annex February 2024 Class D devices certificates by annex June 2024 Class D devices certificates by annex October 2024 Class D devices certificates by annex February 2025 Class D devices certificates by annex June 2025 Class D devices certificates by annex October 2025 Class D devices certificates by annex February 2026 16 0 1 0 24 0 2 0 26 0 6 0 27 0 6 0 33 0 11 0 39 0 17 0 42 0 20 0 51 0 21 0 63 0 22 0 80 0 30 0 0 10 20 30 40 50 60 70 80 90 Applications lodged requiring consultation for CDx of which applications for Class D devices Certificates issued requiring consultation for CDx of which certificates for Class D devices Applications lodged and certificates issued requiring consultation for companion diagnostics S#1: from designation up to 31/03/2023 S#4: from designation up to 30/06/2023 S#6: from designation up to 31/10/2023 S#8: from designation up to 29/02/2024 S#10: from designation up to 30/06/2024 S#12: from designation up to 31/10/2024 S#14: from designation up to 28/02/2025 S#16: from designation up to 30/06/2025 S#18: from designation up to 31/10/2025 S#20: from designation up to 28/02/2026 47 Applications and certificates requiring consultation for companion diagnostics (CDx)* February 2026 Class D devices applications: 1.191 Class D devices certificates: 722 IVD * According to Article 2 (7) IVDR, a companion diagnostic means a device which is essential for the safe and effective use of a corresponding medicinal product to: (a) identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or (b) identify, before and/or during treatment, patients likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal product. 20th NB survey: data of 3 NBs Applications Certificates February 2026 IVDR Applications: 3.418 IVDR Certificates: 2.318 https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0746 Has a Class D application been lodged from 1 October 2024 in any of the following four categories of currently designated EURLs? 48 Collaboration with EU reference laboratories (EURLs) on Class D devices (1) Data of 19 NBs designated under IVDR Has a Class D certificate been issued in any of the following six categories of currently designated EURLs? IVD 9 3 5 2 10 16 14 17 0 5 10 15 20 Hepatitis and retroviruses Respiratory viruses Bacterial pathogens (syphilis) Herpes viruses Yes No Number of NBs 5 2 3 3 3 5 14 17 16 16 16 14 0 5 10 15 20 Hepatitis and retroviruses Respiratory viruses Bacterial pathogens (syphilis) Herpes viruses Parasites Blood grouping Yes No Number of NBs Hepatitis and retroviruses Respiratory viruses Bacterial pathogens Herpes virus TOTAL Total number of class D devices (covered by an application lodged [from 01/10/2024 up to 28/02/2026]) that fall in the categories of currently designated EURLs 270 37 41 9 357 Number of devices covered by a signed master services agreement with an EURL for performance verification (EURL task in IVDR Article 100(2)(a) [as of 28/02/2026] 438 9 30 27 504 Number of devices that is or was covered by a signed statement of work with an EURL for performance verification (EURL task in IVDR Article 100(2)(a)) [as of 28/02/2026] 25 0 0 0 25 Number of devices for which performance verification by EURLs has been scheduled or completed [as of 28/02/2026] 81 0 0 0 81 49 Collaboration with EU reference laboratories (EURLs) on Class D devices (2) Class D applications IVD Data of 9 NBs designated under IVDR Hepatitis and retrovirus Respiratory viruses Bacterial pathogens Herpes virus Parasites Blood grouping TOTAL Total number of class D devices (covered by issued certificates [as of 28/02/2026]) that fall in the categories of currently designated EURLs* 477 19 37 45 8 181 767 Number of devices covered by a signed master services agreement with an EURL for batch testing (EURL task in IVDR Article 100(2)(b)) [as of 28/02/2026]* 468 8 33 29 3 73 614 Number of devices covered by a signed statement of work with an EURL for patch testing (EURL task in IVDR Article 100(2)(a)) [as of 28/02/2026] 412 8 29 27 n. a. n. a. 476 Number of devices for which batch testing by EURLs is in practical operation [as of 28/02/2026]** 190 3 0 0 n. a. n. a. 193 Number of batches tested by an EURL from the date on which the corresponding EURLs became available for tasks in conformity assessment (1 October 2024) [as of 28/02/2026]* Note: cumulative sum across devices in category 813 28 0 0 n. a. n. a. 841 Number of batches tested by alternative means (e.g. by an independent testing laboratory) from the date on which the corresponding EURLs became available for tasks in conformity assessment (1 October 2024) [as of 28/02/2026]*** 373 0 13 5 n. a. n. a. 391 50 Collaboration with EU reference laboratories (EURLs) on Class D devices (3) Class D certificates IVD Data of 5 NBs designated under IVDR n.a. = data not available (question was not asked in the survey) * This question was asked in the 20th NB survey for the first time for the following two categories: Parasites, Blood grouping. ** Note: this refers to the overall process being in place in practice, and not whether a batch is being tested at the time of reporting. *** This question was asked in the 18th NB survey for the first time. 51 Comparison of EURLs results • 14th NB survey: data of 4 NBs designated under IVDR • 16th NB survey: data of 8 NBs designated under IVDR • 18th NB survey: data of 9 NBs designated under IVDR • 20th NB survey: data of 9 NBs designated under IVDR • 14th NB survey: data of 3 NBs designated under IVDR • 16th NB survey: data of 3 NBs designated under IVDR • 18th NB survey: data of 4 NBs designated under IVDR • 20th NB survey: data of 5 NBs designated under IVDR * This question was not asked in this survey round. n.a. = not available; ** Differing questions in the 16th and 18th NB surveys: • 16th NB survey: Number of batches tested [as of 30/06/2025] • 18th NB survey: Number of batches tested by an EURL from the date on which the corresponding EURLs became available for tasks in conformity assessment (1 October 2024) [as of 31/10/2025] 24 23 0 4 124 397 14 14 168 496 22 50 357 504 25 81 0 100 200 300 400 500 600 Total number of class D devices (covered by an application lodged) that fall in the categories of currently designated EURLs Number of devices covered by a signed master services agreement with an EURL for performance verification (EURL task in IVDR Article 100(2)(a) Number of devices that is or was covered by a signed statement of work with an EURL for performance verification (EURL task in IVDR Article 100(2)(a)) Number of devices for which performance verification by EURLs has been scheduled or completed Class D applications 14th NB survey [as of 28/02/2025] 16th NB survey [as of 30/06/2025] 18th NB survey [as of 31/10/2025] 20th NB survey [as of 28/02/2026] 222 139 91 41 n.a.* n.a.* 564 388 340 78 221** n.a.* 619 589 476 165 504** 294 767 614 476 193 841 391 0 100 200 300 400 500 600 700 800 900 Total number of class D devices (covered by issued certificates) that fall in the categories of currently designated EURLs Number of devices covered by a signed master services agreement with an EURL for batch testing (EURL task in IVDR Article 100(2)(b) Number of devices covered by a signed statement of work with an EURL for batch testing (EURL task in IVDR Article 100(2)(b)) Number of devices for which batch testing by EURLs is in practical operation Number of batches tested by an EURL from the date on which the corresponding EURLs became available for tasks in conformity assessment (1 October 2024) Number of batches tested by alternative means from the date on which the corresponding EURLs became available for tasks in conformity assessment Class D certificates 14th NB survey [as of 28/02/2025] 16th NB survey [as of 30/06/2025] 18th NB survey [as of 31/10/2025] 20th NB survey [as of 28/02/2026] 12 4 3 1 0 0 0 2 4 6 8 10 12 14 Other Wrong qualification of product/classification of device Application not complete Insufficient notified body resources Wrong conformity assessment procedure Outside the scope of notified body's designation Reasons for refusal 52 IVDR applications - reason for refusal Total number of IVDR application refusals*: October 2022: 2 March 2023: 49 June 2023: 16 October 2023: 6 February 2024: 7 June 2024: 7 October 2024: 7 February 2025: 12 June 2025: 14 October 2025: 111 February 2026: 145 February 2026 Main reasons for refusals: “Other” (60%) IVD Notes: • * Applications can have multiple reasons for refusal; the total number shown is derived from the small data set and differ from the figures in the medium data set indicated on the graph on this slide." • February 2026: ”Other” reasons: “not able to complete conformity assessment process”, “client stopped communication”, “cancelled by the manufacturer”. February 2026 IVDR Applications: 3.418 IVDR Certificates: 2.318 Completeness of submissions * Estimated percentage of submissions which were deemed satisfactory in terms of documentation provided (before undertaking the review of its content) without requesting for any additional information 53 N um be r o f n ot ifi ed b od ie s IVD Number of notified bodies which report that > 50% of submissions are considered complete: 5 out of 19 NBs in February 2026 2 4 2 2 2 2 2 3 5 4 6 83 3 6 5 7 7 7 8 6 7 6 6 1 0 1 2 1 1 2 2 3 5 6 4 0 0 1 1 2 2 1 0 0 1 1 1 0 2 4 6 8 10 12 14 16 18 20 April 2022 October 2022 March 2023 June 2023 October 2023 February 2024 June 2024 October 2024 February 2025 June 2025 October 2025 February 2026 Completeness of submissions expressed by notified bodies (in percent of notified bodies) (Annex VII, Section 4.3) – survey comparison Less than 25 % 25-50 % 51-75 % More than 75 % Submissions remain incomplete* 229 1.026 876 540 323 134 0 200 400 600 800 1.000 1.200 1-2 weeks 3-4 weeks 1 to 2 months 2 to 3 months 3 to 6 months >6 months Number of files Average timeframe between application lodged and written agreement signed 54 Average timeframe to written agreement signed Note: Data of 19 NBs designated under IVDR In the majority of the cases (68%), it takes less than 2 months from an application lodged to a written agreement signed. IVD Time to reach a new certificate (QMS vs QMS+PRODUCT) 55 Notes: • This indicator shows the time to reach issuance of a new EC certificate (from written agreement signed to issuance) under IVDR. • QMS+PRODUCT: Data of 12 NBs designated under IVDR • QMS: Data of 12 NBs designated under IVDR IVDR QMS certificates - 42% of NBs: 6-12 months to issue a new QMS certificate - 50% of NBs: 13-18 months IVDR QMS+PRODUCT certificates: longer time - 67% of NBs: 13-18 months - 8% of NBs: 19-24 months IVD Pe rc en ta ge (% ) o f t ot al n um be r o f N B th at h av e is su ed c er tif ic at es February 2026 IVDR Applications: 3.418 IVDR Certificates: 2.318 0% 25% 67% 8% 0% 0% 42% 50% 8% 0% 0% 10% 20% 30% 40% 50% 60% 70% <6 months 6-12 months 13-18 months 19-24 months >24 months Time to reach IVDR certificate (QMS vs QMS+PRODUCT) IVDR_QMS IVDR_QMS+PRODUCT Thank you Contact for questions: medical.devices@goeg.at Austrian National Public Health Institute/ Gesundheit Österreich (GÖG) © European Union 2026 Unless otherwise noted the reuse of this presentation is authorised under the CC BY 4.0 license. For any use or reproduction of elements that are not owned by the EU, permission may need to be sought directly from the respective right holders. 56 mailto:medical.devices@goeg.at https://creativecommons.org/licenses/by/4.0/ Study supporting the �monitoring of the availability�of medical devices on the EU market Disclaimer Acknowledgements Content List of abbreviations (1) List of abbreviations (2) 1. About the study, survey and datasets Study supporting the monitoring of availability of medical devices on the EU market Preliminary notes NB survey overview Dashboard Foliennummer 12 Response rate for the 20th NB survey �(conducted in March 2026 with requested data from designation up to 28/02/2026) 2. Survey results for medical devices Small dataset MDR applications filed and refused, written agreements signed MDR number of QMS / product certificates issued Foliennummer 18 Foliennummer 19 Foliennummer 20 Medium dataset MDR applications filed and �certificates issued (sum of Annexes) MDR applications by annex – �survey comparison MDR certificates by annex - �survey comparison MDR applications and certificates by type �(QMS vs Product) – survey comparison Specific additional procedures �according to Annex IX (II) Average timeframe to written agreement signed MDR applications - reasons for refusal Completeness of submissions Time to reach a new certificate�(QMS vs QMS+PRODUCT) Questions on Annex XVI products �(products with no intended medical purpose that fall under the scope of the MDR) Certificates issued for products without an intended �medical purpose* and for dual purpose devices** Single-use devices and their reprocessing (Article 17 MDR) Article 117 MDR opinions* - requests received and opinions issued 3. Survey results for �in vitro diagnostic medical devices IVDR applications filed and refused, written agreements signed IVDR Number of QMS / product certificates issued Survey comparison – March 2023 to February 2026 Survey comparison – March 2023 to February 2026 Foliennummer 40 Medium dataset IVDR applications lodged and �certificates issued IVDR applications and certificates by annex IVDR applications and certificates by annex – surveys comparison Class D devices �applications and certificates Class D IVDs applications �and certificates development Applications and certificates requiring consultation for companion diagnostics (CDx)* Collaboration with EU reference laboratories (EURLs) on Class D devices (1) Collaboration with EU reference laboratories (EURLs) on Class D devices (2)�Class D applications Collaboration with EU reference laboratories (EURLs) on Class D devices (3)�Class D certificates Comparison of EURLs results IVDR applications - reason for refusal Completeness of submissions Average timeframe to written agreement signed Time to reach a new certificate�(QMS vs QMS+PRODUCT) Thank you��Contact for questions: medical.devices@goeg.at ��Austrian National Public Health Institute/ Gesundheit Österreich (GÖG)

Die Generaldirektion Gesundheit und Lebensmittelsicherheit der Europäischen Kommission (DG SANTE) hat über die Europäische Exekutivagentur für Gesundheit und Digitales (HaDEA) eine „Studie zur Unterstützung der Überwachung der Verfügbarkeit von Medizinprodukten auf dem EU-Markt“ in Auftrag gegeben. Die Studie wurde von einem Konsortium unter Leitung der Gesundheit Österreich GmbH (GÖG) gemeinsam mit Areté und Civic Consulting durchgeführt und lief vom 2. Dezember 2022 bis zum 1. Juni 2026. Untersucht wurden Medizinprodukte und In-vitro-Diagnostika aller Risikoklassen mit besonderem Fokus auf Produkte, für die eine Benannte Stelle eingebunden ist. Die Studie umfasste 31 Länder, darunter die 27 Mitgliedstaaten der Europäischen Union sowie Island, Liechtenstein, Norwegen und die Türkei. Berücksichtigt wurden sowohl bereits auf dem Markt verfügbare Produkte als auch Produkte, die künftig in Verkehr gebracht werden sollen, einschließlich sogenannter „Legacy Devices“ und neuer Produkte nach MDR bzw. IVDR. Im Rahmen der Studie werden regelmäßig Umfragen bei den Benannten Stellen durchgeführt. Die Ergebnisse werden in einem öffentlichen Dashboard veröffentlicht und sollen die Entwicklung der Zertifizierungsaktivitäten sowie die Verfügbarkeit von Medizinprodukten und In-vitro-Diagnostika auf dem europäischen Markt überwachen. Anfang 2026 wurde eine 20. Umfrage durchgeführt, um weitere Informationen zum Stand der Umsetzung der Verordnung (EU) 2017/745 über Medizinprodukte (MDR) und der Verordnung (EU) 2017/746 über In-vitro-Diagnostika (IVDR) zu erheben. Die Datenerhebung bei den Benannten Stellen erfolgte auf Basis von Informationen bis zum 28. Februar 2026. An der Umfrage beteiligten sich alle 53 gemäß MDR und IVDR Benannten Stellen. Die Ergebnisse wurden am 3. Juli 2026 veröffentlicht. Die Umfrage zeigt den aktuellen Stand der MDR-Zertifizierungen. Insgesamt wurden 32.898 MDR-Anträge und 18.010 MDR-Bescheinigungen erfasst. Im Vergleich zur vorherigen Erhebung vom Oktober 2025 hat sich die Zahl der Anträge kaum verändert (33.107), während die Zahl der ausgestellten MDR-Bescheinigungen leicht zunahm (17.507). Die Auswertung enthält zudem detaillierte Angaben zu Anträgen und Zertifizierungen nach Anhängen der MDR sowie nach Art der Konformitätsbewertung (Qualitätsmanagementsysteme und Produktzertifizierungen). Darüber hinaus wurden 1.175 Anträge für Produkte nach Regel 14 MDR gemeldet. Für diese Produkte wurden bislang 387 Zertifikate ausgestellt. Für Produkte nach Regel 21, erster Spiegelstrich, wurden 162 Anträge registriert. Zum Zeitpunkt der Datenerhebung war hierfür noch kein Zertifikat ausgestellt worden. Die Umfrage liefert außerdem aktuelle Erkenntnisse zu der Dauer der Zertifizierungsverfahren. Nach Angaben von 52 Benannten Stellen vergehen im Durchschnitt weniger als zwei Monate zwischen der Einreichung eines Antrags und der Unterzeichnung einer schriftlichen Vereinbarung mit dem Hersteller. Hinsichtlich der Dauer bis zur Zertifikatserteilung zeigt die Umfrage, dass bei 51 % der Einreichungen zwischen 13 und 18 Monate bis zur Ausstellung eines MDR-Zertifikats für Qualitätsmanagementsysteme und Produkte vergehen. Im Oktober 2025 lag dieser Anteil bei 53 %. Insgesamt benötigen 92 % der Verfahren mehr als 13 Monate bis zur Ausstellung eines MDR-Zertifikats. In der vorherigen Erhebung lag dieser Wert bei 89 %. Für Qualitätsmanagementsysteme (QMS) geben 62 % der Benannten Stellen eine Verfahrensdauer von 13 bis 18 Monaten an. Die Ergebnisse verdeutlichen, dass MDR-Zertifizierungsverfahren weiterhin einen erheblichen Zeitaufwand erfordern und sich die Verfahrensdauern gegenüber der vorherigen Erhebung kaum verändert haben.

Seite 1/2 Gemeinsame Bekanntmachung des Paul-Ehrlich-Instituts und des Bundesinstituts für Arzneimittel und Medizinprodukte Umstellung bei der Beantragung von Eingangsnummern (ENR) und EU- Verfahrensnummern (EUV) bei nationalen und dezentralisierten Zulassungsverfahren Ab dem 01. September 2026 steht die PharmNet.Bund-Anwendung zur Beantragung der Eingangsnummer (ENR) und EU-Verfahrensnummer (EUV) bei nationalen und dezentralisierten Verfahren in Zuständigkeit des Paul-Ehrlich-Instituts (PEI), Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel, und des Bundesinstituts für Arzneimittel und Medizinprodukte (BfArM) zur Verfügung. Das digitale Formular „Beantragung ENR und EUV“ im PharmNet.Bund-Portal ermöglicht dem pharmazeutischen Unternehmen vor Antragsstellung die erforderliche ENR und/oder EUV automatisiert anzufordern. Die bisherige Beantragung per E-Mail wird durch die PharmNet.Bund Anwendung abgelöst. Ab dem 01. September 2026 sind alle Antragstellenden gebeten, das digitale Formular im PharmNet.Bund-Portal zu nutzen. Registrierung Für die Nutzung der PharmNet.Bund-Fachanwendung ist eine einmalige Registrierung im System „Registrierung und Benutzerverwaltung“ (RuBen) im PharmNet.Bund-Portal erforderlich – mit der Berechtigung „PharmNet.Bund- Anwendung Formulareinreichung“. Informationen zum Ablauf der Registrierung sowie die Registrierung selbst finden Sie auf der verlinkten Website im PharmNet.Bund- Portal. https://www.pharmnet- bund.de/PharmNet/DE/Service/Benutzerverwaltung/ node.html Informationen zur Anwendung „Formulareinreichung“ Vor der Einreichung eines Zulassungsantrages ist für die oben genannten Zulassungsverfahren vom pharmazeutischen Unternehmen eine ENR und/oder eine EUV zu beantragen. Die relevanten Nummern sollten vom Antragstellenden frühestens ca. vier Wochen vor der Einreichung beantragt werden. Die Nummern werden über das digitale Formular automatisch vergeben. Sobald die beantragten Nummern bereitstehen, erfolgt (ggf. mit zeitlicher Verzögerung) eine automatische E-Mail-Benachrichtigung an den Antragstellenden. Seite 2/2 Die ENR und die EUV sollten immer im Cover Letter sowie bei jedem Schriftverkehr mit der jeweiligen Bundesoberbehörde angegeben werden. Informationsveranstaltung Am 04. August 2026 um 14 Uhr bieten das Paul-Ehrlich-Institut und das BfArM eine gemeinsame Informationsveranstaltung zur Beantragung von ENR und EUV an. Eine vorherige Anmeldung zur Teilnahme ist erforderlich. Melden Sie sich bitte bis spätestens 31. Juli 2026 bei der entsprechenden Veranstaltung im PharmNet.Bund- Portal an. Schulungen und Informationsveranstaltungen für PharmNet.Bund-Anwendungen

Ab dem 1. September 2026 steht die neue PharmNet.Bund-Anwendung zur Beantragung von Eingangsnummern (ENR) und EU-Verfahrensnummern (EUV) für nationale Verfahren sowie MRP und DCP zur Verfügung. Die erforderlichen Nummern können künftig vor Einreichung eines Zulassungsantrags automatisiert über ein digitales Formular angefordert werden. Die bislang genutzte Beantragung per E-Mail entfällt. Im Rahmen einer gemeinsamen Informationsveranstaltung stellen BfArM und PEI die neue Fachanwendung vor und erläutern die Regelungen zur Beantragung von ENR und EUV, die Voraussetzungen für die Nutzung sowie die grundlegenden Funktionalitäten des Systems. Für die Nutzung der Anwendung ist eine einmalige Registrierung im PharmNet.Bund-Portal über das System „Registrierung und Benutzerverwaltung“ (RuBen) erforderlich. Die kostenfreie Online-Veranstaltung findet am 4. August 2026 um 14 Uhr statt. Eine Anmeldung ist bis zum 31. Juli 2026 über das PharmNet.Bund-Portal möglich. Weitere Informationen sind dem Infoschreiben zu entnehmen. Die Anmeldung zur Veranstaltung finden Sie auf der BfArM-Website .

Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 © European Medicines Agency, 2026. Reproduction is authorised provided the source is acknowledged. 6 July 20261 EMA/PRAC/124080/2026 Pharmacovigilance Risk Assessment Committee (PRAC) PRAC recommendations on signals Adopted at the 8-11 June 2026 PRAC meeting This document provides an overview of the recommendations adopted by the Pharmacovigilance Risk Assessment Committee (PRAC) on the signals discussed during the meeting of 8-11 June 2026 (including the signal European Pharmacovigilance Issues Tracking Tool [EPITT]2 reference numbers). PRAC recommendations to provide supplementary information are directly actionable by the concerned marketing authorisation holders (MAHs). PRAC recommendations for regulatory action (e.g. amendment of the product information) are submitted to the Committee for Medicinal Products for Human Use (CHMP) for endorsement when the signal concerns Centrally Authorised Products (CAPs), and to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) for information in the case of Nationally Authorised Products (NAPs). Thereafter, MAHs are expected to take action according to the PRAC recommendations. When appropriate, the PRAC may also recommend the conduct of additional analyses by the Agency or Member States. MAHs are reminded that in line with Article 16(3) of Regulation No (EU) 726/2004 and Article 23(3) of Directive 2001/83/EC, they shall ensure that their product information is kept up to date with the current scientific knowledge including the conclusions of the assessment and recommendations published on the European Medicines Agency (EMA) website (currently acting as the EU medicines webportal). For CAPs, at the time of publication, PRAC recommendations for update of product information have been agreed by the CHMP at their plenary meeting (22-25 June 2026) and corresponding variations will be assessed by the CHMP. For nationally authorised medicinal products, it is the responsibility of the National Competent Authorities (NCAs) of the Member States to oversee that PRAC recommendations on signals are adhered to. Variations for CAPs are handled according to established EMA procedures. MAHs are referred to the available guidance. Variations for NAPs (including via mutual recognition and decentralised procedures) are handled at national level in accordance with the provisions of the Member States. 1 Expected publication date. The actual publication date can be checked on the webpage dedicated to PRAC recommendations on safety signals. 2 The relevant EPITT reference number should be used in any communication related to a signal. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/signal-management/prac-recommendations-safety-signals https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/signal-management/prac-recommendations-safety-signals https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/signal-management/prac-recommendations-safety-signals PRAC recommendations on signals EMA/PRAC/124080/2026 Page 2/11 The timeline recommended by PRAC for submission of variations following signal assessment is applicable to both innovator and generic medicinal products, unless otherwise specified. For procedural aspects related to the handling of PRAC recommendations on signals (e.g. submission requirements, contact points, etc.) please refer to the Questions and Answers on signal management. https://www.ema.europa.eu/documents/other/questions-answers-signal-management_en.pdf PRAC recommendations on signals EMA/PRAC/124080/2026 Page 3/11 1. Recommendations for update of the product information3 1.1. Darolutamide – Angioedema Authorisation procedure Centralised EPITT No 20237 PRAC Rapporteur Jan Neuhauser (AT) Date of adoption 11 June 2026 Recommendation Having considered the available evidence in EudraVigilance, including the submitted cumulative review and additional data on time to onset, the PRAC has agreed that the MAH of Nubeqa (Bayer AG) should submit a variation within 2 months from the publication of the PRAC recommendation, to amend the product information as described below (new text underlined): Summary of product characteristics 4.8 Undesirable effects Table 1 Under SOC Skin and subcutaneous tissue disorders with frequency “Not known” Angioedema g, h g Includes laryngeal oedema, lip swelling, swelling face, and swollen tongue h Spontaneous reports from post-marketing experience Package leaflet 4 Possible side effects Other side effects that have been reported with frequency not known (cannot be estimated from the available data): - swelling under the skin in areas such as the face, lips, tongue and throat 1.2. Gemcitabine – Drug reaction with eosinophilia and systemic symptoms (DRESS) Authorisation procedure Non-centralised EPITT No 20256 PRAC Rapporteur Jenny Jönsson (SE) Date of adoption 11 June 2026 3 Translations in all official EU languages of the new product information adopted by PRAC are also available to MAHs on the EMA website. https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/signal-management/prac-recommendations-safety-signals PRAC recommendations on signals EMA/PRAC/124080/2026 Page 4/11 Recommendation Having considered all the available evidence, including data from EudraVigilance and the literature, including the comments received by the Marketing Authorisation Holder/s (MAH/s) of gemcitabine (CHEPLAPHARM ARZNEIMITTEL GMBH and SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.), the PRAC has agreed that the MAHs of all gemcitabine-containing medicinal products should submit a variation within 2 months from the publication of the PRAC recommendation, to amend the product information as described below (new text underlined, text to be deleted strikethrough). Considering the already existing wording in some nationally authorised products the text may need to be adapted by MAH/s to individual products. Summary of product characteristics 4.4 Warning and precautions for use Severe cutaneous adverse reactions (SCARs) Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), which can be life-threatening or fatal, have been reported in association with gemcitabine treatment (see section 4.8). Patients should be advised of the signs and symptoms of the severe cutaneous adverse reactions and should seek medical advice from their physician immediately when observing any indicative signs or symptoms. and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, gemcitabine should be withdrawn immediately and an alternative treatment considered (as appropriate). If the patient has developed a severe cutaneous adverse reaction with the use of gemcitabine, treatment with gemcitabine must not be restarted at any time. 4.8 Undesirable effects Tabulated list of adverse reactions Skin and subcutaneous tissue disorders SOC: Frequency: Not known Drug reaction with eosinophilia and systemic symptoms (DRESS) Package leaflet 2. What you need to know before you take Gemcitabine Warnings and precautions Talk to your doctor before using gemcitabine if: • you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after using gemcitabine. Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis (AGEP) have been reported in association with gemcitabine PRAC recommendations on signals EMA/PRAC/124080/2026 Page 5/11 treatment. Seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4. This medicine can cause serious skin reactions. Seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4. 4. Possible side effects You should contact your doctor immediately if you develop any of the following symptoms: (Note: Add the following heading, if the existing one differs and does not adequately reflect the urgency of the required action, ensuring it applies to all listed severe cutaneous adverse reactions: “Seek medical attention immediately if you notice any of the following symptoms of serious skin reactions:”) • Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome) (frequency: not known). 1.3. Valproate and related substances4 – Neurodevelopmental disorders with paternal exposure Authorisation procedure Non-centralised EPITT No 20191 PRAC Rapporteur Liana Martirosyan (NL) Date of adoption 11 June 2026 Recommendation Taking into account the available evidence in the literature, the PRAC considers there remains uncertainty regarding the risk of NDD after paternal exposure to valproate during the spermatogenic risk window and therefore this remains an important potential risk. The PRAC agreed to maintain the precautionary measures in the product information and additional risk minimisation measures. The final report of the PASS TANGO study will be awaited before considering any major changes to the current risk minimisation measures in place considering the inconsistent results in the currently available studies. However, an update on the information provided in the product information is necessary, as the current product information only describes the results of the paternal PASS whereas other available (epidemiological) studies have shown variable results. It is considered important to reflect this in the product information for transparency, to ensure that HCPs and patients have access to accurate and up-to-date information, and to acknowledge the totality of available evidence on this potential risk. The aRMM should be updated in line with the proposed PI updates. Therefore, the PRAC has agreed that the MAHs of valproate containing products should submit a variation within 2 months from the publication of the PRAC recommendation, to amend the product information as described below taking into account the already existing wording in some nationally authorised products the text needs to be adapted by MAHs to individual products (new text underlined and in bold and deletions in strikethrough): Summary of product characteristics 4.4 Special warnings and precautions for use Use in male patients 4 Valproic acid, sodium valproate, valproate semisodium, valpromide PRAC recommendations on signals EMA/PRAC/124080/2026 Page 6/11 A retrospective observational study suggests an increased risk of neuro-developmental disorders (NDDs) in children born to men treated with valproate in the 3 months prior to conception compared to those born to men treated with lamotrigine or levetiracetam. However, other studies do not suggest an increased risk of NDDs after paternal valproate exposure. Thus, available evidence is inconsistent and the causal role of valproate is uncertain (see section 4.6). As a precautionary measure, prescribers should inform male patients about this potential risk (see section 4.6) and discuss the need to consider effective contraception, including for a female partner, while using valproate and for at least 3 months after treatment discontinuation. Male patients should not donate sperm during treatment and for at least 3 months after treatment discontinuation. Male patients treated with valproate should be regularly reviewed by their prescriber to evaluate whether valproate remains the most suitable treatment for the patient. For male patients planning to conceive a child, suitable treatment alternatives should be considered and discussed with the male patients. Individual circumstances should be evaluated in each case. It is recommended that advice from a specialist experienced in the management of <epilepsy> <bipolar disorder> <or> <migraine> should be sought as appropriate. Educational materials are available for healthcare professionals and male patients. A patient guide should be provided to male patients using valproate. 4.6 Fertility, pregnancy and lactation Males and potential risk of neuro-developmental disorders in children of fathers treated with valproate in the 3 months prior to conception A retrospective observational study in 3 Nordic countries suggests an increased risk of neuro- developmental disorders (NDDs) in children (from 0 to 11 years old) born to men treated with valproate as monotherapy in the 3 months prior to conception compared to those born to men treated with lamotrigine or levetiracetam as monotherapy, with a pooled adjusted hazard ratio (HR) of 1.50 (95% CI: 1.09-2.07). The adjusted cumulative risk of NDDs ranged between 4.0% to 5.6% in the valproate group versus between 2.3% to 3.2% in the composite lamotrigine/levetiracetam group. The study was not large enough to investigate associations with specific NDD subtypes and study limitations included potential confounding by indication and differences in follow-up time between exposure groups. The mean follow-up time of children in the valproate group ranged between 5.0 and 9.2 years compared to 4.8 and 6.6 years for children in the lamotrigine/levetiracetam group. Overall an increased risk of NDDs in children of fathers treated with valproate in the 3 months prior to conception is possible however the causal role of valproate is not confirmed. In addition, the study did not evaluate the risk of NDDs to children born to men stopping valproate for more than 3 months prior to conception (i.e., allowing a new spermatogenesis without valproate exposure). Other observational population-based studies did not show an increased risk of NDDs in children born to men treated with valproate as monotherapy in the 3–4 months prior to conception compared with men treated with lamotrigine or levetiracetam as monotherapy. Differences in study design, including control for confounding and population selection, may contribute to differences in study findings. In addition, available data suggest that factors other than valproate exposure, including underlying paternal disease, may contribute to the observed association. Overall, the evidence regarding an increased risk of NDDs in children of fathers treated with valproate in the 3 months prior to conception is inconsistent, and the causal role of valproate is uncertain. PRAC recommendations on signals EMA/PRAC/124080/2026 Page 7/11 As a precautionary measure, prescribers should inform male patients about this potential risk and discuss the need to consider effective contraception, including for a female partner, while using valproate and for at least 3 months after treatment discontinuation (see section 4.4). Male patients should not donate sperm during treatment and for at least 3 months after treatment discontinuation. Male patients treated with valproate should be regularly reviewed by their prescriber to evaluate whether valproate is the most suitable treatment for the patient. For male patients planning to conceive a child, suitable treatment alternatives should be considered and discussed with the male patients. Individual circumstances should be evaluated in each case. It is recommended that advice from a specialist experienced in the management of <epilepsy> <bipolar disorder> <or> <migraine> should be sought as appropriate. Package leaflet 2 What you need to know before you take <product name> Important advice for male patients Potential risks related to taking valproate in the 3 months before conception of a child A study suggests a possible risk of movement and mental developmental disorders (problems with early childhood development) in children born to fathers treated with valproate in the 3 months before conception. In this study, around 5 children in 100 had such disorders when born to fathers treated with valproate as compared to around 3 children in 100 when born to fathers treated with lamotrigine or levetiracetam (other medicines that can be used to treat your disease). The risk for children born to fathers who stopped valproate treatment 3 months (the time needed to form new sperm) or longer before conception is not known. The study has limitations and therefore it is not clear if the increased risk for movement and mental developmental disorders suggested by this study is caused by valproate. The study has limitations and was not large enough to show which particular specific type of movement and mental developmental disorder children may be at risk of developing. Other studies did not suggest an increased risk of mental developmental disorders (problems with early childhood development) in children born to fathers treated with valproate in the 3-4 months before conception. In these studies the risk was similar compared to children of fathers treated with lamotrigine or levetiracetam before conception. Differences in how these studies were designed may explain the different results. Overall, it is not known whether any possible risk of childhood developmental disorders is caused by valproate itself or by other factors, such as the father’s underlying medical condition. As a precautionary measure, your doctor will discuss with you: •The potential risk in children born to fathers treated with valproate • The need to consider effective contraception (birth control) for you and your female partner during treatment and for 3 months after stopping treatment • The need to consult your doctor when you are planning to conceive a child and before stopping contraception (birth control) • The possibility of other treatments that can be used to treat your disease, depending on your individual situation Do not donate sperm when taking valproate and for 3 months after stopping valproate. Talk to your doctor if you are thinking about having a baby. PRAC recommendations on signals EMA/PRAC/124080/2026 Page 8/11 If your female partner becomes pregnant while you used valproate in the 3 months period before conception and you have questions, contact your doctor. Do not stop your treatment without talking to your doctor. If you stop your treatment, your symptoms may become worse. You should get regular appointments with your prescriber. During this visit your doctor will discuss with you the precautions associated with valproate use and the possibility of other treatments that can be used to treat your disease, depending on your individual situation. Make sure you read the patient guide that you will receive from your doctor. You will also receive a Patient Card from your pharmacist to remind you of the potential risks of valproate. 1.4. X-ray contrast agents: iobitridol; iodixanol; iohexol; iomeprol; iopamidol; iopromide; ioversol; ioxitalamic acid – Fixed drug eruption Authorisation procedure Non-centralised EPITT No 20229 PRAC Rapporteur Pernille Harg (NO) Date of adoption 11 June 2026 Recommendation Having considered the available evidence in EudraVigilance and the literature, including the cumulative review submitted by the Marketing Authorisation Holders (MAHs), the PRAC has agreed that the MAHs of products containing iomeprol, iodixanol, ioversol, iopromide, iopamidol, iohexol, iobitridol and ioxitalamic acid should submit a variation within two months from the publication of the PRAC recommendation, to amend the product information as described below (new text underlined): Summary of product characteristics 4.8 Undesirable effects Under SOC Skin and subcutaneous tissue disorders with frequency ‘Not known’ Fixed drug eruption Package leaflet 4 Possible side effects Under section side effects reported/described with frequency ‘Not known’ (frequency cannot be estimated from the available data) An allergic skin reaction that may include round or oval patches of redness and swelling of the skin, blistering, and itching (fixed drug eruption). Darkening of the skin in affected areas, which might persist after healing, may also occur. Fixed drug eruption usually reoccurs at the same site(s) if the medication is <taken> <used> again. Taking into account the already existing wording in some nationally authorised products the text may need to be adapted by MAHs to individual products. PRAC recommendations on signals EMA/PRAC/124080/2026 Page 9/11 1.5. Zolbetuximab – Protein-losing gastroenteropathy Authorisation procedure Centralised EPITT No 20236 PRAC Rapporteur Bianca Mulder (NL) Date of adoption 11 June 2026 Recommendation Having considered the available evidence in EudraVigilance and literature, including the cumulative review submitted by the Marketing Authorisation Holder (MAH), the PRAC has agreed that the MAH of Vyloy, Astellas Pharma Europe B.V. should submit a variation within 2 months from the publication of the PRAC recommendation, to amend the product information as described below (new text underlined): Summary of product characteristics 4.8 Undesirable effects The following adverse reactions should be added under the SOC Gastrointestinal disorders: Gastritis (frequency: uncommon) Protein-losing gastroenteropathy (frequency: not known) Package leaflet 4. Possible side effects Other possible side effects: Uncommon (may affect up to 1 in 100 people) Inflammation of the stomach lining (gastritis) Other side effects that have been reported with frequency not known (cannot be estimated from the available data) Loss of protein from the digestive tract (protein-losing gastroenteropathy) PRAC recommendations on signals EMA/PRAC/124080/2026 Page 10/11 2. Recommendations for submission of supplementary information INN Signal (EPITT No) PRAC Rapporteur Action for MAH MAH Abemaciclib; palbociclib; ribociclib Progressive multifocal leukoencephalopathy (PML) (20271) Marie Louise Schougaard Christiansen (DK) Supplementary information requested (submission by 26 August 2026) Eli Lilly Nederland B.V., Novartis Europharm Limited, Pfizer Europe MA EEIG Atezolizumab; avelumab; cemiplimab; dostarlimab; durvalumab; ipilimumab; nivolumab; nivolumab / relatlimab; pembrolizumab; retifanlimab; serplulimab; sugemalimab; tislelizumab; toripalimab; tremelimumab Acquired haemophilia (20279) Bianca Mulder (NL) Supplementary information requested (submission by 26 August 2026) Accord Healthcare S.L.U., AstraZeneca AB, Beone Medicines Ireland Limited, Bristol-Myers Squibb Pharma EEIG, Cstone Pharmaceuticals Ireland Limited, GlaxoSmithKline Trading Services Limited, Incyte Biosciences Distribution B.V., Merck Europe B.V., Merck Sharp & Dohme B.V., Regeneron Ireland Designated Activity Company (DAC), Roche Registration GmbH, Topalliance Biosciences Europe Limited Belzutifan Retinal oedema (20278) Dennis Lex (DE) Assess in the ongoing PSUR (submission by 5 August 2026 with the MAH comments to the PSUR preliminary assessment report) Merck Sharp & Dohme B.V. PRAC recommendations on signals EMA/PRAC/124080/2026 Page 11/11 INN Signal (EPITT No) PRAC Rapporteur Action for MAH MAH Cefpodoxime Drug interaction between cefpodoxime and proton pump inhibitor (PPIs) resulting in a potentially reduced efficacy of cefpodoxime (20280) Amelia Cupelli (IT) Supplementary information requested (submission by 26 August 2026) Teofarma, Scharper SpA, Zentiva France Lithium Drug interaction between lithium and GLP-1 agonists leading to increased lithium levels (20275) Dennis Lex (DE) Supplementary information requested (submission by 26 August 2026) Teva, Laboratoires Delbert, Teofarma, Oba Pharma Luspatercept Ventilation perfusion mismatch (20281) Jo Robays (BE) Assess in the next PSUR (submission by 2 September 2026) Bristol -Myers Squibb Pharma Osimertinib Pulmonary alveolar haemorrhage (20284) Bianca Mulder (NL) Assess in the next PSUR (submission by 10 February 2027) AstraZeneca AB 3. Other recommendations INN Signal (EPITT No) PRAC Rapporteur Action for MAH MAH Vortioxetine Acute pancreatitis (20234) Jo Robays (BE) Routine pharmacovigilance MAHs of vortioxetine- containing products 1. Recommendations for update of the product information2F 1.1. Darolutamide – Angioedema Recommendation 1.2. Gemcitabine – Drug reaction with eosinophilia and systemic symptoms (DRESS) Recommendation 1.3. Valproate and related substances3F – Neurodevelopmental disorders with paternal exposure Recommendation 1.4. X-ray contrast agents: iobitridol; iodixanol; iohexol; iomeprol; iopamidol; iopromide; ioversol; ioxitalamic acid – Fixed drug eruption Recommendation 1.5. Zolbetuximab – Protein-losing gastroenteropathy Recommendation 2. Recommendations for submission of supplementary information 3. Other recommendations