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Die EMA stellt viermal im Jahr den aktuellen Sachstand und den geplanten Ausbau ihrer IT-Projekte vor. Am 25. Juni 2026 von 9:00 bis 12:45 Uhr wird die zweite Systemdemonstration für dieses Jahres zu einigen der laufenden IT-Projekte unter Verantwortung der Europäischen Arzneimittel-Agentur (EMA) stattfinden. Die EMA berichtet über den Sachstand der aktuellen Projekte, die sie nach eigenen Konzepten entwickelt. Zur Vorplanung der Teilnahme hat sie die Themen der geplanten Vorträge auf der Veranstaltungsseite und ergänzend in einer Agenda zur Veranstaltung veröffentlicht (geplante Uhrzeit des Vortrags vorangestellt): 09:05 CEST: Union Product Database (UPD) 09:15 CEST: Regulatory Procedure Management (RPM) for Product Lifecycle Management on IRIS 09:45 CEST: Electronic Product Information (ePI) 10:00 CEST: Electronic Common Technical Document version 4 (eCTD v4.0) 10:15 CEST: Electronic Application Form (eAF) 10:40 CEST: Product Management Service (PMS) 10:55 CEST: Product User Interface (PUI) 11:15 CEST: EudraGMDP 11:40 CEST: Clinical Trials Information System (CTIS) modernisation 12:20 CEST: EMA Account Management Sofern die Themen einen eigenen Bereich im Internetauftritt der EMA haben, ist dieser direkt verlinkt. Näheres, besonders die Namen der Referenten, kann man dem Entwurf der Agenda zur Veranstaltung entnehmen. Die EMA veröffentlicht im Nachhinein einen Videomittschnitt der Veranstaltung sowie eine Zusammenfassung der gestellten Fragen. Pharma Deutschland wird seine Mitglieder darüber informieren, sobald diese Informationen verfügbar sind. Die Veranstaltung wird live übertragen, der Zugang zum Livestream erfolgt über die Veranstaltungsseite . Eine Anmeldung ist nicht notwendig. Pharma Deutschland wird seine Mitglieder kontinuierlich über die weitere Entwicklung der IT-Projekte auf europäischer Ebene unterrichten.

Im Rahmen dieses Online-Workshops sollen die Änderungen, die von der EMA gemeinsam mit den zuständigen nationalen Behörden der Mitgliedstaaten und der Europäischen Kommission im Einklang mit der neuen Arzneimittelgesetzgebung und unter Berücksichtigung der Erkenntnisse aus dem Pilotprojekt zu den Plänen zur Verhinderung von Engpässen (SPP) und zur Minderung von Engpässen (SMP) im Jahr 2025 vorgeschlagen wurden, vorgestellt werden. Dieser Workshop folgt jetzt auf eine Konsultation mit den Industrieverbänden, bei der Rückmeldungen zu der vorgeschlagenen aktualisierten Vorlage und den Leitlinien sowie zu den geplanten nächsten Schritten eingeholt wurden. Die Teilnehmer:Innen sollen einen Überblick über die Änderungen, den Zeitplan und die Datenelemente, die Unternehmen auf Anfrage der Regulierungsbehörden gemäß der bevorstehenden Gesetzgebung vorlegen müssen, erhalten. In speziellen interaktiven Sitzungen können die Teilnehmer Fragen stellen und Feedback geben. Der Workshop richtet sich an benannte Teilnehmer aus berechtigten Branchenverbänden. Die Europäische Kommission, die nationalen zuständigen Behörden und die EMA werden ebenfalls teilnehmen. Die EMA will die Tagesordnung des Workshops und einen Workshop-Bericht kurz nach der Veranstaltung veröffentlichen. Weitere Informationen finden sich auf der entsprechenden Webseite der EMA .

The European Association of Medical devices Notified Bodies Team-NB Position Paper TEAM-NB Team-NB-PositionPaper-IVDR-Application-and-appropriate-surveillance-Transfer- agreement-V1-20260610.docx Page 1/13 Editor : Team-NB Adoption date 10/06/2026 Version 1 AGREEMENT RELATED TO THE TRANSFER OF IVDR FORMAL APPLICATION AND OF APPROPRIATE SURVEILLANCE OF LEGACY DEVICES specifying the terms of the transfer of Article 110 (3e) application(s) with, where applicable, the transfer of the appropriate surveillance activities according to Article 110 (3e) of Regulation (EU) 2017/7461 in respect of legacy devices covered by a certificate issued in accordance with Directive 98/79/EC Note: “Transfer of IVDR formal application” is intended to address the answer to question 7.1 of the “Q&A on practical aspects related to the implementation of the extended transitional period provided for in the IVDR, as amended by Regulation (EU) 2024/1860 of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices” and it covers the transfer of the regulatory status of the IVDR application and the transfer of the regulatory status of the formal written agreement. The company (legal manufacturer that submitted a IVDR formal application for conformity assessment activities to the OUTGOING NB) <customer name> <customer address> - hereinafter referred to as “APPLICANT” , The company (legal manufacturer of the legacy devices subject to transfer of appropriate surveillance) ☐ N.A., no appropriate surveillance to be transferred or ☐ Same as “APPLICANT” or <customer name> <customer address> 1 As amended by Regulation (EU) 2024/1860 of the European Parliament and of the Council of 13 June 2024 Autor Instructions: In case the IVDR legal manufacturer and the IVDD legal manufacturer are different, the transfer can happen only if the legal manufacturer under IVDR formal application and written agreement and the legal manufacturer holding the IVDD certificate are part of the same large organisation (refer to Q&A on practical aspects related to the implementation of Regulation (EU) 2024/1860, question 7.2). If there are more than one IVDD legal manufacturer involved, copy and paste this section as needed. Autor Tick if the certification holder is the same as the applicant. If the certification holder is different than the applicant, provide the customer name and address of the certification holder. The European Association of Medical devices Notified Bodies Team-NB Position Paper TEAM-NB Team-NB-PositionPaper-IVDR-Application-and-appropriate-surveillance-Transfer- agreement-V1-20260610.docx Page 2/13 - hereinafter referred to as “CERTIFICATION HOLDER” , The notified body with the identification number: <XXXX> <Incoming NB name> <Incoming NB address> - hereinafter referred to as “INCOMING NB” -, and The notified body with the identification number: <XXXX> <Outgoing NB name> <Outgoing NB address> - hereinafter referred to as “OUTGOING NB” - Have concluded the following Agreement under the TRANSFER DATE effective as specified in Appendix 1. Preamble: It is necessary to ensure transfer from one notified body to another notified body even after the relevant deadlines without impacting the fulfilment of the conditions set out in Article 110(3c), point (e), IVDR. In such cases, if the APPLICANT or the outgoing NB terminates the existing IVDR written agreement and the APPLICANT simultaneously enters into a new written agreement with another notified body, to which the IVDR formal application is transferred, the conditions set out in Article 110 (3c) point (e) IVDR are considered to be still met and the transitional period continues to apply. The purpose of this Agreement is to ensure that, after the relevant deadlines according to Art. 110(3c) point (e) IVDR, the APPLICANT/CERTIFICATION HOLDER can benefit from the transitional period for their legacy devices in accordance with Art. 110 IVDR, without prejudice to any subsequent activities of the INCOMING NB that may rend it inapplicable. On signing this agreement, the regulatory status of the IVDR formal application at the TRANSFER DATE is retained. Where applicable (i.e. IVDD certified devices), the appropriate surveillance is also transferred to INCOMING NB. The European Association of Medical devices Notified Bodies Team-NB Position Paper TEAM-NB Team-NB-PositionPaper-IVDR-Application-and-appropriate-surveillance-Transfer- agreement-V1-20260610.docx Page 3/13 § 1 AGREEMENT RELATED TO THE TRANSFER OF THE IVDR FORMAL APPLICATION § 1.1 Scope 1. This Agreement specifies the terms and modalities for the transfer of the IVDR formal application from an OUTGOING NB to an INCOMING NB in accordance with the applicable requirements of the IVDR and ensures the continuity of the activities between the OUTGOING NB and the INCOMING NB in accordance with the IVDR. The IVDR formal application should be transferred from OUTGOING NB to INCOMING NB in accordance with the applicable requirements of provisions referenced at the end of this Agreement. The new formal application should be considered as fulfilling the conditions of IVDR Article 110(3c, point e). 2. APPLICANT lodged within the relevant deadline a IVDR formal application and concluded a IVDR written agreement for conformity assessment activities to/with the OUTGOING NB (“existing (original) IVDR formal application”) and intends that all of these activities and certification are in future delivered by INCOMING NB. Conformity assessment activities are described in IVDR Annex VII, section 4.5 and are performed by a notified body as part of APPLICANT’s selected conformity assessment procedure pursuant Article 48 of the said Regulation. 3. The devices covered by the IVDR formal application and the written agreement (hereby referred to as “devices covered by the IVDR formal application”) stipulated between the APPLICANT and the OUTGOING NB are identified in Appendix 1, table 1 of this agreement. 4. The APPLICANTS’s IVDR formal application at the OUTGOING NB is transferred to full or in parts to the INCOMING NB on agreed TRANSFER DATE. 5. The WRITTEN AGREEMENT between APPLICANT and OUTGOING NB is terminated only for devices being the subject of the IVDR formal application transfer as stated in Appendix 1, table 1 on agreed TRANSFER DATE. 6. The transfer of the IVDR formal application from OUTGOING NB to INCOMING NB by way of transfer means that, in case the APPLICANT or the OUTGOING NB terminates the existing written agreement and the APPLICANT simultaneously lodges a corresponding IVDR formal application and enters into a new written agreement with INCOMING NB regarding the corresponding devices, the conditions set out in Article 110 (3c) point (e) IVDR are considered to be still met and the transitional period continues to apply, provided that also the other conditions and applicable regulatory requirements are met. The European Association of Medical devices Notified Bodies Team-NB Position Paper TEAM-NB Team-NB-PositionPaper-IVDR-Application-and-appropriate-surveillance-Transfer- agreement-V1-20260610.docx Page 4/13 7. The existing (original) IVDR formal application subject to transfer that has been lodged by APPLICANT at the OUTGOING NB is governed by the terms set out in an IVDR written agreement between APPLICANT and OUTGOING NB until the day preceding the TRANSFER DATE. Similarly, the subsequent IVDR formal application that is lodged by APPLICANT at the INCOMING NB is subject to a separate written agreement between APPLICANT and INCOMING NB starting at 00:00 hours (time zone of INCOMING NB) on AGREED TRANSFER DATE. 8. Where performance verification and/or batch release activities form part of the ongoing conformity assessment of a product, the Manufacturer and the outgoing Notified Body hereby undertake to make available, in full and in a timely manner, all relevant information relating to existing plans and results of such activities. The recipient shall be the incoming Notified Body. At the same time, the Manufacturer and the outgoing Notified Body expressly consent to the disclosure of such information to the aforementioned recipient, insofar as this is necessary to ensure continuity of conformity assessment and testing. This Agreement shall constitute a sufficient basis for the aforementioned obligation and consent. § 1.2 Validity of the IVDR formal application subject to transfer 1. APPLICANT should not withdraw their existing (original) IVDR formal application nor cancel the written agreement subject to transfer specified in Appendix 1, table 1 with OUTGOING NB prior to TRANSFER DATE, as this may invalidate the transfer of the IVDR formal application. 2. OUTGOING NB shall not refuse the APPLICANT’s IVDR formal application subject to transfer specified in Appendix 1, table 1, following the notification that the APPLICANT is transferring to the INCOMING NB, unless, during the conformity assessment activities, the OUTGOING NB finds there is non-compliance with relevant IVDR requirements that lead to a refusal of the APPLICANT’s IVDR formal application or to a refusal of the issuance of a IVDR certificate . 3. The IVDR formal application for devices subject to transfer specified in Appendix 1, table 1, will be fully or partially transferred on the TRANSFER DATE, provided that there is no non-compliance with relevant IVDR requirements that might lead to a refusal of the APPLICANT’s IVDR formal application or to a refusal of the issuance of a IVDR certificate. In case the APPLICANT’s IVDR formal application is about to be rejected but not formally notified to the APPLICANT or the issuance of the certificate is about to be refused but not formally notified to the APPLICANT, INCOMING NB may, according to its own criteria, decide to continue the transfer process. The European Association of Medical devices Notified Bodies Team-NB Position Paper TEAM-NB Team-NB-PositionPaper-IVDR-Application-and-appropriate-surveillance-Transfer- agreement-V1-20260610.docx Page 5/13 § 2 Transfer of the appropriate surveillance activities according to Article 110 (3e) of Regulation (EU) 2017/746 ☐ Not applicable § 2.1 Scope 1. This Agreement specifies the terms and modalities for the transfer of appropriate surveillance from the OUTGOING NB to the INCOMING NB in accordance with the IVDR and other relevant scheme requirements as referred to at the end of this Agreement (see Section “Overview of provisions covered or taken into consideration in this Agreement”) and ensures the continuity of the appropriate surveillance activities between the OUTGOING NB and the INCOMING NB in accordance with such requirements. 2. CERTIFICATION HOLDER underwent conformity assessment activities and holds certification issued by OUTGOING NB in accordance with Directive 98/79/EC (hereinafter referred to as “IVDD”) that is valid by virtue of Article 110 (2) of the Regulation (EU) 2017/746 (hereinafter referred to as “IVDR”) covering a device which is placed on the market after date of application of the IVDR until the date set out in Article 110 (3a) of IVDR (hereinafter referred to as “legacy device 2 ”) that is subject to appropriate surveillance activities in respect of the applicable requirements according to Article 110 (3e) of Regulation (EU) 2017/746 (hereinafter referred to as “appropriate surveillance”), and intends that this appropriate surveillance in respect of that legacy device are in future carried out by the INCOMING NB. Appropriate surveillance 3 can include for example documentation review, audits or other kinds of assessments performed by a notified body in respect of a legacy device (see § 2.3 (1)) of this Agreement as part of CERTIFICATION HOLDER’s previous conformity assessment procedure under IVDD. Certification is a valid confirmation in the form of a certification document, in accordance with this Directive, that conformity assessment activities have been completed successfully and can be supplemented by written confirmations issued by OUTGOING NB 4. 3. The legacy devices that the OUTGOING NB issued a certification for, and which are subject to transferred appropriate surveillance to the INCOMING NB are hereinafter referred to as “legacy devices subject to transfer of appropriate surveillance” and are specified in Appendix 1, table 2. 2 As per MDCG 2022-8 (current revision) Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC 3 MDCG 2022-15 (current revision) , “Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD”. 4 According MDCG 2022-6 (current revision), Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR”. The European Association of Medical devices Notified Bodies Team-NB Position Paper TEAM-NB Team-NB-PositionPaper-IVDR-Application-and-appropriate-surveillance-Transfer- agreement-V1-20260610.docx Page 6/13 The agreed date on which any review activities by the INCOMING NB in accordance with § 3 of this Agreement are to be completed and from which any surveillance activities by the INCOMING NB are to be carried out and the responsibility for the appropriate surveillance assumed by INCOMING NB is hereinafter referred to as “TRANSFER DATE” and is specified in Appendix 1, table 2. 4. Appropriate surveillance may be transferred only in respect of a legacy device for as long as it is included in the scope of a certification considered as valid in accordance with Article 110 (2) of IVDR and issued by an OUTGOING NB covered with the respective designation/notification valid at the time when this certification was issued. Certification, which is suspended or temporarily restricted for the relevant legacy device may not be accepted for transfer of appropriate surveillance in respect of that device, but it is up to the INCOMING NB’s decision and subject to the assessment prior to transfer in accordance with § 3 of this Agreement. Certification, which is withdrawn or otherwise invalidated prior to TRANSFER DATE is not subject to transfer of appropriate surveillance in respect of that device. 5. The transition of appropriate surveillance in respect of a legacy device from OUTGOING NB to INCOMING NB by way of transfer means that the INCOMING NB, when assuming these activities, takes into account, according to its procedures, the appropriate surveillance activities of the OUTGOING NB in respect of that device (see examples in § 2.3(1) of this Agreement). The INCOMING NB has to ensure that adequate rights and obligations are agreed with CERTIFICATION HOLDER on a contractual basis to ensure the performance of appropriate surveillance including the right to suspend, restrict, withdraw or take any other measure relating to the concerned certificates that issued the OUTGOING NB and are subject to this agreement; this includes as well auditing rights e.g. on the premisses of CERTIFICATION HOLDER and their subcontractors/suppliers. 6. The appropriate surveillance subject to transfer performed by OUTGOING NB prior to transfer date is governed by the terms set out in a certification agreement between CERTIFICATION HOLDER and OUTGOING NB. Following the TRANSFER DATE, the OUTGOING NB and the CERTIFICATION HOLDER shall amend or terminate (as applicable) their certification agreements in respect of legacy devices subject to transfer of appropriate surveillance. § 2.2 Validity of certification and notified body appropriate surveillance activities for the legacy devices subject to transfer of appropriate surveillance 1. CERTIFICATION HOLDER shall comply with the requirements of IVDR, Art. 110 with respect to legacy devices subject to transfer of appropriate surveillance specified in Appendix 1, table 2. The European Association of Medical devices Notified Bodies Team-NB Position Paper TEAM-NB Team-NB-PositionPaper-IVDR-Application-and-appropriate-surveillance-Transfer- agreement-V1-20260610.docx Page 7/13 2. OUTGOING NB shall not suspend or withdraw the CERTIFICATION HOLDER’s certification, in respect of legacy devices subject to transfer of appropriate surveillance specified in Appendix 1, table 2, for the only reason as a reaction to the notification that the CERTIFICATION HOLDER is transferring the appropriate surveillance to the INCOMING NB. The rights and duties of the OUTGOING NB to suspend or withdraw certification subject to transfer according to its certification agreement with CERTIFICATION HOLDER remain unaffected until the TRANSFER DATE. 3. Appropriate surveillance, performed by OUTGOING NB, will be fully transferred in respect of the legacy devices specified in Appendix 1, table 2, i.e. equivalent appropriate surveillance will be commenced by the INCOMING NB, on the TRANSFER DATE. 4. CERTIFICATION HOLDER shall continue to apply the notified body identification number of the OUTGOING NB (or previous outgoing NB) to legacy devices subject to transfer of appropriate surveillance, unless otherwise agreed as per Appendix 2. 5. If agreed as per Appendix 2, the change of notified body identification number from OUTGOING NB (or previous outgoing NB) to INCOMING NB number shall be documented for devices in the scope of certification the legacy devices subject to transfer of appropriate surveillance on a product-by-product basis during the agreed TRANSITION SELL-OFF PERIOD. The change of notified body number for each device (catalogue number) shall be documented and fixed to a specific serial number or lot number. CERTIFICATION HOLDER commits to document this change for each device (catalogue number) in Appendix 2 and make this information available upon the request of the INCOMING NB. 6. CERTIFICATION HOLDER commits to inform the OUTGOING NB and INCOMING NB in writing of the dates when the placing on the market of the legacy devices subject to transfer of appropriate surveillance under the notified body surveillance activities of the OUTGOING NB has been discontinued within 30 days after discontinuation. § 2.3 Continued appropriate surveillance 1. Beginning from the agreed TRANSFER DATE, INCOMING NB shall assume full responsibility for the notified body appropriate surveillance activities3 for the legacy device subject to transferred appropriate surveillance, including a. any continuing conformity assessment activities, incl. QMS audits, focused audits (e.g. sterilization, microbiology, supplier etc.), unannounced audits, for cause audits, verification of manufactured products covered by Annex II List A, in accordance with Directive 98/79/EC release activities b. surveillance activities The European Association of Medical devices Notified Bodies Team-NB Position Paper TEAM-NB Team-NB-PositionPaper-IVDR-Application-and-appropriate-surveillance-Transfer- agreement-V1-20260610.docx Page 8/13 c. post-certification monitoring and the assessment of the CERTIFICATION HOLDER’s vigilance system with respect to the legacy device manufactured which is under the transferred appropriate surveillance, including NB’s involvement in vigilance case assessments d. communication with authorities in respect of the legacy device (e.g. COEN/CEFs, classification disputes/decisions), notification to national authorities e. appeals and complaints handling f. continued assessment of changes to the device, e.g. changes which are considered not to be significant as per Art. 110.3 g. continued assessment of changes for the related quality management system h. issuance of written confirmations to supplement or correct information mentioned in the certification document that covers the legacy device5 i. certificate actions: including restriction, suspension and withdrawal of the validity of certification for the legacy device, as well as re-instatement and cancellations. 2. CERTIFICATION HOLDER shall comply with any requirement to notify the relevant authorities about transfer of appropriate surveillance to INCOMING NB. 3. Changes to the certified device(s) including changes on the device list as per Appendix 1, table 2, of this Agreement after the TRANSFER DATE are processed in accordance with the contractual agreements between CERTIFICATION HOLDER and INCOMING NB. a) In the cases where these changes are considered5 as "non-significant change” in the meaning of IVDR, Art. 110(3c) point (b) by the INCOMING NB, such as for example, a limitation in the intended purpose, in respect of this agreement, it means that after the TRANSFER DATE additional devices might be added under the scope of the IVDD certificate without acknowledgement by the OUTGOING NB initially issued the certificate. The addition of such additional devices is considered only possible if for the same devices or its substitute device6 a formal application was lodged with an IVDR Notified Body before 26 May 2025 (or applicable deadline as per Article 110 .2), and written agreement for the IVDR conformity assessment was conducted before 26 September 2025 (or applicable deadline as per Article 110 .2). b) The responsibility of OUTGOING NB for the initial certification remains unaffected. § 3 Assessment prior to transfer INCOMING NB has the full responsibility and authority for the decision regarding the extent of its assessment prior to TRANSFER DATE, and after this Agreement comes into force, based on information provided by CERTIFICATION HOLDER/APPLICANT, OUTGOING NB, and publicly available information. In all cases, prior to transferring the IVDR formal application and, where applicable, prior 5 MDCG 2022-6 “Guidance significant changes regarding the transitional provision under Article 110(3) of the IVDR” paragraph 4.1 current revision. 6 Q14 of the Q&A practical aspects 2024/1860 https://health.ec.europa.eu/document/download/592008f6-3456-4afb-a13a-733a87da1b00_en?filename=mdr_proposal_extension-q-n-a.pdf The European Association of Medical devices Notified Bodies Team-NB Position Paper TEAM-NB Team-NB-PositionPaper-IVDR-Application-and-appropriate-surveillance-Transfer- agreement-V1-20260610.docx Page 9/13 to transferring the appropriate surveillance on the agreed TRANSFER DATE, INCOMING NB shall ensure that an overview is provided by the CERTIFICATION HOLDER/APPLICANT and/or OUTGOING NB of all required assessment activities and their individual status of completion. Any identified unresolved concerns, findings, non-conformities, surveillance notes, etc. shall be addressed based on their criticality in the scheduling/planning of the consecutive activities by the INCOMING NB. § 4 Confidentiality and obligation to provide information In order to allow the INCOMING NB to complete the assessment prior to transfer according to § 3 of this Agreement: 1. CERTIFICATION HOLDER/APPLICANT commits to provide on request to the INCOMING NB any relevant information relating to the assessment of any device subject to this transfer agreement. Such a request may include outcome of application(s) review, assessment reports, consultation reports issued by authorities, non-conformities, corrective actions, complaint records, vigilance records and any other relevant records or information of OUTGOING NB or even another previous notified body. 2. CERTIFICATION HOLDER/APPLICANT approves that OUTGOING NB may disclose to INCOMING NB, from the date when this TRANSFER AGREEMENT comes into force, all information (see items listed in subsection 1 above) related to the assessment and certification of any device subject to this transfer agreement, to enable any direct communication between OUTGOING NB and INCOMING NB that may be required. 3. CERTIFICATION HOLDER/APPLICANT understands that INCOMING NB will contact OUTGOING NB to request information related to any device subject to this transfer agreement. 4. OUTGOING NB understands and approves that CERTIFICATION HOLDER/APPLICANT may disclose to INCOMING NB, from the date when this Agreement comes into force, all information (see items listed in subsection 1) related to any device subject to this transfer agreement. If agreed as per Appendix 2 of this Agreement, the CERTIFICATION HOLDER confirms, for each legacy device subject to modification of the labelling by changing the identification number of the OUTGOING NB (or previous outgoing NB) to the identification number of the INCOMING NB, the last serial number or lot number under the appropriate surveillance of the OUTGOING NB, in accordance with Appendix 2. If this information is not yet known on the date when this TRANSFER AGREEMENT comes into force, or changes occur after the date when this TRANSFER AGREEMENT comes into force, CERTIFICATION HOLDER shall submit to OUTGOING NB and INCOMING NB the last serial number or lot number under the appropriate surveillance of the OUTGOING NB within 30 calendar days of it becoming known or changed. Together with the transfer date, this will allow traceability of devices. The European Association of Medical devices Notified Bodies Team-NB Position Paper TEAM-NB Team-NB-PositionPaper-IVDR-Application-and-appropriate-surveillance-Transfer- agreement-V1-20260610.docx Page 10/13 § 5 Settlement and property rights 1. If not agreed otherwise, CERTIFICATION HOLDER/APPLICANT shall settle, in respect any device subject to this transfer agreement, all outstanding invoices with OUTGOING NB and, as applicable, any affiliate of OUTGOING NB supplying notified body certification services under the control of OUTGOING NB. 2. All documents provided by OUTGOING NB and all documents (assessment reports, certificates, etc.) which were generated by OUTGOING NB for the execution of IVDR conformity assessment activities and for the execution of certification in respect of the legacy device subject to transfer of appropriate surveillance remain property of the OUTGOING NB. 3. All documents provided by INCOMING NB and all documents (assessment reports, etc.) which will be generated by INCOMING NB for the execution of IVDR conformity assessment activities and for the performance of appropriate surveillance in respect of the legacy device subject to transfer of appropriate surveillance remain property of the INCOMING NB. § 6 Term The TRANSFER AGREEMENT terminates automatically in all cases where the existing (original) IVDR formal application lodged at outgoing NB and/or the written agreement concluded with outgoing NB does not comply with the legal and regulatory requirements as specified in IVDR, Art. 110. In such cases, conformity assessment activities will cease and a new IVDR formal application would be required to be submitted by the APPLICANT. The TRANSFER AGREEMENT terminates automatically in all cases where a legacy device no longer complies with the legal and regulatory requirements as specified in IVDR, Art. 110. In such cases the appropriate surveillance by INCOMING NB shall not take place any longer and, if applicable, any accompanying Confirmation Letter shall automatically and to the extent affected hereby cease to be valid. All transferred information and documents may stay with the INCOMING NB for retention purposes. § 7 Miscellaneous 1. (Severability). Should any individual provision of this Agreement or any part of any provision be or become void and/or unenforceable, the validity of the other provisions of this Agreement shall in no way be affected. In such cases, the CERTIFICATION HOLDER/APPLICANT, OUTGOING NB and INCOMING NB shall replace, by way of an amendment or change to this Agreement, the void and/or unenforceable provisions with permissible provisions that fulfil the original intent of the void and/or unenforceable provision to the closest possible extent. The European Association of Medical devices Notified Bodies Team-NB Position Paper TEAM-NB Team-NB-PositionPaper-IVDR-Application-and-appropriate-surveillance-Transfer- agreement-V1-20260610.docx Page 11/13 2. (Written form). Any amendments or changes to this Agreement shall be made in writing. This applies especially to any change to an agreed TRANSFER DATE, which shall be agreed-upon in writing, by way of an addendum to this Agreement, between the involved parties prior to the respective previously agreed TRANSFER DATE. The form provided in Appendix 3 should be used for such addendum. 3. (Liability). Each party is liable for the part of its contractual and legal duties in accordance with the following provisions. INCOMING NB shall assume full responsibility for contracted IVDR conformity assessment activities and, where applicable, appropriate surveillance activities for legacy devices, including the assessment of the CERTIFICATION HOLDER’s vigilance system with respect to all devices included in the scope of certification subject to transferred surveillance. However, according to IVDR, Art. 110 (3e), subparagraph 3, the INCOMING NB shall not be responsible for conformity assessment activities including previous surveillance activities carried out by OUTGOING NB as the notified body that issued the IVDD certificate(s) before the TRANSFER DATE. The liability does not apply where the OUTGOING NB has intentionally or through gross negligence concealed incomplete or incorrect performance of any of its duties or obligations. OUTGOING NB shall assume full responsibility for the certification subject to transferred surveillance, including all conformity assessment activities and previous surveillance activities prior to TRANSFER DATE. In particular, the OUTGOING NB recognises its responsibility for any act or omission accomplished prior to TRANSFER DATE. The CERTIFICATION HOLDER commits not to hold the INCOMING NB responsible for these acts or omissions. 4. (Applicable Law, Jurisdiction). Unless otherwise agreed, this Agreement shall be governed by, and interpreted in accordance with the substantive laws of the country of INCOMING NB exclusive of any rules with respect to conflicts of laws. 5. (Disputes). Disputes arising in connection with this Agreement shall be settled as follows: a. Disputes between CERTIFICATION HOLDER/APPLICANT and INCOMING NB shall be settled by CERTIFICATION HOLDER/APPLICANT and INCOMING NB under the provisions of their certification agreement. b. Disputes between CERTIFICATION HOLDER/APPLICANT and OUTGOING NB shall be settled by CERTIFICATION HOLDER/APPLICANT and OUTGOING NB under the provisions with regard to appeals of their certification agreement. The European Association of Medical devices Notified Bodies Team-NB Position Paper TEAM-NB Team-NB-PositionPaper-IVDR-Application-and-appropriate-surveillance-Transfer- agreement-V1-20260610.docx Page 12/13 c. Disputes between INCOMING NB and OUTGOING NB, or disputes between all the parties, CERTIFICATION HOLDER/APPLICANT, INCOMING NB, and OUTGOING NB, shall be governed by, and interpreted in accordance with the substantive laws of country of INCOMING NB exclusive of any roles with respect to conflicts of laws. 6. (Coming into force) This Agreement comes into force on the date the last of the involved parties, INCOMING NB, OUTGOING NB7, and CERTIFICATION HOLDER and APPLICANT (where different than the certification holder) has signed this Agreement. 7. (Ends) This Agreement ends automatically in all cases where the IVDR application subject to transfer is refused, withdrawn or otherwise invalidated prior to TRANSFER DATE, or the assessment prior to transfer by the INCOMING NB is not completed successfully (e.g., in case of unresolved issues). Under all such circumstances, all transferred information, and documents may remain with the INCOMING NB for archiving purposes. § 8 Agreement conclusion and amendments The transfer(s) of the IVDR formal application and, where applicable, of appropriate surveillance of legacy devices in accordance with this Agreement shall be accomplished in the following steps: 1. (Step 1). This Agreement shall be filled in and signed at first by CERTIFICATION HOLDER and APPLICANT (where different than the certification holder), then by INCOMING NB. The APPLICANT forwards the Agreement to the OUTGOING NB. The Agreement shall be signed at last by OUTGOING NB who forwards it to both CERTIFICATION HOLDER/APPLICANT and INCOMING NB. The Parties shall clarify the content of Appendix 1, and, if applicable, of Appendix 2 between each other. 2. (Step 2). In case the exact TRANSFER DATE has not yet been specified, as soon as the INCOMING NB’s activities have progressed sufficiently in order to specify the TRANSFER DATE and any other information in Appendix 1 and, if applicable, Appendix 2, or if it becomes clear that any of this information is no longer correct, the information in Appendix 1, and, if applicable, in Appendix 2 must be supplemented or updated by way of an addendum to this Agreement. The form provided in Appendix 3 should be used for such an addendum, and the signatures may be performed as described in Step 1. If the involvement of the OUTGOING NB in this Agreement is not practicable7, the Agreement shall be considered valid with the signatures of the CERTIFICATION HOLDER/APPLICANT and of the INCOMING NB. In these cases, the obligations of the OUTGOING NB in accordance with this 7 Where practicable, as per IVDR article 53. Where practicable considering cases where the OUTGOING NB could be unable to sign this transfer agreement, e.g. termination of business. The European Association of Medical devices Notified Bodies Team-NB Position Paper TEAM-NB Team-NB-PositionPaper-IVDR-Application-and-appropriate-surveillance-Transfer- agreement-V1-20260610.docx Page 13/13 Agreement should be fulfilled by CERTIFICATION HOLDER/APPLICANT as far as possible. In this case, it is the responsibility of the INCOMING NB to decide whether the transfer of IVDR application and, if applicable, of appropriate surveillance of related legacy devices, is appropriate, what additional assessment activities are needed prior to assuming the responsibility, and whether there are sufficient elements to maintain the appropriate surveillance in the way to keep the certification valid in the meaning of § 2.2 (1) of this Agreement. The parties confirm that information provided in this Agreement and its Appendix 1, and if applicable Appendix 2, is correct and up-to-date to their best knowledge. Agreed on behalf of the IVDR APPLICANT <place, date> ……………………………………………… <name> <position> Agreed on behalf of the IVDD CERTIFICATION HOLDER <place, date> ……………………………………………… <name> <position> OR ☐ N.A., same as IVDR APPLICANT ☐ N.A., not subject to transfer of appropriate surveillance Agreed on behalf of INCOMING NB: <place, date> ……………………………………………… <name> <position> Agreed on behalf of OUTGOING NB: <place, date> ……………………………………………… <name> <position> Autor Instructions: If there are more than one IVDD legal manufacturers involved, copy and paste the IVDD certification holder signature box as needed. The European Association of Medical devices Notified Bodies Team-NB Position Paper TEAM-NB Team-NB-PositionPaper-IVDR-Application-and-appropriate-surveillance-Transfer- agreement-V1-20260610.docx Page 1/4 Attached: ☒ Appendix 1 – Devices covered by the IVDR formal application subject to transfer and legacy devices subject to transfer of appropriate surveillance, including transfer date (mandatory) ☒ Copies of confirmation letters (where issued) and copies of certificates specified in Appendix 1, with any written confirmations to supplement or correct information mentioned in such certificate that covers the legacy devices subject to transfer of appropriate surveillance (mandatory) ☐ Appendix 2 – Transition provisions (optional) ☐ Appendix 3 – Addendum form to specify or amend Appendices 1 and/or 2 (optional) Overview of provisions covered or taken into consideration in this Agreement: 1. Article 53 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU 2. MDCG 2018-8, “Guidance on content of the certificates, voluntary certificate transfers” 3. Articles 110 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU as amended by Regulation (EU) 2024/1860. 4. MDCG 2022-6, “Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR”. 5. MDCG 2022-15, “Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD”. 6. MDCG 2019-6 Rev.5 Questions and answers: Requirements relating to notified bodies (in particular, sections I.6.3 and IV. 13 with reference to leveraging evidence) 7. European Commission, Q&A on practical aspects related to the implementation of Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices (July 2024) 8. MDCG 2022-8 Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC The European Association of Medical devices Notified Bodies Team-NB Position Paper TEAM-NB Team-NB-PositionPaper-IVDR-Application-and-appropriate-surveillance-Transfer- agreement-V1-20260610.docx Page 2/4 Appendix 1 Devices subject to transfer of the IVDR application and legacy devices subject to transfer of appropriate surveillance Table 1 - Devices covered by this Agreement and for which the IVDR formal application is being transferred to the INCOMING NBxxxx The APPLICANT and the OUTGOING NB declare that the IVDR formal application has been submitted by the relevant deadline and that the IVDR written agreement has been concluded by the relevant deadline. Date when the IVDR formal application has been submitted by the APPLICANT to the OUTGOING NB: DD.MM.YYYY Date when the IVDR written agreement has been concluded by the APPLICANT and the OUTGOING NB: DD.MM.YYYY Name or REF to the device covered by the IVDR formal application Confirmation of status of conformity assessment activities and, where applicable, confirmation that there are no non- compliances with relevant IVDR requirements that are going to lead to a refusal of the applicant's application or to a refusal of the issuance of a certificate List of assessments/ audits conducted pursuant art. 48 IVDR by the outgoing NB and associated reports references OR issued IVDR certificate reference(s) (Certificate # incl. Rev.) Agreed TRANSFER DATE (§ 1 (2)) OR reference to the IVDR certificate transfer agreement IVDR Device name Intended to substitute legacy device: State legacy device name or ☐ Not applicable ☐Conformity assessment activities have not yet been conducted as per Article 48 IVDR for the device. OR ☐ Conformity assessment activities have been conducted as per Article 48 IVDR for the device (provide the relevant assessment reports or findings to the INCOMING NB). AND ☐ There are no non-compliances with relevant IVDR requirements that are going to lead to a refusal of the application or to a refusal of the issuance of a certificate OR ☐ There are non-compliances with relevant IVDR requirements that are going to lead to a refusal of the application or to a refusal of the issuance of a certificate. The transfer of IVDR application CANNOT proceed for this device. OR ☐ IVDR certificate(s) already issued covering this device (a separate transfer of IVDR certification must be signed between INCOMING NB, OUTGOING NB and APPLICANT as per Article 53 IVDR). ☐ Transfer date: DD.MM.YYYY OR ☐ IVDR certificate issued and under a dedicated transfer agreement IVDR Device name ☐Conformity assessment activities have not yet been conducted as per Article 48 IVDR for the device. ☐ Transfer date: DD.MM.YYYY The European Association of Medical devices Notified Bodies Team-NB Position Paper TEAM-NB Team-NB-PositionPaper-IVDR-Application-and-appropriate-surveillance-Transfer- agreement-V1-20260610.docx Page 3/4 Intended to substitute legacy device: State legacy device name or ☐ Not applicable OR ☐ Conformity assessment activities have been conducted as per Article 48 IVDR for the device (provide the relevant assessment reports or findings to the INCOMING NB). AND ☐ There are no non-compliances with relevant IVDR requirements that are going to lead to a refusal of the application or to a refusal of the issuance of a certificate OR ☐ There are non-compliances with relevant IVDR requirements that are going to lead to a refusal of the application or to a refusal of the issuance of a certificate. The transfer of IVDR application CANNOT proceed for this device. OR ☐ IVDR certificate(s) already issued covering this device (a separate transfer of IVDR certification must be signed between INCOMING NB, OUTGOING NB and APPLICANT as per Article 53 IVDR). OR ☐ IVDR certificate issued and under a dedicated transfer agreement Table 2 - Devices covered by this Agreement and for which the INCOMING NBxxxx will become responsible for the appropriate surveillance under the applicable Directive as of the transfer date The agreed transfer date for the transfer of appropriate surveillance for a legacy device is the same transfer date identified in table 1 for the corresponding IVDR device or IVDR substitute device. IVDD Device name or REF IVDD Certificate Reference(s) of the IVDD device Is the device under IVDD replaced (substituted) with another device under IVDR – please identify the corresponding substitute device under IVDR application Maximum Transition timeline as per in Article 110 (3c) of IVDR (as amended by EU 2024/1860) Imposed restrictions on the valid and not- suspended (IVDD certificate or other relevant information The last serial number or lot number for which the outgoing notified body is responsible (see § 2.2 (5)) Device 1 Certificate # incl. Rev. ☐ N/A or ☐ Identification of the corresponding IVDR substitute device ☐ 31 December 2027 Device 2 Certificate # incl. Rev. ☐ N/A or ☐ Identification of the corresponding ☐ 31 December 2027 The European Association of Medical devices Notified Bodies Team-NB Position Paper TEAM-NB Team-NB-PositionPaper-IVDR-Application-and-appropriate-surveillance-Transfer- agreement-V1-20260610.docx Page 4/4 IVDR substitute device The European Association of Medical devices Notified Bodies Team-NB Position Paper TEAM-NB Team-NB-PositionPaper-IVDR-Application-and-appropriate-surveillance-Transfer- agreement-V1-20260610.docx Page 1/1 Appendix 2 – Transition provisions Optional Note: If there is no change in NB number with the transfer of appropriate surveillance, then this Appendix shall be deleted/struck through or use “not applicable” check box. ☐ Not applicable Traceability table: Identification number of the OUTGOING NB to the identification number of the INCOMING NB The parties have agreed that the NB number will change from XXXX to XXXX upon the transfer of appropriate surveillance. Legacy device subject to transfer of appropriate surveillance [IVDD Device name or REF. as in Appendix 1] The last serial number or lot number for which the OUTGOING NB is responsible and for which the identification number of the OUTGOING NB is applied (see § 2.2 (5)) Agreed SELL-OFF PERIOD (see § 2.2 (5)) If not explicitly specified, the SELL-OFF PERIOD is xx months from the TRANSFER DATE. ☐ Not yet available ☐ Not explicitly specified ☐ Not yet available ☐ Not explicitly specified ☐ Not yet available ☐ Not explicitly specified The European Association of Medical devices Notified Bodies Team-NB Position Paper TEAM-NB Team-NB-PositionPaper-IVDR-Application-and-appropriate-surveillance-Transfer- agreement-V1-20260610.docx Page 1/5 Optional Appendix 3 – Addendum form to specify or amend Appendices 1 and/or 2 ADDENDUM No. <x> to the TRANSFER AGREEMENT coming into force on <date> between The company (legal manufacturer that submitted a IVDR formal application for conformity assessment activities to the OUTGOING NB) <customer name> <customer address> - hereinafter referred to as “APPLICANT” , The company (legal manufacturer of the legacy devices subject to transfer of appropriate surveillance) ☐ N.A., no appropriate surveillance to be transferred or ☐ Same as “APPLICANT” or <customer name> <customer address> - hereinafter referred to as “CERTIFICATION HOLDER” , Autor Instructions: In case the IVDR legal manufacturer and the IVDD legal manufacturer are different, the transfer can happen only if the legal manufacturer under IVDR formal application and written agreement and the legal manufacturer holding the IVDD certificate are part of the same large organisation (refer to Q&A on practical aspects related to the implementation of Regulation (EU) 2024/1860, question 7.2). If there are more than one IVDD legal manufacturers involved, copy and paste this section as needed. Autor Tick if the applicant is the same as the certification holder. If the applicant is different than the certification holder, provide customer name and address. The European Association of Medical devices Notified Bodies Team-NB Position Paper TEAM-NB Team-NB-PositionPaper-IVDR-Application-and-appropriate-surveillance-Transfer- agreement-V1-20260610.docx Page 2/5 The notified body with the identification number: <XXXX> <Incoming NB name> <Incoming NB address> - hereinafter referred to as “INCOMING NB” -, and The notified body with the identification number: <XXXX> <Outgoing NB name> <Outgoing NB address> - hereinafter referred to as “OUTGOING NB” - The parties have agreed to amend the above-mentioned Agreement as follows in accordance with § 7 (2) and/or § 8 (2): 1. The tables in Appendix 1 (Devices subject to transfer of the IVDR application and legacy devices subject to transfer of appropriate surveillance) are replaced with the following tables: Table 1 - Devices covered by this Agreement and for which the IVDR formal application is being transferred to the INCOMING NBxxxx The APPLICANT and the OUTGOING NB declare that the IVDR formal application has been submitted by the relevant deadline and that the IVDR written agreement has been concluded by the relevant deadline. Date when the IVDR formal application has been submitted by the APPLICANT to the OUTGOING NB: DD.MM.YYYY Date when the IVDR written agreement has been concluded by the APPLICANT and the OUTGOING NB: DD.MM.YYYY Name or REF to the device covered by the IVDR formal application Confirmation of status of conformity assessment activities and, where applicable, confirmation that there are no non- compliances with relevant IVDR requirements that are going to lead to a refusal of the applicant's application or to a refusal of the issuance of a certificate List of assessments/ audits conducted pursuant art. 48 IVDR by the outgoing NB and associated reports references OR issued IVDR certificate reference(s) (Certificate # incl. Rev.) Agreed TRANSFER DATE (§ 1 (2)) OR reference to the IVDR certificate transfer agreement IVDR Device name ☐Conformity assessment activities have not yet been conducted as per Article 48 IVDR for the device. OR ☐ Transfer date: DD.MM.YYYY OR The European Association of Medical devices Notified Bodies Team-NB Position Paper TEAM-NB Team-NB-PositionPaper-IVDR-Application-and-appropriate-surveillance-Transfer- agreement-V1-20260610.docx Page 3/5 Intended to substitute legacy device: State legacy device name or ☐ Not applicable ☐ Conformity assessment activities have been conducted as per Article 48 IVDR for the device (provide the relevant assessment reports or findings to the INCOMING NB). AND ☐ There are no non-compliances with relevant IVDR requirements that are going to lead to a refusal of the application or to a refusal of the issuance of a certificate OR ☐ There are non-compliances with relevant IVDR requirements that are going to lead to a refusal of the application or to a refusal of the issuance of a certificate. The transfer of IVDR application CANNOT proceed for this device. OR ☐ IVDR certificate(s) already issued covering this device (a separate transfer of IVDR certification must be signed between INCOMING NB, OUTGOING NB and APPLICANT as per Article 53 IVDR). ☐ IVDR certificate issued and under a dedicated transfer agreement IVDR Device name Intended to substitute legacy device: State legacy device name or ☐ Not applicable ☐Conformity assessment activities have not yet been conducted as per Article 48 IVDR for the device. OR ☐ Conformity assessment activities have been conducted as per Article 48 IVDR for the device (provide the relevant assessment reports or findings to the INCOMING NB). AND ☐ There are no non-compliances with relevant IVDR requirements that are going to lead to a refusal of the application or to a refusal of the issuance of a certificate OR ☐ There are non-compliances with relevant IVDR requirements that are going to lead to a refusal of the application or to a refusal of the issuance of a certificate. The transfer of IVDR application CANNOT proceed for this device. OR ☐ IVDR certificate(s) already issued covering this device (a separate transfer of IVDR certification must be signed between INCOMING NB, OUTGOING NB and APPLICANT as per Article 53 IVDR). ☐ Transfer date: DD.MM.YYYY OR ☐ IVDR certificate issued and under a dedicated transfer agreement Table 2 - Devices covered by this Agreement and for which the INCOMING NBxxxx will become responsible for the appropriate surveillance under the applicable Directive as of the transfer date The agreed transfer date for the transfer of appropriate surveillance for a legacy device is the same transfer date identified in table 1 for the corresponding IVDR device or IVDR substitute device. The European Association of Medical devices Notified Bodies Team-NB Position Paper TEAM-NB Team-NB-PositionPaper-IVDR-Application-and-appropriate-surveillance-Transfer- agreement-V1-20260610.docx Page 4/5 IVDD Device name or REF IVDD Certificate Reference(s) of the IVDD device Is the device under (AI)MDD replaced (substituted) with another device under IVDR – please identify the corresponding substitute device under IVDR application Maximum Transition timeline as per in Article 110 (3c) of IVDR (as amended by EU 2024/1860) Imposed restrictions on the valid and not- suspended (AI)MDD certificate or other relevant information The last serial number or lot number for which the outgoing notified body is responsible (see § 2.2 (5)) Device 1 Certificate # incl. Rev. ☐ N/A or ☐ Identification of the corresponding IVDR substitute device ☐ 31 December 2027 Device 2 Certificate # incl. Rev. ☐ N/A or ☐ Identification of the corresponding IVDR substitute device ☐ 31 December 2027 2. The table in Appendix 2 (Transition provisions) is replaced with the following table: Legacy device subject to transfer of appropriate surveillance [IVDD Device name or REF. as in Appendix 1] The last serial number or lot number for which the OUTGOING NB is responsible and for which the identification number of the OUTGOING NB is applied (see § 2.2 (5)) Agreed SELL-OFF PERIOD (see § 2.2 (5)) If not explicitly specified, the SELL-OFF PERIOD is xx months from the TRANSFER DATE. ☐ Not yet available ☐ Not explicitly specified ☐ Not yet available ☐ Not explicitly specified ☐ Not yet available ☐ Not explicitly specified The European Association of Medical devices Notified Bodies Team-NB Position Paper TEAM-NB Team-NB-PositionPaper-IVDR-Application-and-appropriate-surveillance-Transfer- agreement-V1-20260610.docx Page 5/5 The parties confirm that information provided in this Agreement and its Appendix 1, and if applicable Appendix 2, is correct and up-to-date to their best knowledge. Agreed on behalf of the IVDR APPLICANT <place, date> ……………………………………………… <name> <position> Agreed on behalf of the MDD/AIMDD CERTIFICATION HOLDER <place, date> ……………………………………………… <name> <position> OR ☐ N.A., same as IVDR APPLICANT ☐ N.A., not subject to transfer of appropriate surveillance Agreed on behalf of INCOMING NB: <place, date> ……………………………………………… <name> <position> Agreed on behalf of OUTGOING NB: <place, date> ……………………………………………… <name> <position> Autor Instructions: If there are more than one IVDD legal manufacturers involved, copy and paste the IVDD certification holder signature box as needed. If there are more than one outgoing NBs involved, copy and paste the outgoing NB signature box as needed. The European Association of Medical devices Notified Bodies Team-NB Position Paper TEAM-NB Team-NB-PositionPaper-IVDR-Application-and-appropriate-surveillance-Transfer- agreement-V1-20260610.docx Page 1/2 Optional information Checklist of minimum documents to be submitted to the INCOMING NB by Manufacturer or OUTGOING NB: Transfer of the IVDR formal application • Copies of confirmation letters (if issued) • Audit reports including their findings lists covering all IVDR formal applications being “transferred” (all reports for current certification cycle, including unannounced audit), if applicable • Technical documentation assessment report(s), and/or list of finding(s) from the assessment, if applicable • Consultation reports by authorities • List of open / still pending non-conformities and their grading (minor/major) and related plan of corrections and corrective / preventative actions • Pending appeals • For Class Ds, Performance Verification report (EURLs) and/or batch testing criteria (if already performed/set/ongoing). Transfer of appropriate surveillance for legacy devices • Copies of certificate specified in Appendix 1, with any written confirmations to supplement or correct information mentioned in such certificate that covers the legacy devices subject to transfer of appropriate surveillance • Detailed list(s) of device(s) covered by the certificate • List of conditions correlated to the certificate(s) • Prior audit reports incl. their findings lists – time frame at least current certification cycle • IVDD full technical documentation(s) of legacy device(s) and the latest related assessment report issued by OUTGOING NB - time frame minimum current certification cycle • Consultation reports by authorities • List of vigilance cases – time frame at least current certification cycle • List of open / still pending non-conformities and their grading (minor/major) and related plan of corrections and corrective / preventative actions • List of ongoing change notifications being assessed • Pending appeals • For Annex II List A devices, copies of the final QC release testing for the last three batches performed by the Manufacturer and/or the Certificate of Analysis for that batch performed by the Manufacturer and the relevant labelling for verification • Reports on the verification of manufactured products covered by Annex II, List A for which physical verification of manufactured products was conducted (last three batches, if available) The European Association of Medical devices Notified Bodies Team-NB Position Paper TEAM-NB Team-NB-PositionPaper-IVDR-Application-and-appropriate-surveillance-Transfer- agreement-V1-20260610.docx Page 2/2 Additionally, the OUTGOING NB provides the following to the INCOMING NB directly: Transfer of the IVDR formal application • Sampling plan(s) of the current cycle, if established • Open items to be followed-up, surveillance notes • Audit program of the current cycle, if established Transfer of appropriate surveillance for legacy devices • Sampling plan(s) of the current cycle • Open items to be followed-up, surveillance notes • Audit program of the current cycle • For Annex II List A devices, Notified Body Annex IV section 6 release notices and supporting documentation (e.g Testing laboratory reports) of the last three batches Version 1 10/06/2026 Editor : Team-NB AGREEMENT RELATED TO THE TRANSFER OF IVDR FORMAL APPLICATION AND OF APPROPRIATE SURVEILLANCE OF LEGACY DEVICES specifying the terms of the transfer of Article 110 (3e) application(s) with, where applicable, the transfer of the appropriate surveillance activities according to Article 110 (3e) of Regulation (EU) 2017/746 in respect of legacy devices covered by a certificate issued in accordance with Directive 98/79/EC § 1 AGREEMENT RELATED TO THE TRANSFER OF THE IVDR FORMAL APPLICATION § 1.1 Scope § 1.2 Validity of the IVDR formal application subject to transfer § 2 Transfer of the appropriate surveillance activities according to Article 110 (3e) of Regulation (EU) 2017/746 § 2.1 Scope § 2.2 Validity of certification and notified body appropriate surveillance activities for the legacy devices subject to transfer of appropriate surveillance § 2.3 Continued appropriate surveillance § 3 Assessment prior to transfer § 4 Confidentiality and obligation to provide information § 5 Settlement and property rights § 6 Term § 7 Miscellaneous § 8 Agreement conclusion and amendments Appendix 1 Table 1 - Devices covered by this Agreement and for which the IVDR formal application is being transferred to the INCOMING NBxxxx Table 2 - Devices covered by this Agreement and for which the INCOMING NBxxxx will become responsible for the appropriate surveillance under the applicable Directive as of the transfer date Appendix 2 – Transition provisions Appendix 3 – Addendum form to specify or amend Appendices 1 and/or 2 Table 1 - Devices covered by this Agreement and for which the IVDR formal application is being transferred to the INCOMING NBxxxx Table 2 - Devices covered by this Agreement and for which the INCOMING NBxxxx will become responsible for the appropriate surveillance under the applicable Directive as of the transfer date Checklist of minimum documents to be submitted to the INCOMING NB by Manufacturer or OUTGOING NB:

Gemäß Artikel 110 Absatz 3e der Verordnung (EU) 2017/746 über In-vitro-Diagnostika (IVDR) sind die Modalitäten zur Übertragung der angemessenen Überwachung von Bestandsprodukten in einer Vereinbarung festzulegen. Diese ist zwischen dem Hersteller und der Benannten Stelle zu schließen, bei der ein förmlicher Antrag gestellt wurde, sowie soweit praktikabel mit der Benannten Stelle, die die IVDD-Bescheinigung ausgestellt hat. Wird der Antrag auf Konformitätsbewertung nach Ablauf der einschlägigen Fristen zurückgezogen oder die schriftliche Vereinbarung gekündigt, gelten die Voraussetzungen nach Artikel 110 Absatz 3c Buchstaben e und f IVDR als nicht mehr erfüllt. In diesen Fällen endet die Anwendbarkeit der Übergangsfrist. Anders verhält es sich, wenn im Zuge der Kündigung gleichzeitig eine neue Vereinbarung mit einer anderen Benannten Stelle geschlossen und der Antrag entsprechend übertragen wird. In diesem Fall bleiben die Voraussetzungen weiterhin erfüllt, sodass die Übergangsfrist fortbesteht vorausgesetzt, auch die übrigen Bedingungen sind eingehalten. Die konkreten Modalitäten für den Wechsel der Benannten Stelle sollen dabei in einer Vereinbarung zwischen Hersteller, bisheriger und neuer Benannter Stelle im Einklang mit den Grundsätzen des Artikels 53 IVDR geregelt werden. Vor diesem Hintergrund hat Team-NB am 10. Juni 2026 ein Positionspapier veröffentlicht, das eine Mustervereinbarung für die Übertragung des formellen IVDR-Antrags sowie für die Organisation der angemessenen Überwachung von Bestandsprodukten bereitstellt. Das Positionspapier berücksichtigt die Fragen und Antworten der Europäischen Kommission zu praktischen Aspekten der Anwendung der Verordnung (EU) 2023/607 zur Änderung der Verordnungen (EU) 2017/745 und (EU) 2017/746 hinsichtlich der Übergangsbestimmungen für bestimmte Medizinprodukte und In-vitro-Diagnostika (siehe Teil C, Frage 7.1).

IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red © 2026. All rights reserved. IQVIA® is a registered trademark of IQVIA Inc. in the United States, the European Union, and various other countries. Entwicklung des deutschen Pharmamarktes im 1. Quartal 2026 IQVIA MARKTBERICHT - Grafiken - IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red 1 Der IQVIA Marktbericht informiert über aktuelle Entwicklungen im deutschen Arzneimittelmarkt. Der Bericht enthält Analysen über den Pharmagesamtmarkt, den Klinik- und Apothekenmarkt sowie den GKV-Markt. IQVIAs Marktbericht basiert ab sofort auf der neuen IQVIA Data Integration Platform (DIP)! Die Prozessierung über die neue DIP-Plattform bietet eine noch präzisere Informationsaufbereitung der auf Apothekenrechenzentren basierenden Rx-Daten durch innovative Verbesserungen mit hoher Business-Relevanz. © 2026, IQVIA Commercial GmbH & Co. OHG. All rights reserved. – IQVIA Marktbericht | im 1. Quartal 2026 IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red 2 IQVIAs Data Integration Platform Noch präzisere Marktanalysen – smartere Entscheidungen Optimierte Basis für Ihre Business Intelligence Genauere Darstellung der GKV-Rezepte Optimierte PKV-/Bar-Hochrechnung Erweitertes Apothekenpanel Verbesserte Datenkonsistenz © 2026, IQVIA Commercial GmbH & Co. OHG. All rights reserved. – IQVIA Marktbericht | im 1. Quartal 2026 IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red 3 Inhaltsverzeichnis • Zusammenfassung • Summary • Entwicklung im Pharma-Gesamtmarkt (Apotheke und Klinik) • Entwicklung im Klinikmarkt • Entwicklung im Apothekenmarkt • Entwicklung im OTC-Apotheken- versandhandel und bei rezeptfreien Arznei- und Nichtarzneimitteln • Entwicklung im GKV-Markt • Kalendereffekte zur Marktbetrachtung im Jahr • Datenquellen • Erläuterungen zu den Auswertungen • Impressum IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red 4 • Die monatliche Entwicklung des Klinik- und Apothekenmarktes zeigt im ersten Quartal 2026 eine insgesamt positive Dynamik. • Im 1. Quartal 2026 steigt der Umsatz mit Arzneimitteln im gesamten Pharmamarkt (Apotheke und Klinik) um 4,6 %. Der Absatz ist leicht rückläufig (-1,2 %). Es wurden in den ersten drei Monaten dieses Jahres 25,2 Mrd. Zähleinheiten (ZE; z.B. Kapseln, Hübe, Portionsbeutel etc.) im Wert von 17,3 Mrd. Euro an Patientinnen und Patienten abgegeben. • Zur Monatsentwicklung: In den ersten beiden Monaten des Jahres verlief die Umsatzentwicklung im Kliniksegment weitgehend stagnierend, bevor es im März zu einer Belebung kam (Umsatzwachstum von knapp +7 % vs. VJ). Ein ähnliches Muster zeigt sich beim Absatz im Klinikmarkt mit zunächst stärker rückläufigen Absatzentwicklungen im Januar und Februar, gefolgt von einer positiven Dynamik im März von fast +6 %. Auch im Apothekenmarkt liegen die Absatzveränderungsraten in den ersten beiden Monaten im negativen Bereich. Die Umsatzveränderung entwickelt sich hingegen positiv und beschleunigte im Verlauf der ersten drei Monate von einer zunächst schwachen Wachstumsrate bis zu dem höchsten Zuwachs im März von +11,3 % gegenüber Vorjahresmonat. • Insgesamt verzeichnete der Apothekenmarkt im ersten Quartal 2026 ein Umsatzwachstum von +4,8 % im Vgl. mit Q1/2025 auf 14,8 Mrd. Euro. Es wurden 426,7 Mio. Packungen an Patientinnen und Patienten abgegeben, was einer rückläufigen Absatzentwicklung von -4 % vs. Vorjahreszeitraum entspricht. • Die GKV-Arzneimittelausgaben steigen im Vergleich zum Vorjahreszeitraum Q1/2025 um +3,6 % auf 15 Mrd. Euro. Die Absatzveränderung nach Packungen fällt in dieser Marktbetrachtung um -2,8 % auf 183,3 Millionen. • Im Klinikmarkt entfallen im ersten Quartal 2026 rund 62,3 % des Gesamtumsatzes im stationären Sektor auf die zehn umsatzstärksten Arzneimittelgruppen (ca. 1,55 Mrd. Euro). Drei der zehn Gruppen weisen zweistellige Umsatzzuwachsraten auf; den stärksten Zuwachs von +21,6 % vs. VJ verzeichnet die Gruppe L04X (Sonstige Immunsuppressiva), die vor allem bei hochspezialisierten Immuntherapien Anwendung findet. Bei den mengenstärksten Arzneimittelgruppen im Klinikmarkt zeigt sich ein uneinheitliches Bild im 1. Quartal: Fünf der zehn absatzstärksten Gruppen verzeichnen rückläufige Veränderungsraten. Zusammenfassung: Pharma-Gesamtmarkt (Apotheke u. Klinik) © 2026, IQVIA Commercial GmbH & Co. OHG. All rights reserved. – IQVIA Marktbericht | im 1. Quartal 2026 IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red 5 • Der Apothekenmarkt verzeichnet im ersten Quartal 2026 ein Umsatzwachstum von +4,8 % gegenüber dem Vorjahreszeitraum. Der Absatz ist im gleichen Zeitraum rückläufig (-4,1 %). Insgesamt wurden 426,7 Mio. Packungen im Wert von 14,8 Mrd. Euro (zum Abgabepreis des pharmazeutischen Unternehmers, inkl. Impfstoffe und Testdiagnostika) an Patientinnen und Patienten abgegeben. • Die Monatsentwicklung zeigt eine zunehmende Dynamik: Die Umsatzverände- rungsraten steigen von zunächst unter einem Prozent zu Jahresbeginn auf rund +11 % im März. Die rückläufige Absatzentwicklung schwächt sich im Quartals- verlauf ab von etwa -7 % auf nahezu stabile Werte im März (knapp unter 1 %). • Das Segment der rezeptpflichtigen Präparate aus dem Apothekenmarkt wächst im Q1 2026 nach Umsatz um knapp +6 % vs. VJ, während der Absatz weiter leicht rückläufig verbleibt (-1,3 %). Dies entspricht einem Marktvolumen von rund 13,1 Mrd. Euro sowie 199,5 Mio. abgegebenen Packungen. Wachstumstreiber sind insbesondere patentgeschützte Produkte. Auch Biosimilars verzeichnen im Apothekenmarkt ein deutliches Absatzwachstum von +15,6 %. • Im Segment der rezeptfreien Arzneimittel wurden in den ersten drei Monaten 2026 insgesamt 227,2 Mio. Packungen im Apothekenmarkt abgegeben (-6,5 % gegenüber Vorjahreszeitraum). Auch der Umsatz ist rückläufig und sank um -2,7 % auf 1,7 Mrd. Euro. • Die Entwicklung der rezeptfreien Arznei- und Gesundheitsmittel betrachtet nach Rezepttyp und Selbstmedikation zeigt eine differenzierte Dynamik: Die GKV-Verordnungen verzeichnen mit +1,4 % den höchsten Zuwachs. Dagegen sind die Empfehlungen über das Grüne Rezept sowie PKV-Verordnungen in Summe um -3 % rückläufig. Es ist zu berücksichtigen, dass diese beiden Rezept- arten in manchen Apothekensystemen nicht immer eindeutig getrennt erfasst werden und das „Grüne Rezept“ mitunter als „Privat-Rezept“ verbucht wird. Die Selbstmedikation, die den Löwenanteil in dieser Marktbetrachtung auf sich vereint, zeigt eine stabile bis leicht rückläufige Umsatzentwicklung und einen um -3,4 % gesunkenen Absatz im ersten Quartal. • Der Versandhandelsmarkt der rezeptfreien Arznei- und Nichtarzneimittel legt im ersten Quartal 2026 nach Wert um knapp 9 % zu (966 Mio. Euro). Die abgesetzte Menge steigt um +7,2 % auf 73 Mio. Packungen. Bei den absatz- stärksten Arznei- und Gesundheitsmittelgruppen im Versandhandel wachsen Augenpräparate mit rund +17 % am stärksten, gefolgt von der Gruppe der Vitamine, Mineralstoffe und Nahrungsergänzungen (+14,4 %). Die Erkältungs- mittel inkl. Husten- und Atemwegspräparate legen um moderate + 5 % zu. Zusammenfassung: Apothekenmarkt © 2026, IQVIA Commercial GmbH & Co. OHG. All rights reserved. – IQVIA Marktbericht | im 1. Quartal 2026 HINWEISE: Die Basis der hier dargestellten Umsatzwerte bildet, soweit nicht anders vermerkt, der Abgabepreis des pharmazeutischen Unternehmers abzüglich des Herstellerabschlages und der gemeldeten Rabatte aus Erstattungsbeträgen nach §130b SGB V. Je nach Marktsegment und betrachtetem Zeitraum sind hierbei verschiedene Abschlagssätze gültig (6 %, 7 %, 12 %). Einsparungen aus Rabattverträgen nach §130a Abs. 8 SGB V sind nicht berücksichtigt. Das „Grüne Rezept“ und „Privat-Rezept“ werden in Summe ausgewiesen, da die Verbuchung in manchen Apothekensystemen nicht immer differenziert erfolgt. So wird das „Grüne Rezept“ mitunter auch als „Privat-Rezept“ interpretiert und verbucht. IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red 6 • Die GKV-Arzneimittelausgaben abzüglich der Abschläge von Herstellern (§ 130a Abs. 1 SGB V) und Apotheken (ohne Berücksichtigung von Einsparungen aus Rabattverträgen) belaufen sich im ersten Quartal 2026 auf 15,0 Mrd. Euro. Das entspricht einem Anstieg von +3,6 % gegenüber Vorjahreszeitraum. • Der Absatz beträgt im gleichen Zeitraum 183,25 Mio. abgegebene Packungen und liegt damit um –2,8 % unter dem Vorjahresniveau. • Innerhalb der zehn umsatzstärksten Arzneimittelgruppen im GKV-Markt der ersten drei Monate 2026 verzeichnet die Gruppe der GLP-1 Agonisten (Antidiabetika) weiterhin die höchsten Zuwächse mit +30,2 %. Weitere zweistellige Zuwachsraten nach Umsatz zeigen Interleukin Inhibitoren (+18 %) und SGLT2-Hemmer (Antidiabetika; +13 %). Moderate Zuwächse im oberen einstelligen Bereich weist die Gruppe der Proteinkinase-Hemmer (antineoplastische und immunmodulierende Mittel; +8,6 %) auf. Bei den zehn absatzstärksten Produktgruppen im GKV-Markt weisen Lipidregulatoren und reine Calciumantagonisten die höchsten Zuwächse mit jeweils rund +7 % nach Wert auf. • Die Einsparungen der gesetzlichen Krankenversicherung durch Herstellerzwangsabschläge und Rabatte aus Erstattungsbeträgen belaufen sich in den ersten drei Monaten des Jahres 2026 auf 2,869 Mrd. Euro (+11 %). • Auch für die privaten Krankenversicherungen steigen die Einsparungen durch Herstellerzwangsabschläge und Rabatte aus Erstattungsbeträgen. Dieses berechnete Volumen beläuft sich im ersten Quartal 2026 auf 442 Mio. Euro* (+14 %). • Im Krankenhaus steigen die Herstellerzwangsabschläge und Rabatte um +3 % auf 70 Mio. Euro. Zusammenfassung: GKV-Markt © 2026, IQVIA Commercial GmbH & Co. OHG. All rights reserved. – IQVIA Marktbericht | im 1. Quartal 2026 Hinweis: Die Basis der hier dargestellten Umsatzwerte bildet der Apothekenverkaufspreis abzüglich des Herstellerabschlages und der gemeldeten Rabatte aus Erstattungsbeträgen nach §130b SGB V sowie der Apothekennachlässe. Je nach Marktsegment und betrachtetem Zeitraum sind hierbei verschiedene Abschlagssätze gültig (6 %, 7 %, 12 %). Einsparungen aus Rabattverträgen § 130a Abs. 8 SGB V sind nicht berücksichtigt. * Berechnetes Einsparvolumen ohne Berücksichtigung von späteren Einreichungen, Beihilfeleistungen etc. IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red 7 • The monthly development of the hospital and pharmacy markets in the first quarter of 2026 shows an overall positive momentum. • In the first quarter of 2026, pharmaceutical revenues in the total market (pharmacies and hospitals) increased by 4.6 %, while volumes declined slightly (-1.2 %). In total, 25.2 billion standard units (ZE; e.g. capsules, doses, portions etc.) were dispensed to patients in the first three months of the year, corresponding to a market value of EUR 17.3 billion. • Monthly development: In the hospital segment, revenue growth was largely stagnant in the first two months of the year before rebounding in March (revenue growth of approx. +7 % vs prior year). A similar pattern is observed for volumes, with more pronounced decl ines in January and February followed by a recovery in March (approx. +6 %). In the pharmacy segment, volume growth remained negative in the first two months, while revenue growth trends were positive and accelerated over the course of the quarter, peaking at +11.3 % in March year-on-year. • Overall, the pharmacy market recorded revenue growth of +4.8 % vs Q1/2025, reaching EUR 14.8 billion. A total of 426.7 millio n packs were dispensed, corresponding to a volume decline of -4 % vs. prior year. • Statutory health insurance (GKV) pharmaceutical expenditure increased by +3.6 % vs. Q1 2025, reaching EUR 15 billion, while volumes declined by -2.8 % to 183.3 million packs. • In the hospital market, the top ten therapeutic groups accounted for approximately 62.3 % of total revenues in Q1 2026 (around EUR 1.55 billion).Three of these groups achieved double-digit growth rates, with the strongest increase in the L04X class (other immunosuppressants) at +21.6 % vs. prior year, primarily driven by highly specialized immunotherapies. On the volume side, the picture is mixed: five of the ten largest groups recorded declining volumes in the first quarter. Summary: Total Pharmaceutical Market (Pharmacy & Hospital) © 2026, IQVIA Commercial GmbH & Co. OHG. All rights reserved. – IQVIA Marktbericht | im 1. Quartal 2026 IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red 8 • The retail pharmacy market recorded revenue growth of +4.8 % year-on-year in the first quarter of 2026, while volumes declined by -4.1 %. • In total, 426.7 million packs were dispensed, corresponding to a market value of EUR 14.8 billion (at ex-manufacturer prices, including vaccines and diagnostic tests). • Monthly trends indicate increasing momentum: revenue growth accelerated from below 1 % at the beginning of the year to around +11 % in March.At the same time, the volume decline moderated over the course of the quarter, improving from approximately -7 % in the early months to nearly stable levels by March. • The prescription (Rx) segment grew by approximately +6 % in value in Q1 2026 compared to the prior year, while volumes remained slightly negative (-1.3 %).This corresponds to a market size of around EUR 13.1 billion and 199.5 million packs dispensed.Growth was primarily driven by patented products, while biosimilars recorded strong volume growth of +15.6 %. • The over-the-counter (OTC) segment declined both in value and volume. A total of 227.2 million packs were dispensed (-6.5 % year-on-year), while revenues fell by -2.7 % to EUR 1.7 billion. • A differentiated picture emerges when analyzing OTC development by prescrip- tion type and self-medication: Statutory health insurance (GKV) prescriptions recorded the strongest growth (+1.4 %), while private prescriptions and “green prescriptions” declined by approximately -3 %.It should be noted that these prescription types are not always clearly differentiated in pharmacy systems, and “green prescriptions” may partially be recorded as private prescriptions. Selfmedi-cation, which represents the largest share of the OTC market, remained broadly stable but declined slightly in volume (-3.4 %). • The OTC mail-order market continued to expand, with revenue growth of nearly +9 % to EUR 966 million in Q1 2026.Volumes increased by +7.2 % to 73 million packs. Among the largest OTC product groups in mail order, ophthalmological products showed the strongest growth (+17 %), followed by vitamins, minerals and supplements (VMS) (+14.4 %).Cold and respiratory products, including cough treatments, grew more moderately at around +5 %. Summary: Total Retail Market © 2026, IQVIA Commercial GmbH & Co. OHG. All rights reserved. – IQVIA Marktbericht | im 1. Quartal 2026 NOTE: Unless otherwise indicated all Euro sales mentioned on this page are calculated on the basis of ex-manufacturer prices (ApU) less compulsory manu- facturers discounts as well as reported rebates on the ex-manufacturer price negotiated between Pharmaceutical manufacturers and the National Association of SHI Funds on patent protected drugs with approved additional benefit (§130b SGB V). Depending on the market segment and the period under consideration, different discount rates apply (6 %, 7 %, 12 %). Savings from rebate contracts (§130a (8) SGB V) are not included. As of Q1/2025 the “green prescriptions” and “private prescriptions” are reported together, as some pharmacy systems do not always differentiate between them. For example, the “green prescriptions” is sometimes interpreted and recorded as a “private prescription”. IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red 9 • Pharmaceutical expenditure in the statutory health insurance system (GKV), net of statutory manufacturer and pharmacy discounts and excluding rebates from discount contracts, amounted to EUR 15.0 billion in Q1 2026, representing an increase of +3.6 % year-on-year. • Volumes totaled 183.3 million packs, corresponding to a decline of -2.8 % compared to the prior year. • Within the ten highest-revenue therapeutic classes, GLP-1 agonists (antidiabetics) continued to show the strongest growth, increasing by +30.2 % year-on-year. Further double-digit growth was observed for interleukin inhibitors (+18 %) and SGLT2 inhibitors (+13 %). Protein kinase inhibitors (antineoplastic and immunomodulatory agents) also recorded solid growth in the high single-digit range (+8.6 %). • Savings for the statutory health insurance system generated through mandatory manufacturer discounts and rebates from negotiated prices amounted to EUR 2.869 billion in Q1 2026, an increase of +11 %. • Savings in the private health insurance (PKV) segment also increased, reaching EUR 442 million (+14 %). • In the hospital sector, manufacturer discounts and rebates rose by +3 % to approximately EUR 70 million. Summary: Statutory Health Insurance Market (SHI) © 2026, IQVIA Commercial GmbH & Co. OHG. All rights reserved. – IQVIA Marktbericht | im 1. Quartal 2026 NOTE: All Euro sales figures on this page are calculated on the basis of ex-pharmacy prices less compulsory manufacturers discounts and reported rebates on the ex-manufacturer price (ApU) negotiated between pharmaceutical manufacturers and the National Association of SHI Funds on patent protected drugs with approved additional benefit (§130b SGB V), as well as pharmacy discounts. Depending on the market segment and the period under consideration, different discount rates apply (6 %, 7 %, 12 %). Savings from rebate contracts according to §130a (8) SGB V are not included. * Calculated savings not including later claims submissions, benefit payments, the so-called “Beihilfe” (a benefit for medical treatment civil servants are eligible to in Germany), etc. IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red Entwicklung im Pharma-Gesamtmarkt (Apotheke und Klinik) IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red 11 Monatliche Marktentwicklung von 03/2025 bis 03/2026 Pharma-Gesamtmarkt im ersten Quartal 2026: Positive Umsatzveränderung bei leicht rückläufigem Absatz © 2026, IQVIA Commercial GmbH & Co. OHG. All rights reserved. – IQVIA Marktbericht | im 1. Quartal 2026 -10 -5 0 5 10 15 03/25 04/25 05/25 06/25 07/25 08/25 09/25 10/25 11/25 12/25 01/26 02/26 03/26 Absatz (ZE)Umsatz (EUR) Kumuliert Januar - März 2026: Umsatz 17,3 Mrd. Euro (+4,6 %) Absatz 25,2 Mrd. ZE (-1,2 %) 8,8 Mrd. ZE 6,1 Mrd. EUR Ve rä nd er un gs ra te in % Quelle: IQVIA® Arzneimittelverbrauch (AMV) Datenbank: Klinikdaten aus IQVIA DKM® (Deutscher Krankenhaus Markt), Umsatz in Euro zu bewerteten Klinikpreisen, Absatz in Zähleinheiten (ZE); IQVIA PharmaScope® National, Umsatz in Euro zum Abgabepreis des pharmazeutischen Unternehmers ((ApU=Erstattungsbetrag für AMNOG Produkte und Listenpreis für übrige Produkte) ohne Berücksichtigung von Zwangsrabatten und Einsparungen aus Rabattverträgen, Absatz in Zähleinheiten, Berücksichtigung von Zubereitungen ab Jahr 2009, Apothekenumsatz inkl. Impfstoffe IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red 12 Betrachtung Bruttoumsatz von Januar bis März 2026 Pharmamarkt im ersten Quartal 2026: Umsatz- und Absatzveränderung im Apotheken- und Kliniksegment Umsatz Absatz 17,3 Mrd. Euro 25,2 Mrd. ZE +4,6 % -1,2 % 86% 14% Apotheke Klinik 92% 8% Apotheke Klinik © 2026, IQVIA Commercial GmbH & Co. OHG. All rights reserved. – IQVIA Marktbericht | im 1. Quartal 2026 Quelle: IQVIA® AMV Datenbank GPI Krankenhausindex® DKM®, IQVIA PharmaScope® National, Apothekenumsatz inkl. Impfstoffe +1,9 % -0,5 % +5,1 % -1,3 % IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red 13 Aktuelle 12 Monate bis Ende März 2026 Monatliche Entwicklung des Klinik- und Apothekenmarktes im Jahr 04/2025 bis Ende 03/2026 Umsatz (ApU) in +/-% Absatz (ZE) in +/-% Absatz (ZE) in +/-% Umsatz (Euro bewertet) in +/-% Apotheke Klinik 2.3 8.8 5.5 7.8 2.2 7.9 4.4 2.2 10.3 0.4 3.8 11.3 Apr.- 25 Mai- 25 Juni- 25 Juli- 25 Aug.- 25 Sept.- 25 Okt.- 25 Nov.- 25 Dez.- 25 Jan.- 26 Febr.- 26 März- 26 -3.8 1.1 -2.0 0.1 -3.4 0.9 -2.6 -4.8 3.9 -5.4 -2.6 4.3 Apr.- 25 Mai- 25 Juni- 25 Juli- 25 Aug.- 25 Sept.- 25 Okt.- 25 Nov.- 25 Dez.- 25 Jan.- 26 Febr.- 26 März- 26 3.5 0.8 4.4 8.8 -5.7 1.2 3.4 2.0 6.4 -0.3 -0.9 6.9 Apr.- 25 Mai- 25 Juni- 25 Juli- 25 Aug.- 25 Sept.- 25 Okt.- 25 Nov.- 25 Dez.- 25 Jan.- 26 Febr.- 26 März- 26 1.1 -2.3 4.0 -2.6 -3.8 1.2 -1.2 -6.4 3.5 -4.9 -2.5 5.8 Apr.- 25 Mai- 25 Juni- 25 Juli- 25 Aug.- 25 Sept.- 25 Okt.- 25 Nov.- 25 Dez.- 25 Jan.- 26 Febr.- 26 März- 26 © 2026, IQVIA Commercial GmbH & Co. OHG. All rights reserved. – IQVIA Marktbericht | im 1. Quartal 2026 Quelle: IQVIA® Arzneimittelverbrauch (AMV) Datenbank: Klinikdaten aus IQVIA DKM® (Deutscher Krankenhaus Markt), Umsatz in Euro zu bewerteten Klinikpreisen, Absatz in Zähleinheiten (ZE); IQVIA PharmaScope® National, Umsatz in Euro zum Abgabepreis des pharmazeutischen Unternehmers ((ApU=Erstattungsbetrag für AMNOG Produkte und Listenpreis für übrige Produkte) ohne Berücksichtigung von Zwangsrabatten und Einsparungen aus Rabattverträgen, Absatz in Zähleinheiten, Berücksichtigung von Zubereitungen ab Jahr 2010, Apothekenumsatz inkl. Impfstoffe IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal RedEntwicklung im Klinikmarkt IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red 15 7.0 -11.9 -0.7 1.3 15.9 3.8 -8.9 18.8 -2.6 21.6 3.9 1.9 Basis: ATC3-Klassifikation; Umsatzentwicklung in Mio. EUR von Januar bis März 2026 gegenüber Vergleichszeitraum 2025 Klinikmarkt im ersten Quartal 2026: Mehrheitlich Zuwachsraten bei den umsatzstärksten Arzneimittelgruppen © 2026, IQVIA Commercial GmbH & Co. OHG. All rights reserved. – IQVIA Marktbericht | im 1. Quartal 2026 YTD 03/2025 YTD 03/2026 L01G MAB ANTINEOPLASTIKA 807,9 864,8 L01X SONSTIGE ANTINEOPLASTIKA 161,7 142,4 J06C POLYVAL.IMMUNGLOBUL.,I.V 139,4 138,4 M05X SONSTIGE MITTEL GRUPPE M 99,8 101,0 B02D PROD.Z.REGUL.BLUTGERINN. 65,5 75,9 N07A PROD.G.MULTIPLE SKLEROSE 52,6 54,6 L04E KOMPLEMENT INHIBITOREN 54,7 49,8 J06H SPEZIF.ANTIVIR.IMMUNGLOB 38,7 45,9 L04C INTERLEUKIN INHIBITOREN 44,0 42,9 L04X SONST.IMMUNSUPPRESSIVA 27,2 33,1 SUMME TOP 10 1.491,4 1.548,8 GESAMT 2.439,1 2.485,3 Veränderungsrate zum Vorjahr % Quelle: Klinikdaten aus IQVIA DKM® (Deutscher Krankenhaus Markt), Umsatz in Euro zu bewerteten Klinikpreisen IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red 16 0.8 1.5 1.8 2.9 -4.4 -1.4 -1.4 0.1 -3.1 -0.1 -0.5 -16,2 YTD 03/2025 YTD 03/2026 D08A ANTISEPTIKA+DESINFIZIENT 775,7 782,3 N02B SONSTIGE ANALGETIKA 99,1 100,6 S01X SONSTIGE OPHTHALMOLOGIKA 73,5 74,8 A01A STOMATOLOGIKA 47,3 48,6 D02A EMOLLIENTIA+HAUTSCHUTZPR 55,4 46,4 K01B STANDARDLOESUNGEN 39,8 38,1 R01A RHINOLOGIKA, TOPISCH 38,1 37,6 A02B ULCUSTHERAPEUTIKA 33,4 32,9 N05A ANTIPSYCHOTIKA 30,1 30,1 D03A WUNDHEILMITTEL 28,2 27,3 SUMME TOP 10 1.220,5 1.218,7 GESAMT 1.938,6 1.928,1 Basis: ATC3-Klassifikation; Mengenentwicklung in Mio. Zähleinheiten (ZE) von Januar bis März 2026 gegenüber Vergleichszeitraum 2025 Klinikmarkt: Fünf der zehn mengenstärksten Arzneimittelgruppen verzeichnen im Q1/2026 Rückgänge © 2026, IQVIA Commercial GmbH & Co. OHG. All rights reserved. – IQVIA Marktbericht | im 1. Quartal 2026 Quelle: Klinikdaten aus IQVIA DKM® (Deutscher Krankenhaus Markt), Absatz in Zähleinheiten (ZE) Veränderungsrate zum Vorjahr % IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red Entwicklung im Apothekenmarkt IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red 18 -10 -5 0 5 10 15 03/25 04/25 05/25 06/25 07/25 08/25 09/25 10/25 11/25 12/25 01/26 02/26 03/26 ApU; Umsatz- und Absatzentwicklung von 03/2025 bis 03/2026 Apothekenmarkt im ersten Quartal 2026: Umsatzwachstum bei rückläufiger Absatzentwicklung Ve rä nd er un gs ra te in % Absatz in PackungenUmsatz in EUR (ApU*) © 2026, IQVIA Commercial GmbH & Co. OHG. All rights reserved. – IQVIA Marktbericht | im 1. Quartal 2026 Quelle: IQVIA PharmaScope®, Basis: *Umsatz in € zum Abgabepreis des pharmazeutischen Unternehmers (ApU=Erstattungsbetrag für AMNOG Produkte und Listenpreis für übrige Produkte) abzüglich Hersteller-Zwangsrabatten im GKV-Markt, ohne Einsparungen aus Rabattverträgen § 130a SGB V; Absatz in Packungseinheiten. Seit Juli 2009 sind Marktinformationen zum Versandhandel integriert. Je nach Marktsegment und betrachtetem Zeitraum sind hierbei verschiedene Abschlagssätze gültig (6 %, 7 %, 12 %). 5,2 Mrd. € 145,8 Mio Pack. Kumuliert Januar - März 2026: Umsatz 14,8 Mrd. Euro (+4,8 %) Absatz 426,7 Mio. Pack. (-4,1 %) IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red 19 ApU; Umsatz- und Absatzentwicklung von 03/2025 bis 03/2026 Rx-Präparate im Apothekenmarkt im Q1/2026: Positive Umsatzentwicklung bei leicht rückläufigem Absatz -10 -5 0 5 10 15 03/25 04/25 05/25 06/25 07/25 08/25 09/25 10/25 11/25 12/25 01/26 02/26 03/26 Ve rä nd er un gs ra te in % Absatz in PackungenUmsatz in EUR (ApU*) © 2026, IQVIA Commercial GmbH & Co. OHG. All rights reserved. – IQVIA Marktbericht | im 1. Quartal 2026 Quelle: IQVIA PharmaScope®, Basis: *Umsatz in € zum Abgabepreis des pharmazeutischen Unternehmers (ApU=Erstattungsbetrag für AMNOG Produkte und Listenpreis für übrige Produkte) abzüglich Hersteller-Zwangsrabatten im GKV-Markt, ohne Einsparungen aus Rabattverträgen § 130a SGB V; Absatz in Packungseinheiten. Seit Juli 2009 sind Marktinformationen zum Versandhandel integriert. Je nach Marktsegment und betrachtetem Zeitraum sind hierbei verschiedene Abschlagssätze gültig (6 %, 7 %, 12 %). 4,6 Mrd. € 70,0 Mio Pack. Kumuliert Januar - März 2026: Umsatz 13,1 Mrd. Euro (+5,9 %) Absatz 199,5 Mio. Pack. (-1,3 %) IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red 20 ApU; Umsatz- und Absatzentwicklung von 03/2025 bis 03/2026 OTC-Arzneimittel im Apothekenmarkt im Q1/2026: Umsatz und Absatz starten 2026 rückläufig -10 0 10 -15 -5 5 03/25 04/25 05/25 06/25 07/25 08/25 09/25 10/25 11/25 12/25 01/26 02/26 03/26 Ve rä nd er un gs ra te in % Absatz in PackungenUmsatz in EUR (ApU*) © 2026, IQVIA Commercial GmbH & Co. OHG. All rights reserved. – IQVIA Marktbericht | im 1. Quartal 2026 Quelle: IQVIA PharmaScope®, Basis: *Umsatz in € zum Abgabepreis des pharmazeutischen Unternehmers (ApU=Erstattungsbetrag für AMNOG Produkte und Listenpreis für übrige Produkte) abzüglich Hersteller-Zwangsrabatten im GKV-Markt, ohne Einsparungen aus Rabattverträgen § 130a SGB V; Absatz in Packungseinheiten. Seit Juli 2009 sind Marktinformationen zum Versandhandel integriert. Je nach Marktsegment und betrachtetem Zeitraum sind hierbei verschiedene Abschlagssätze gültig (6 %, 7 %, 12 %). 0,6 Mio € 75,7 Mio Pack. Kumuliert Januar - März 2026: Umsatz 1,7 Mrd. Euro (-2,7 %) Absatz 227,2 Mio. Pack. (-6,5 %) IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red 21 ApU; Darstellung des aufgegliederten Apotheken Umsatzes in Mio. € von Januar bis März 2026 Umsatzentwicklung verschiedener Arzneimittelsegmente im Apothekenmarkt im ersten Quartal 2026: Zweistellige Zuwächse bei geschützten Produkten 14.780 Gesamt zu ApU real 13.058 rezeptpflichtig 1.722 rezeptfrei 903 1.262 Altoriginale+ Zweitanbieter, nicht mehr/nie geschützt (chemisch) Originale + Zweitanbieter geschützt (Biotech) 2.871 Altoriginale+ Zweitanbieter, nicht mehr/nie geschützt (Biotech) 2.324 RestgruppeOriginale + Zweit- anbieter geschützt (chemisch ) 4.298 Biosimilar 715 Generika 2.405 Gesamt zu ApU real 14.779 © 2026, IQVIA Commercial GmbH & Co. OHG. All rights reserved. – IQVIA Marktbericht | im 1. Quartal 2026 +1,4% -9,6%+4,8% +6,5% +15,2%+15,1% -21,6% +4,3%+4,8% +5,9% -2,7% Quelle: IQVIA PharmaScope®, Basis: *Umsatz in € zum Abgabepreis des pharmazeutischen Unternehmers (ApU=Erstattungsbetrag für AMNOG Produkte und Listenpreis für übrige Produkte) abzüglich Hersteller-Zwangsrabatten im GKV-Markt, ohne Einsparungen aus Rabattverträgen § 130a SGB V; Absatz in Packungseinheiten. Seit Juli 2009 sind Marktinformationen zum Versandhandel integriert. Je nach Marktsegment und betrachtetem Zeitraum sind hierbei verschiedene Abschlagssätze gültig (6 %, 7 %, 12 %). IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red 22 UN; Darstellung des aufgegliederten Apotheken Absatzes in Tsd. Packungen von Januar bis März 2026 Absatzentwicklung verschiedener Produktsegmente im Apothekenmarkt im ersten Quartal 2026: Geschützte Produkte mit zweistelligem Zuwachs 426.713 Gesamt 199.478 rezeptpflichtig 227.236 rezeptfrei 58.552 Originale + Zweitanbieter geschützt (Biotech) Altoriginale+ Zweitanbieter, nicht mehr/nie geschützt (chemisch) 2.373 2.935 Altoriginale+ Zweitanbieter, nicht mehr/nie geschützt (Biotech) 101.194 RestgruppeOriginale + Zweit- anbieter geschützt (chemisch ) 10.950 Biosimilar 1.333 Generika 249.375 Gesamt 426.713 © 2026, IQVIA Commercial GmbH & Co. OHG. All rights reserved. – IQVIA Marktbericht | im 1. Quartal 2026 -1,2% -8,2%-4,1% +13,1% +15,6%+13,3% -10,5% -9,1%-4,1% -1,3% -6,5% Quelle: IQVIA PharmaScope®, Basis: Absatz in Mio. Packungseinheiten. Seit Juli 2009 sind Marktinformationen zum Versandhandel integriert. IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red Entwicklung im OTC- Apothekenversandhandel und bei rezeptfreien Arznei- und Nichtarznei-mitteln IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red 24 52% 30% 15% 3% 1% 63% 20% 12% 3% 1% Umsatz Jan – März 2026: 966 Mio. Euro (+8,9 %) Absatz Jan – März 2026: 73 Mio. Packungen (+7,2 %) OTC-Versandhandel im ersten Quartal 2026: Umsatz- und Absatzwachstum +11,7 % +8,3 % +5,0 % +11,7 % +10,3 % +10,4 % +6,4 % +5,5 % +6,0 % + 19,7 % OTC*-Arzneimittel Gesundheitsmittel Kosmetik- und Körperpflegeprodukte Produkte des medizinischen Sachbedarfs (z. B. Tests, Hilfsmittel etc.) Ernährung (z. B. Schlankheitsmittel, Traubenzucker etc.) © 2026, IQVIA Commercial GmbH & Co. OHG. All rights reserved. – IQVIA Marktbericht | im 1. Quartal 2026 Quelle: IQVIA® Consumer Report Apotheke, Basis: Umsatz in EUR zum effektiven Verkaufspreis; Absatz in Packungen; *OTC: over the counter (rezeptfrei) IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red 25 +5.0% +2.7% +9.0% +14.4% +10.3% +2.6% +8.8% +16.9% +7.2% +8.9% +7.2% +10.3% Rezeptfreie Arznei- und Nichtarzneimittel, OTCGMS (Gruppen 1-19+97), BRD gesamt, Apotheken- Versandhandel, Ranking OTC-Gruppen im Zeitraum Januar bis März 2026 Absatzstärkste OTC-Arznei- und Gesundheitsmittel im Versandhandel im ersten Quartal 2026: Stärkster Zuwachs bei VMHS* und Augenpräparaten © 2026, IQVIA Commercial GmbH & Co. OHG. All rights reserved. – IQVIA Marktbericht | im 1. Quartal 2026 YTD 03/2026 HUSTEN-/ERKÄLTUNGSMITTEL/ATEMWEGSPRÄPARATE 20.926.791 SCHMERZMITTEL/MUSKEL-/GELENKTHERAPEUTIKA 9.225.514 PROD. F. D. VERDAUUNGSTRAKT 6.767.410 VITAMINE/MINERALSTOFFE/NAHRUNGSERGÄNZUNG 6.722.223 HAUTMITTEL 5.159.002 VERSCHIEDENES 1.592.780 HERZ- UND KREISLAUFMITTEL 2.058.129 AUGENPRÄPARATE 2.419.538 BERUHIGUNGS-/SCHLAFMITTEL/STIMMUNGSAUFH. 1.932.269 MITTEL F.D. BLASE/FORTPFL. ORGANE 1.662.349 SUMME TOP 10 58.466.007 GESAMT 61.254.002 Quelle: IQVIA® Consumer Report Apotheke * Vitamins, Minerals, Herbals, Supplements IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red 26 Rezeptfreie Arznei- und Nichtarzneimittel, OTCGMS (Gruppen 1-19+97), SM-/VO-Umsatz Mio. €, Marktanteil Wert %, Apotheke (Offizin+VH), BRD gesamt Erstes Quartal 2026: Stagnierender Umsatz bei den Rezeptfreien, die über Verordnung und Selbstmedikation erworben werden -0.2 1.4 -3.0 0.0 OTC Gesamt GKV PKV+Grünes Rezept SM 286 (9%) 2.619 (84%) Jan – März 2025 207 (7%) 277 (9%) 2.620 (84%) Jan – März 2026 204 (7%) Jan – März 2024 2.445 (84%) 261 (9%) 2.897 3.109 3.104 191 (7%) +7,3% -0,2% GKV PKV+Grünes Rezept SM © 2026, IQVIA Commercial GmbH & Co. OHG. All rights reserved. – IQVIA Marktbericht | im 1. Quartal 2026 Quelle: IQVIA® Consumer Report Apotheke; Rezeptfreie Arznei- und Nichtarzneimittel, OTCGMS (Gruppen 1-19+97) *Nichtarzneimittel beinhalten z. B. Mineralstoffpräparate, Arzneitees, Hustenbonbons, Hautschutzcremes etc. Veränderung ggü. Vorjahreszeitraum in +/-% Legende: PKV = Privatversicherung/-rezept GKV = Gesetzliche Krankenversicherung/-rezept SM = Selbstmedikation OTCGMS = Rezeptfreie Arznei- und Nichtarzneimittel gesamt IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red 27 Rezeptfreie Arznei- und Nichtarzneimittel, OTCGMS (Gruppen 1-19+97), SM-/VO-Absatz Mio. Pack, Marktanteil Menge %, Apotheke (Offizin+VH) BRD-Gesamt Erstes Quartal 2026: Rückläufiger Absatz der Rezeptfreien, die über Verordnungen und Selbstmedikation erworben werden 16 (6%) 18 (7%) 218 (87%) Jan – März 2026 219 (87%) 18 (7%) 251 262 252 16 (6%) Jan – März 2025 226 (87%) 19 (7%) 17 (6%) Jan – März 2024 +4,5% -3,8% GKV PKV+Grünes Rezept SM -3.8 -6.0 -7.4 -3.4 OTC Gesamt GKV PKV+Grünes Rezept SM Legende: PKV = Privatversicherung/-rezept GKV = Gesetzliche Krankenversicherung/-rezept SM = Selbstmedikation OTCGMS = Rezeptfreie Arznei- und Nichtarzneimittel gesamt © 2026, IQVIA Commercial GmbH & Co. OHG. All rights reserved. – IQVIA Marktbericht | im 1. Quartal 2026 Quelle: IQVIA® Consumer Report Apotheke; Rezeptfreie Arznei- und Nichtarzneimittel, OTCGMS (Gruppen 1-19+97) *Nichtarzneimittel beinhalten z. B. Mineralstoffpräparate, Arzneitees, Hustenbonbons, Hautschutzcremes etc. Veränderung ggü. Vorjahreszeitraum in +/-% IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red Entwicklung im GKV-Markt IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red 29 AVP real; Marktentwicklung von 03/2025 bis 03/2026 GKV-Arzneimittelausgaben im ersten Quartal 2026 © 2026, IQVIA Commercial GmbH & Co. OHG. All rights reserved. – IQVIA Marktbericht | im 1. Quartal 2026 -8 -4 -2 0 2 4 6 8 10 -6 03/25 04/25 06/25 07/25 08/25 09/25 10/25 11/25 12/25 01/26 02/26 03/2605/25 Absatz in PackungenUmsatz in EUR zu AVP abzgl. Zwangsrabatten 63,8 Mio Pack. 5,2 Mrd Euro Ve rä nd er un gs ra te z um V or ja hr in % Kumuliert Januar - März 2026: Umsatz 15,0 Mrd. Euro (+3,6 %) Absatz 183,25 Mio. Pack. (-2,8 %) Quelle: IQVIA PharmaScope®, Basis: *Umsatz in Euro zum Apothekenverkaufspreis (AVP) abzüglich der von Herstellern und Apotheken zu leistenden Zwangsrabatte, abzüglich gemeldeter Rabatte aus Erstattungsbeträgen nach §130 SGB V; ohne Einsparungen aus Rabattverträgen; Absatz in Packungseinheiten; ohne Impfstoffe Je nach Marktsegment und betrachtetem Zeitraum sind hierbei verschiedene Abschlagssätze gültig (6%, 7%, 12%). Absatz in PackungenUmsatz in EUR zu AVP abzgl. Zwangsrabatten IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red 30 Umsatz * in Mio. Euro L01G MAB ANTINEOPLASTIKA 1.092,6 L01H PROTEINKIN.HEMM.A.NEOPL. 849,3 L04C INTERLEUKIN INHIBITOREN 678,4 L04B ANTI-TNF PRODUKTE 546,3 B01F DIREKTE FAKTOR XA HEMMER 545,0 A10P SGLT2-HEMMER ANTIDIABET. 529,5 N07A PROD.G.MULTIPLE SKLEROSE 404,8 L02B CYTOSTAT.HORMONANTAGON. 394,8 A10S GLP-1 AGONISTEN ANTIDIAB 348,8 A10C HUMANINSULIN UND ANALOGA 282,7 SUMME TOP 10 5.672,2 GESAMT 14.958,9 AVP real; GKV- Markt, Top 10 Arzneimittelgruppen nach Umsatz, +/- Umsatz/ Absatz (%) im Januar bis März 2026 Umsatzstärkste Arzneimittel im GKV-Markt im ersten Quartal 2026 : Mehrheitliche Zuwächse nach Wert, Mengenentwicklung uneinheitlich 0.8 8.6 18.1 0.3 -22.0 13.1 -5.0 8.6 30.2 -2.5 3.1 3.6 -7.8 7.1 21.0 3.4 4.8 12.7 -1.2 4.7 19.1 -5.6 5.0 -2.8 +/- Umsatz +/- Absatz © 2026, IQVIA Commercial GmbH & Co. OHG. All rights reserved. – IQVIA Marktbericht | im 1. Quartal 2026 Quelle: IQVIA PharmaScope®, Absatz in Packungen, ohne Impfstoffe; *Umsatz in Euro zum Apothekenverkaufspreis (AVP) abzüglich der von Herstellern und Apotheken zu leistenden Zwangsrabatte, abzüglich gemeldete Rabatte aus Erstattungsbeträgen nach §130 SGB V; ohne Einsparungen aus Rabattverträgen; Absatz in Packungseinheiten; ohne Impfstoffe Je nach Marktsegment und betrachtetem Zeitraum sind hierbei verschiedene Abschlagssätze gültig (6%, 7%, 12%). IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red 31 Absatz * in Mio. Units N02B SONSTIGE ANALGETIKA 13,3 C07A BETA-BLOCKER REIN 9,6 C10A LIPIDREGULATOREN 8,5 M01A NICHTSTEROID.ANTIRHEUMAT 7,4 A02B ULCUSTHERAPEUTIKA 7,0 C09C ANGIOTENS.II-ANTAGO.REIN 6,9 H03A THYREOIDPRAEPARATE 6,5 C08A CALCIUMANTAGONISTEN,REIN 6,1 N06A ANTIDEPRESS+STIMM.STABIL 5,9 C03A DIURETIKA 5,9 SUMME TOP 10 77,1 GESAMT 183,3 UN; GKV- Markt, Top 10 Arzneimittelgruppen nach Absatz, +/- Umsatz/ Absatz (%) im Januar bis März 2026 Absatzstärkste Arzneimittelgruppen im GKV-Markt im Q1/2026: Mehrheitliche Zuwächse nach Wert, gemischte Absatzentwicklungen © 2026, IQVIA Commercial GmbH & Co. OHG. All rights reserved. – IQVIA Marktbericht | im 1. Quartal 2026 -2.3 0.1 6.8 -5.8 -2.1 5.8 0.4 7.1 4.1 1.4 1.6 3.6 -5.7 -0.2 4.5 -7.0 -2.6 7.2 -0.6 3.1 2.6 1.1 -0.5 -2.8 +/- Umsatz +/- Absatz Quelle: IQVIA PharmaScope®, Absatz in Packungen, ohne Impfstoffe; *Umsatz in Euro zum Apothekenverkaufspreis (AVP) abzüglich der von Herstellern und Apotheken zu leistenden Zwangsrabatte, abzüglich gemeldete Rabatte aus Erstattungsbeträgen nach §130 SGB V; ohne Einsparungen aus Rabattverträgen; Absatz in Packungseinheiten; ohne Impfstoffe Je nach Marktsegment und betrachtetem Zeitraum sind hierbei verschiedene Abschlagssätze gültig (6%, 7%, 12%). IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red 32 Vergleich der Zwangsabgänge und Rabatte in Jan – März 2025 und 2026 Hersteller-Zwangsabschläge und Rabatte im ersten Quartal 2026 © 2026, IQVIA Commercial GmbH & Co. OHG. All rights reserved. – IQVIA Marktbericht | im 1. Quartal 2026 43 2.543 Jan – März 2025 40 2.828 Jan – März 2026 2.585 2.869 +11% Jan – März 2025 Jan – März 2026 279 286 +3% 17 372 Jan – März 2025 18 424 Jan – März 2026 389 442 +14% Quelle: *IQVIA PharmaScope®, *7 % inkl. Zusatzabschlägen infolge des Preismoratoriums , inkl. Generikarabatt, inkl. Rabatte für Zubereitungen; inkl. Rabatte aus gemeldeten Erstattungsbeträgen nach §130 SGB V (AMNOG-Rabatte); Herstellerabschlag Ambulanz außerhalb Budget. Generika-Rabatt 7% & AMNOG-Rabatt* Generika-Rabatt 7% & AMNOG-Rabatt* Zwangsabschläge in allen Marktsegmenten (3,6 Mrd. Euro) GKV-Markt* Krankenhaus PKV-Markt* Eu ro in M io . IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red 33 Anzahl Arbeitstage in den Jahren 2023, 2024 und 2025 Kalendereffekte zur Marktbetrachtung 2023 - 2026 Januar Februar März April Mai Juni Juli August Sept. Okt. Nov. Dez. Differenz aktuelles gegenüber Vorjahr -1* - +1* - -1/-2* +2/+3* - +2* --- +1* +1/+2* +1 2023 21/22* 20 22/23* 18 20 21/22* 21 22/23* 20/21* 20/21* 21/22* 19 2024 22 21 20 21 19/20* 20 23* 20-22* 20/21* 21/22* 20/19* 20 2025 21/22* 20 21 20 19/20* 19/20* 23 19-21* 22 21/22* 19/20* 21 2026 20/21* 20 22 20 18 21/22* 23 21 22 22 21 22 © 2026, IQVIA Commercial GmbH & Co. OHG. All rights reserved. – IQVIA Marktbericht | im 1. Quartal 2026 Quelle: https://www.schnelle-online.info/Arbeitstage/Anzahl-Arbeitstage-2023.html; * Unterschiede je nach Bundesland IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red 34 IQVIA DKM® (Deutscher Krankenhaus Markt): Arzneimittel- Verbrauchsstudie der IQVIA Krankenhausforschung. Über die jeweils versorgende Klinikapotheke werden monatlich Ver- brauchsdaten auf Basis von Fachabteilungen und Stationen erhoben. Ermittelt wird das Absatz- und bewertet das Umsatz- volumen des kompletten Klinikmarktes sowie dessen Entwick- lung gegenüber dem Vorjahreszeit-raum. Die Datenbasis bilden rund 480 Panelkrankenhäuser. Die Hochrechnung erfolgt nach 4 Bettengrößenklassen, 15 Fach- richtungen und 7 Regionen. IQVIA PharmaScope®: Die Daten umfassen die Arzneimittelab- gaben der Apotheken für den GKV-Markt, Privatrezepte und Barverkäufe auf Basis der Abgaben der öffentlichen Apotheken. Datenbasis für den GKV-Markt sind von den Apothekenrechen- zentren getätigte GKV-Abrechnungen. Der Anteil der Privat- rezepte und Abgaben ohne Rezept werden auf Basis einer Stichprobe von rund 8.500 Apotheken erhoben. Marktinformationen zum Versandhandel umfassen die Einkäufe der deutschen Verbraucher beim Versandhandel. Dazu bildet ein Versandhandelspanel die Grundlage, die um eine Projektion ergänzt wird. Der IQVIA® Consumer Report Apotheke ist eine kontinuierliche Marktstudie über die Verkäufe von rezeptfreien Arzneimitteln und Nichtarzneimitteln/diätetischen Lebensmitteln sowie Medizinprodukten in öffentlichen Apotheken und Versandhandelsapotheken in Deutschland. Die Verkäufe in öffentlichen Apotheken in Deutschland werden über eine repräsentative Stichprobe von rund 8.500 Apotheken erfasst und hochgerechnet. Informationen zum Apothekenversand werden durch eine gesonderte Projektion aus dem IQVIA Versandhandels-panel ermittelt. Außerdem gehen Verkäufe von öffentlichen Apotheken ein, sofern sie als Versandhandelsverkäufe deklariert werden. Datenquellen © 2026, IQVIA Commercial GmbH & Co. OHG. All rights reserved. – IQVIA Marktbericht | im 1. Quartal 2026 IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red 35 Der Marktbericht enthält monatliche Auswertungen zum Pharma-Gesamtmarkt sowie zu den Bereichen Klinikmarkt, Apothekenmarkt OTC-Apothekenmarkt und GKV-Markt. Dabei unterscheiden sich je nach Sichtweise der Warenkorb und/oder die Variablen für die Darstellung des Absatzes und Umsatzes. Klinikmarkt Die Auswertungen zum Klinikmarkt zeigen den Verbrauch von Arzneimitteln in deutschen Krankenhäusern. Der Absatz wird auf Basis von Zähleinheiten (=ZE; Tabletten, Kapseln, Portionsbeutel, Injektionen etc.) erfasst. Die Berech- nung des Umsatzes erfolgt mithilfe eines bewerteten Preises pro Zähleinheit. Dadurch sind Rabatte, die die pharmazeutischen Hersteller den versorgenden Klinikapotheken gewähren, mitberücksichtigt. Pharma-Gesamtmarkt Alle Auswertungen zum Pharma-Gesamtmarkt beinhalten den Umsatz und Absatz im Klinikmarkt und Apothekenmarkt. Um eine Marktsumme zu bilden, wird in dieser Darstellung der Absatz im Apothekenmarkt wie im Klinikmarkt ebenfalls in Zähl- einheiten (Tabletten, Kapsel, Portionsbeutel etc.) umgerechnet gezeigt. Anders als für den Klinikmarkt beruhen die Umsatzvolumina für das Segment Apotheke auf dem Listenpreis zu ApU (=Abgabepreis des pharmazeutischen Unternehmers bzw. Erstattungsbetrag für AMNOG Produkte). Abschläge und Einsparungen aus Rabatt-verträgen sind hierbei nicht berücksichtigt. Apothekenmarkt Die Analysen zum Apothekenmarkt zeigen den Absatz von abgegebenen Packungen rezeptfreier und rezeptpflichtiger Arzneimittel. Das gezeigte Umsatzvolumen wird mit den Listenpreisen auf der Preisstufe ApU (=Abgabepreis des pharmazeutischen Unternehmers bzw. Erstattungsbetrag für AMNOG Produkte) berechnet. Außerdem werden Hersteller- abschläge und Abschläge aufgrund des Preismoratoriums in Abzug gebracht. Erläuterungen zu den Auswertungen im IQVIA Marktbericht (1) © 2026, IQVIA Commercial GmbH & Co. OHG. All rights reserved. – IQVIA Marktbericht | im 1. Quartal 2026 IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red 36 OTC-Apothekenmarkt Die Auswertungen zum OTC-Apothekenmarkt unterscheiden sich in zwei Punkten von den übrigen Analysen über den Apothekenmarkt. Zum einen wird ein anderer Warenkorb verwendet, der neben rezeptfreien Arzneimitteln auch Gesundheitsmittel berücksichtigt. Zum anderen ist die Preisbasis für die Berechnung des Umsatzes der effektive Verkaufspreis. Dies ist der Preis, zu dem der Verbraucher OTC-Arznei- und Gesundheitsmittel in den Apotheken oder über den Versandhandel erwirbt. GKV-Markt In diesem Kapitel zeigt der Marktbericht die Ausgaben- und Mengenentwicklung der gesetzlichen Krankenversicherung für Arzneimittel aus Offizin-Apotheken und dem Apothekenversand- handel. Der Absatz wird als Anzahl Packungen erfasst und gezeigt. Die Ausgaben werden mithilfe des Apothekenverkaufspreises (AVP) abzüglich der von Herstellern und Apotheken zu leistenden Abschlägen, gemeldeter Rabatte aus Erstattungsbeträgen nach §130b SGB V und der Einsparungen aus Rabattverträgen nach §130a Abs. 8 SGB V (lt. BMG- Veröffentlichungen) berechnet. Der Apothekenverkaufspreis ist der Preis, der den gesetzlichen Krankenversicherungen in Rechnung gestellt wird. Weitere Analysen zum GKV-Markt zeigen die Entwicklung der Hersteller- bzw. Apothekenabschläge für einzelne Monate bzw. den kumulierten Jahreswert im laufenden Kalenderjahr. Erläuterungen zu den Auswertungen im IQVIA Marktbericht (2) © 2026, IQVIA Commercial GmbH & Co. OHG. All rights reserved. – IQVIA Marktbericht | im 1. Quartal 2026 IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red 37 KONTAKT IQVIA Commercial GmbH & Co. OHG Unterschweinstiege 2 - 14 60549 Frankfurt am Main Tel.: 0 69 6604-0 E-Mail: info.germany@iqvia.com www.iqvia.de LinkedIn 11 .2 02 5. CE SE .G er m an Über IQVIA IQVIA (IQVIA (NYSE:IQV) ist ein weltweit führender Anbieter von klinischen Forschungsdienstleistungen, Marktforschung und intelligenten Lösungen für die Life-Sciences- und Gesundheitsbranche. Das Portfolio basiert auf IQVIAs Ansatz der Connected Intelligence und bietet Erkenntnisse und Dienstleistungen an, die auf hochwertigen Gesundheitsinformationen aus aller Welt, der hauseigenen Healthcare-grade AI® sowie fortschrittlicher Analytik mit den neuesten Technologien und umfassender Fachkompetenz beruhen. IQVIA verpflichtet sich zu dem verantwortungsvollen Einsatz von KI. Die von IQVIA verwendeten KI-gestützten Methoden basieren auf den strengsten Datenschutzvorgaben mit aller notwendiger regulatorischer Konformität und Patientensicherheit. IQVIAs KI Healthcare-grade AI® erfüllt die hohen Anforderungen der Branche an Vertrauen, Skalierbarkeit und Präzision. Mit rund 93.000 Mitarbeitenden in über 100 Ländern – darunter Experten aus dem Gesundheitswesen, den Life Sciences, den Datenwissenschaften und zugehöriger Technologieentwicklung sowie Fachkräften in operativer Exzellenz – setzt sich IQVIA für die Entwicklung und Beschleunigung der Vermarktung innovativer, medizinischer Behandlungen ein, um die Patientenversorgung und die Gesundheit der Bevölkerung weltweit zu verbessern. IQVIA ist globaler Vorreiter beim Schutz der Privatsphäre von Patienten. Das Unternehmen nutzt eine Vielzahl von datenschutzfördernden Technologien und Schutzmaßnahmen, um die individuelle Privatsphäre zu wahren und gleichzeitig Informationen in einem Umfang zu generieren und zu analysieren, der es Gesundheitsakteuren ermöglicht, Krankheitsmuster zu erkennen und präzise Therapiepfade für bessere Behandlungsergebnisse zu identifizieren. Die Erkenntnisse und Umsetzungskompetenzen von IQVIA helfen Biotech-, Medizintechnik- und Pharmaunternehmen ebenso wie Forschenden, Regierungsbehörden, Kostenträgern und anderen Akteuren im Gesundheitswesen. Ziel ist, ein tieferes Verständnis von Krankheiten, menschlichem Verhalten und wissenschaftlichem Fortschritt zu erlangen, um den Weg zu Heilungen zu ebnen. Weitere Informationen unter: www.iqvia.de © 2026, IQVIA Commercial GmbH & Co. OHG. All rights reserved. – IQVIA Marktbericht | im 1. Quartal 2026 mailto:info.germany@iqvia.com?subject=IQVIA%20Marktbericht http://www.iqvia.de/ https://www.linkedin.com/company/iqvia-germany/ http://www.iqvia.de/ IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red 38 Impressum Herausgeber: IQVIA Commercial GmbH & Co. OHG, Registergericht Frankfurt am Main HR B 46001. Persönlich haftende Gesellschafter sind: IQVIA Commercial Beteiligungsgesellschaft mbH, Frankfurt am Main, Registergericht Frankfurt am Main, HR B 46001 Geschäftsführer: Dr. Frank Wartenberg (Vorsitzender), Karsten Immel Redaktion: Sabine Kluge Kontakt: IQVIA Pressestelle Sabine Kluge, Tel. 069 6604 4888 E-Mail: sabine.kluge@iqvia.com Copyright: IQVIA Marktbericht ist ein regelmäßig erscheinender Newsletter. Alle Angaben und Informationen in diesem IQVIA Newsletter wurden sorgfältig zusammen- gestellt und geprüft. Die gegebenenfalls in Zusammenhang mit Daten verwendeten Begriffe „Patient, Arzt, Arztpraxis, Verordner oder Apotheke“ bezeichnen keine personenbezogenen, sondern ausschließlich (nach § 3 Abs. 6 Bundesdatenschutzgesetz) anonyme Informationen. Für die Richtigkeit, Aktualität und Vollständigkeit der Informationen wird keine Haftung übernommen. Alle Angaben und Inhalte sind ohne Gewähr. Irrtum und Änderungen vorbehalten. Slide 0: IQVIA MARKTBERICHT Slide 1 Slide 2 Slide 3: Inhaltsverzeichnis Slide 4: Zusammenfassung: Pharma-Gesamtmarkt (Apotheke u. Klinik) Slide 5: Zusammenfassung: Apothekenmarkt Slide 6: Zusammenfassung: GKV-Markt Slide 7: Summary: Total Pharmaceutical Market (Pharmacy & Hospital) Slide 8: Summary: Total Retail Market Slide 9: Summary: Statutory Health Insurance Market (SHI) Slide 10: Entwicklung im Pharma-Gesamtmarkt (Apotheke und Klinik) Slide 11: Pharma-Gesamtmarkt im ersten Quartal 2026: Positive Umsatzveränderung bei leicht rückläufigem Absatz Slide 12: Pharmamarkt im ersten Quartal 2026: Umsatz- und Absatzveränderung im Apotheken- und Kliniksegment Slide 13: Monatliche Entwicklung des Klinik- und Apothekenmarktes im Jahr 04/2025 bis Ende 03/2026 Slide 14: Entwicklung im Klinikmarkt Slide 15: Klinikmarkt im ersten Quartal 2026: Mehrheitlich Zuwachsraten bei den umsatzstärksten Arzneimittelgruppen Slide 16: Klinikmarkt: Fünf der zehn mengenstärksten Arzneimittelgruppen verzeichnen im Q1/2026 Rückgänge Slide 17: Entwicklung im Apothekenmarkt Slide 18: Apothekenmarkt im ersten Quartal 2026: Umsatzwachstum bei rückläufiger Absatzentwicklung Slide 19: Rx-Präparate im Apothekenmarkt im Q1/2026: Positive Umsatzentwicklung bei leicht rückläufigem Absatz Slide 20: OTC-Arzneimittel im Apothekenmarkt im Q1/2026: Umsatz und Absatz starten 2026 rückläufig Slide 21: Umsatzentwicklung verschiedener Arzneimittelsegmente im Apothekenmarkt im ersten Quartal 2026: Zweistellige Zuwächse bei geschützten Produkten Slide 22: Absatzentwicklung verschiedener Produktsegmente im Apothekenmarkt im ersten Quartal 2026: Geschützte Produkte mit zweistelligem Zuwachs Slide 23: Entwicklung im OTC-Apothekenversandhandel und bei rezeptfreien Arznei- und Nichtarznei-mitteln Slide 24: OTC-Versandhandel im ersten Quartal 2026: Umsatz- und  Absatzwachstum Slide 25: Absatzstärkste OTC-Arznei- und Gesundheitsmittel im Versandhandel im ersten Quartal 2026: Stärkster Zuwachs bei VMHS* und Augenpräparaten Slide 26: Erstes Quartal 2026: Stagnierender Umsatz bei den Rezeptfreien, die über Verordnung und Selbstmedikation erworben werden Slide 27: Erstes Quartal 2026: Rückläufiger Absatz der Rezeptfreien, die über Verordnungen und Selbstmedikation erworben werden Slide 28: Entwicklung im GKV-Markt Slide 29: GKV-Arzneimittelausgaben im ersten Quartal 2026 Slide 30: Umsatzstärkste Arzneimittel im GKV-Markt im ersten Quartal 2026 : Mehrheitliche Zuwächse nach Wert, Mengenentwicklung uneinheitlich Slide 31: Absatzstärkste Arzneimittelgruppen im GKV-Markt im Q1/2026: Mehrheitliche Zuwächse nach Wert, gemischte Absatzentwicklungen Slide 32: Hersteller-Zwangsabschläge und Rabatte im ersten Quartal 2026 Slide 33: Kalendereffekte zur Marktbetrachtung 2023 - 2026 Slide 34: Datenquellen Slide 35: Erläuterungen zu den Auswertungen im IQVIA Marktbericht (1) Slide 36: Erläuterungen zu den Auswertungen im IQVIA Marktbericht (2) Slide 37 Slide 38

Pharma-Gesamtmarkt und Klinikmarkt: Die monatliche Entwicklung des Klinik- und Apothekenmarktes zeigt im ersten Quartal 2026 eine insgesamt positive Dynamik. Im 1. Quartal 2026 steigt der Umsatz mit Arzneimitteln im gesamten Pharmamarkt (Apotheke und Klinik) um 4,6%. Der Absatz ist leicht rückläufig (-1,2%). Es wurden in den ersten drei Monaten dieses Jahres 25,2 Mrd. Zähleinheiten (ZE; z.B. Kapseln, Hübe, Portionsbeutel etc.) im Wert von 17,3 Mrd. Euro an Patientinnen und Patienten abgegeben. Zur Monatsentwicklung: In den ersten beiden Monaten des Jahres verlief die Umsatzentwicklung im Kliniksegment weitgehend stagnierend, bevor es im März zu einer Belebung kam (Umsatzwachstum von knapp +7% vs. VJ). Ein ähnliches Muster zeigt sich beim Absatz im Klinikmarkt mit zunächst stärker rückläufigen Absatzentwicklungen im Januar und Februar, gefolgt von einer positiven Dynamik im März von fast +6%. Auch im Apothekenmarkt liegen die Absatzveränderungsraten in den ersten beiden Monaten im negativen Bereich. Die Umsatzveränderung entwickelt sich hingegen positiv und beschleunigte im Verlauf der ersten drei Monate von einer zunächst schwachen Wachstumsrate bis zu dem höchsten Zuwachs im März von +11,3% gegenüber Vorjahresmonat. Insgesamt verzeichnete der Apothekenmarkt im ersten Quartal 2026 ein Umsatzwachstum von +4,8% im Vgl. mit Q1/2025 auf 14,8 Mrd. Euro. Es wurden 426,7 Mio. Packungen an Patientinnen und Patienten abgegeben, was einer rückläufigen Absatzentwicklung von -4% vs. Vorjahreszeitraum entspricht. Die GKV-Arzneimittelausgaben steigen im Vergleich zum Vorjahreszeitraum Q1/2025 um +3,6% auf 15 Mrd. Euro. Die Absatzveränderung nach Packungen fällt in dieser Marktbetrachtung um -2,8% auf 183,3 Millionen. Im Klinikmarkt entfallen im ersten Quartal 2026 rund 62,3% des Gesamtumsatzes im stationären Sektor auf die zehn umsatzstärksten Arzneimittelgruppen (ca. 1,55 Mrd. Euro). Drei der zehn Gruppen weisen zweistellige Umsatzzuwachsraten auf; den stärksten Zuwachs von +21,6% vs. VJ verzeichnet die Gruppe L04X (Sonstige Immunsuppressiva), die vor allem bei hochspezialisierten Immuntherapien Anwendung findet. Bei den mengenstärksten Arzneimittelgruppen im Klinikmarkt zeigt sich ein uneinheitliches Bild im 1. Quartal: Fünf der zehn absatzstärksten Gruppen verzeichnen rückläufige Veränderungsraten. Apotheken-Gesamtmarkt: Der Apothekenmarkt verzeichnet im ersten Quartal 2026 ein Umsatzwachstum von +4,8% gegenüber dem Vorjahreszeitraum. Der Absatz ist im gleichen Zeitraum rückläufig (-4,1%). Insgesamt wurden 426,7 Mio. Packungen im Wert von 14,8 Mrd. Euro (zum Abgabepreis des pharmazeutischen Unternehmers, inkl. Impfstoffe und Testdiagnostika) an Patientinnen und Patienten abgegeben. Die Monatsentwicklung zeigt eine zunehmende Dynamik: Die Umsatzveränderungsraten steigen von zunächst unter einem Prozent zu Jahresbeginn auf rund +11% im März. Die rückläufige Absatzentwicklung schwächt sich im Quartalsverlauf ab von etwa -7% auf nahezu stabile Werte im März (knapp unter 1%). Das Segment der rezeptpflichtigen Präparate aus dem Apothekenmarkt wächst im Q1 2026 nach Umsatz um knapp +6% vs. VJ, während der Absatz weiter leicht rückläufig verbleibt (-1,3 %). Dies entspricht einem Marktvolumen von rund 13,1 Mrd. Euro sowie 199,5 Mio. abgegebenen Packungen. Wachstumstreiber sind insbesondere patentgeschützte Produkte. Auch Biosimilars verzeichnen im Apothekenmarkt ein deutliches Absatzwachstum von +15,6 %. Im Segment der rezeptfreien Arzneimittel wurden in den ersten drei Monaten 2026 insgesamt 227,2 Mio. Packungen im Apothekenmarkt abgegeben (-6,5% gegenüber Vorjahreszeitraum). Auch der Umsatz ist rückläufig und sank um -2,7% auf 1,7 Mrd. Euro. Die Entwicklung der rezeptfreien Arznei- und Gesundheitsmittel betrachtet nach Rezepttyp und Selbstmedikation zeigt eine differenzierte Dynamik: Die GKV-Verordnungen verzeichnen mit +1,4% den höchsten Zuwachs. Dagegen sind die Empfehlungen über das Grüne Rezept sowie PKV-Verordnungen in Summe um -3% rückläufig. Es ist zu berücksichtigen, dass diese beiden Rezeptarten in manchen Apothekensystemen nicht immer eindeutig getrennt erfasst werden und das „Grüne Rezept“ mitunter als „Privat-Rezept“ verbucht wird. Die Selbstmedikation, die den Löwenanteil in dieser Marktbetrachtung auf sich vereint, zeigt eine stabile bis leicht rückläufige Umsatzentwicklung und einen um -3,4% gesunkenen Absatz im ersten Quartal. Der Versandhandelsmarkt der rezeptfreien Arznei- und Nichtarzneimittel legt im ersten Quartal 2026 nach Wert um knapp 9% zu (966 Mio. Euro). Die abgesetzte Menge steigt um +7,2% auf 73 Mio. Packungen. Bei den absatzstärksten Arznei- und Gesundheitsmittelgruppen im Versandhandel wachsen Augenpräparate mit rund +17% am stärksten, gefolgt von der Gruppe der Vitamine, Mineralstoffe und Nahrungsergänzungen (+14,4%). Die Erkältungsmittel inkl. Husten- und Atemwegspräparate legen um moderate + 5% zu. HINWEIS: Die Basis der hier dargestellten Umsatzwerte bildet soweit nicht anders vermerkt der Abgabepreis des pharmazeutischen Unternehmers abzüglich der Herstellerabschläge und der gemeldeten Rabatte aus Erstattungsbeträgen nach § 130b SGB V. Einsparungen aus Rabattverträgen nach § 130a Abs. 8 SGB V sind nicht berücksichtigt. Das „Grüne Rezept“ und „Privat-Rezept“ werden in Summe ausgewiesen, da die Verbuchung in manchen Apothekensystemen nicht immer differenziert erfolgt. So wird das „Grüne Rezept“ mitunter auch als „Privat-Rezept“ interpretiert und verbucht. GKV-Markt: Die GKV-Arzneimittelausgaben abzüglich der Abschläge von Herstellern (§ 130a Abs. 1 SGB V) und Apotheken (ohne Berücksichtigung von Einsparungen aus Rabattverträgen) belaufen sich im ersten Quartal 2026 auf 15,0 Mrd. Euro. Das entspricht einem Anstieg von +3,6% gegenüber Vorjahreszeitraum. Der Absatz beträgt im gleichen Zeitraum 183,25 Mio. abgegebene Packungen und liegt damit um –2,8% unter dem Vorjahresniveau. Innerhalb der zehn umsatzstärksten Arzneimittelgruppen im GKV-Markt der ersten drei Monate 2026 verzeichnet die Gruppe der GLP-1 Agonisten (Antidiabetika) weiterhin die höchsten Zuwächse mit +30,2%. Weitere zweistellige Zuwachsraten nach Umsatz zeigen Interleukin Inhibitoren (+18%) und SGLT2-Hemmer (Antidiabetika; +13%). Moderate Zuwächse im oberen einstelligen Bereich weist die Gruppe der Proteinkinase-Hemmer (antineoplastische und immunmodulierende Mittel; +8,6%) auf. Bei den zehn absatzstärksten Produktgruppen im GKV-Markt weisen Lipidregulatoren und reine Calciumantagonisten die höchsten Zuwächse mit jeweils rund +7% nach Wert auf. Die Einsparungen der gesetzlichen Krankenversicherung durch Herstellerzwangsabschläge und Rabatte aus Erstattungsbeträgen belaufen sich in den ersten drei Monaten des Jahres 2026 auf 2,869 Mrd. Euro (+11%). Auch für die privaten Krankenversicherungen steigen die Einsparungen durch Herstellerzwangsabschläge und Rabatte aus Erstattungsbeträgen. Dieses berechnete Volumen beläuft sich im ersten Quartal 2026 auf 442 Mio. Euro* (+14%). Im Krankenhaus steigen die Herstellerzwangsabschläge und Rabatte um +3% auf 70 Mio. Euro. * berechnetes Einsparvolumen ohne Berücksichtigung von späteren Einreichungen, Beihilfeleistungen etc. HINWEIS: Die Basis der hier dargestellten Umsatzwerte bildet der Apothekenverkaufspreis abzüglich der Herstellerabschläge und der gemeldeten Rabatte aus Erstattungsbeträgen nach § 130b SGB V sowie der Apothekennachlässe. Einsparungen aus Rabattverträgen § 130a Abs. 8 SGB V sind nicht berücksichtigt. Der IQVIA™ Marktbericht basiert ab dem 3. Quartal 2025 auf der neuen IQVIA Data Integration Platform (DIP). Die Prozessierung über die neue DIP-Plattform bietet eine noch präzisere Informationsaufbereitung der auf Apothekenrechenzentren basierenden Rx-Daten durch innovative Verbesserungen mit hoher Business-Relevanz.

1 Stakeholder consultation on the Draft Guidelines on the classification of high-risk AI systems under Article 6 of the AI Act Fields marked with * are mandatory. Stakeholder consultation on the Draft Guidelines on the classification of high-risk AI systems under Article 6 of the AI Act  This document is a working document of the AI Office for the purpose of consultationDisclaimer: and does not prejudge the final decision that the Commission may take on the final guidelines. The responses to this consultation paper aim to provide relevant stakeholder input to the Commission when finalising the guidelines.  This consultation is targeted to stakeholders of different categories. These categories include, but are not limited to, providers and deployers of (high-risk) AI systems, other industry organisations, as well as academia, other independent experts, civil society organisations, and public authorities and the citizens.   The Artificial Intelligence Act (the ‘AI Act’), which entered into force on 1 August 2024, creates a single market and harmonised rules for trustworthy and human-centric Artificial Intelligence (AI) in the EU. It aims to promote innovation and uptake of AI, while ensuring a high level of protection of health, safety and fundamental rights, including democracy and the rule of law. The AI Act follows a risk-based approach classifying AI systems into different risk categories, one of which is the high-risk AI systems (Chapter III of the AI Act). The AI Act distinguishes between two categories of AI systems that are considered as ‘high-risk’, as set out in Article 6(1) and 6(2) AI Act. Article 6(1) AI Act covers AI systems that are embedded as safety components in products or that themselves are products covered by Union legislation in Annex I, which could have an adverse impact on health and safety of persons. Article 6(2) AI Act covers AI systems that in view of their intended purpose are considered to pose a significant risk to health, safety or fundamental rights. The AI Act lists eight areas in which AI systems could pose such significant risk to health, safety or fundamental rights in Annex III and, within each area, lists specific use-cases that are to be classified as high-risk. Article 6(3) AI Act provides for exemptions for AI systems that are intended to be used for one of the use-cases listed in Annex III, but which do not pose significant risk since they fall under one of the exceptions listed in Article 6(3) AI Act. With the   the entry into application of the requirements and obligations for high-risk AI systemsAI Omnibus https://digital-strategy.ec.europa.eu/en/news/eu-agrees-simplify-ai-rules-boost-innovation-and-ban-nudification-apps-protect-citizens 2 under Article 6(2) and Annex III will be postponed to 2 December 2027. As regards the AI systems under Article 6(1) and Annex I the rules will apply from 2 August 2028. Other changes introduced to the classification rules under Article 6(1) and the definition of a 'safety component' are considered in the draft guidelines.  The draft Guidelines relate exclusively to the classification of high-risk AI systems. Further guidance from the Commission will follow, as indicated in the list of forthcoming guidelines published under: Supporting the .implementation of the AI Act with clear guidelines | Shaping Europe’s digital future The draft Guidelines are prepared pursuant to Article 6(5) AI Act and focus on the rules for the high-risk classification. It is further required that these draft Guidelines should be accompanied with a comprehensive list of practical examples of use-cases of AI systems that are high-risk and not high-risk. These draft Guidelines take into account the outcome of a stakeholder consultation organised by the Commission in June-July 2025 and input provided by the Member States in the context of the European Artificial Intelligence Board (‘AI Board’).  In addition to the written consultation process, the AI Office organised a series of targeted stakeholder workshops in December 2025 in order to gather further practical and sector-specific feedback on the draft Guidelines. To complement these discussions and ensure the inclusion of a broad range of stakeholders, including representatives from industry, academia, civil society, public authorities and other relevant organisations, the AI Office also circulated a follow-up questionnaire aimed at collecting additional written input on specific aspects of the high-risk classification framework and its practical application. On the basis of this input, the Commission prepared the draft guidelines which are now open for stakeholder feedback. This second consultation accompanies the draft Guidelines on the classification of high-risk AI systems under Article 6 AI Act that aim to support consistent interpretation and effective implementation of the AI Act classification rules for high-risk AI systems across the EU. This consultation seeks to collect targeted feedback on the clarity, completeness and practical usability of the draft Guidelines prepared by the Commission based on broad stakeholder input. In particular, the Commission seeks feedback on whether the explanations, methodologies and examples provided sufficiently support stakeholders in determining whether an AI system qualifies as high-risk under the AI Act. The draft Guidelines address the classification of high-risk AI systems in accordance with Article 6 AI Act and are structured as follows: https://digital-strategy.ec.europa.eu/en/news/supporting-implementation-ai-act-clear-guidelines https://digital-strategy.ec.europa.eu/en/news/supporting-implementation-ai-act-clear-guidelines 3 Section I presents an introduction outlining the purpose, scope and legal context of the draft Guidelines. It recalls the objectives and risk-based structure of the AI Act, situates the concept of high- risk AI systems within that framework, and explains the legal basis and role of the draft Guidelines pursuant to Article 6(5) AI Act. Section II sets out general principles for the classification of high-risk AI systems, including the requirement that the system qualifies as an AI system and the role of the intended purpose for its classification. Section III explains the classification of high-risk AI systems under Article 6(1) AI Act and Annex I, including the key elements (such as the notion of a safety component and third-party conformity assessment). Section IV addresses the classification of high-risk AI systems under Article 6(2) AI Act and Annex III, including: horizontal issues applicable across Annex III use cases (such as human involvement, the “intended to be used” criterion, and the interaction with national and EU law); the application of the filter mechanism under Article 6(3) AI Act, including its conditions, exceptions, and safeguards; detailed guidance on each high-risk use case listed under the eight areas in Annex III (biometrics; critical infrastructure; education and vocational training; employment; access to essential private and public services; law enforcement; migration, asylum and border control management; and administration of justice and democratic processes). Section V explains the transitional and grandfathering provisions of the AI Act, clarifying the entry into application of the high-risk AI system requirements and the conditions under which AI systems placed on the market or put into service before the relevant application dates remain subject to the new obligations. All participants are invited to provide feedback on the particular sections of the draft Guidelines they are interested in. In particular, respondents are encouraged to focus on: 4 whether specific sections or subsections require further clarification or refinement to ensure effective implementation and compliance; and whether additional or current examples or use-cases should be included or excluded, taking into account the legal provisions of the AI Act. The feedback collected through this consultation will support the Commission in refining and finalising the draft Guidelines, with the objective of ensuring they are clear, comprehensive, and practically useful for all stakeholders involved in the development, deployment and supervision of AI systems under the AI Act. As not all sections may be relevant for all stakeholders, respondents may reply only to the section(s) they would like. Respondents are encouraged to provide as part of theirexplanations and practical cases responses to support the practical usefulness of the draft Guidelines. We kindly ask that the respondents to specify the exact section and paragraph of the draft Guidelines to which their comments refer. The consultation also aims to collect input for the annual review of the list of prohibitions (Article 5 AI Act) and the high-risk use cases in Annex III AI Act to inform the Commission review pursuant to Article 112(1) AI Act.  The targeted consultation is available in and will be English only open for 5 weeks starting on 19 May .until 23 June 2026 (22:00 CET) All contributions to this consultation may be made publicly available. Therefore, please do not share any personal or confidential information in your contribution (your written feedback). It is your responsibility to avoid personal data and any reference in your written feedback itself that would reveal your identity.   For information on how the Commission processes your personal data please read our Privacy Statement 20250122_Public_Consultation_classification_of_high-risk_AI_systems_PrivacyStatement.pdf Information about the respondent First name Surname * * https://ec.europa.eu/eusurvey/files/4f7ccc9c-1c75-47b1-b5cd-d91c30464349/66e341c7-3699-48d2-996e-32f4bf3e49db 5 Email address Do you agree that we may publish your identity together with your contribution in the instance that all contributions are made publicly available? All contributions to this consultation may be made publicly available. YouIf you act in your personal capacity: can choose whether you would like your details to be made public or to remain anonymous. The respondent category that you selected for this consultation, your answer regarding residence, and your contribution may be published as received. Should you choose to remain anonymous, your name will not be published. Please do not include any personal data in the contribution itself.  All contributions to this consultation may be made publicly available.If you represent one or more organisations: You can choose whether you would like respondent details to be made public or to remain anonymous. Only the following organisation details may be published: The respondent category that you selected for this consultation, the name of the organisation on whose behalf you reply as well as its size, its presence in or outside the EU and your contribution as received. Should you choose to remain anonymous, your name will not be published. Please do not include any personal data in the contribution itself if you want to remain anonymous.  Yes No Do you agree that we may contact you in the event of follow-up questions or if we want to learn more about your responses? Yes No Do you represent an organisation (e.g., a public organisation, a company, a think tank or a civil society /consumer organisation) or act in your personal capacity (e.g., independent expert)? Organisation In a personal capacity If you are representing an organisation, please specify the name of the organisation: Type of organisation Think tank University Research Institute Civil society organisation/association Consumer organisation Company Association * * * * * * 6 Other Is a representation of the organisation located in the EU? The organisation's headquarter is located in the EU A branch office, or any representation of the organisation is located in the EU None of the representations of the organisation is located in the EU Select the EU Member State where the organisation's headquarter, or representation is located AT - Austria BE - Belgium BG - Bulgaria HR - Croatia CY - Cyprus CZ - Czechia DK - Denmark EE - Estonia FI - Finland FR - France DE - Germany EL - Greece HU - Hungary IE - Ireland IT - Italy LV - Latvia LT - Lithuania LU - Luxembourg MT - Malta NL - Netherlands PL - Poland PT - Portugal RO - Romania SK - Slovak Republic SI - Slovenia ES - Spain SE - Sweden Select the country where the organisation's headquarter is located AF - Afghanistan AL - Albania DZ - Algeria AD - Andorra AO - Angola * * * 7 AG - Antigua and Barbuda AR - Argentina AM - Armenia AU - Australia AT - Austria AZ - Azerbaijan BS - Bahamas BH - Bahrain BD - Bangladesh BB - Barbados BY - Belarus BE - Belgium BZ - Belize BJ - Benin BT - Bhutan BO - Bolivia BA - Bosnia and Herzegovina BW - Botswana BR - Brazil BN - Brunei Darussalam BG - Bulgaria BF - Burkina Faso BI - Burundi CV - Cabo Verde KH - Cambodia CM - Cameroon CA - Canada CF - Central African Republic TD - Chad CL - Chile CN - China CO - Colombia KM - Comoros CG - Congo CR - Costa Rica CI - Côte D'Ivoire HR - Croatia CU - Cuba CY - Cyprus CZ - Czechia CD - Democratic Republic of the Congo DK - Denmark 8 DJ - Djibouti DM - Dominica DO - Dominican Republic EC - Ecuador EG - Egypt SV - El Salvador GQ - Equatorial Guinea ER - Eritrea EE - Estonia SZ - Eswatini ET - Ethiopia FJ - Fiji FI - Finland FR - France GA - Gabon GM - Gambia GE - Georgia DE - Germany GH - Ghana GR - Greece GD - Grenada GT - Guatemala GN - Guinea GW - Guinea Bissau GY - Guyana HT - Haiti HN - Honduras HU - Hungary IS - Iceland IN - India ID - Indonesia IR - Iran IQ - Iraq IE - Ireland IL - Israel IT - Italy JM - Jamaica JP - Japan JO - Jordan KZ - Kazakhstan KE - Kenya KI - Kiribati 9 KW - Kuwait KG - Kyrgyzstan LA - Laos LV - Latvia LB - Lebanon LS - Lesotho LR - Liberia LY - Libya LI - Liechtenstein LT - Lithuania LU - Luxembourg MG - Madagascar MW - Malawi MY - Malaysia MV - Maldives ML - Mali MT - Malta MH - Marshall Islands MR - Mauritania MU - Mauritius MX - Mexico FM - Micronesia MC - Monaco MN - Mongolia ME - Montenegro MA - Morocco MZ - Mozambique MM - Myanmar NA - Namibia NR - Nauru NP - Nepal NL - Netherlands NZ - New Zealand NI - Nicaragua NE - Niger NG - Nigeria KP - North Korea MK - North Macedonia NO - Norway OM - Oman PK - Pakistan PW - Palau 10 PA - Panama PG - Papua New Guinea PY - Paraguay PE - Peru PH - Philippines PL - Poland PT - Portugal QA - Qatar MD - Republic of Moldova RO - Romania RU - Russian Federation RW - Rwanda KN - Saint Kitts and Nevis LC - Saint Lucia VC - Saint Vincent and the Grenadines WS - Samoa SM - San Marino ST - Sao Tome and Principe SA - Saudi Arabia SN - Senegal RS - Serbia SC - Seychelles SL - Sierra Leone SG - Singapore SK - Slovakia SI - Slovenia SB - Solomon Islands SO - Somalia ZA - South Africa KR - South Korea SS - South Sudan ES - Spain LK - Sri Lanka SD - Sudan SR - Suriname SE - Sweden CH - Switzerland SY - Syrian Arab Republic TJ - Tajikistan TZ - Tanzania TH - Thailand TL - Timor-Leste 11 TG - Togo TO - Tonga TT - Trinidad and Tobago TN - Tunisia TR - Turkey TM - Turkmenistan TV - Tuvalu UG - Uganda UA - Ukraine AE - United Arab Emirates GB - United Kingdom US - United States of America UY - Uruguay UZ - Uzbekistan VU - Vanuatu VE - Venezuela VN - Viet Nam YE - Yemen ZM - Zambia ZW - Zimbabwe Select the size of the organisation Micro (0-9 employees) Small (10-49 employees) Medium (50-249 employees) Small Mid-Cap (250-499 employees) Large (500 or more employees) Othe (e.g. multiple organisations) Select your country of residence AF - Afghanistan AL - Albania DZ - Algeria AD - Andorra AO - Angola AG - Antigua and Barbuda AR - Argentina AM - Armenia AU - Australia AT - Austria AZ - Azerbaijan BS - Bahamas * * 12 BH - Bahrain BD - Bangladesh BB - Barbados BY - Belarus BE - Belgium BZ - Belize BJ - Benin BT - Bhutan BO - Bolivia BA - Bosnia and Herzegovina BW - Botswana BR - Brazil BN - Brunei Darussalam BG - Bulgaria BF - Burkina Faso BI - Burundi CV - Cabo Verde KH - Cambodia CM - Cameroon CA - Canada CF - Central African Republic TD - Chad CL - Chile CN - China CO - Colombia KM - Comoros CG - Congo CR - Costa Rica CI - Côte D'Ivoire HR - Croatia CU - Cuba CY - Cyprus CZ - Czechia CD - Democratic Republic of the Congo DK - Denmark DJ - Djibouti DM - Dominica DO - Dominican Republic EC - Ecuador EG - Egypt SV - El Salvador GQ - Equatorial Guinea 13 ER - Eritrea EE - Estonia SZ - Eswatini ET - Ethiopia FJ - Fiji FI - Finland FR - France GA - Gabon GM - Gambia GE - Georgia DE - Germany GH - Ghana GR - Greece GD - Grenada GT - Guatemala GN - Guinea GW - Guinea Bissau GY - Guyana HT - Haiti HN - Honduras HU - Hungary IS - Iceland IN - India ID - Indonesia IR - Iran IQ - Iraq IE - Ireland IL - Israel IT - Italy JM - Jamaica JP - Japan JO - Jordan KZ - Kazakhstan KE - Kenya KI - Kiribati KW - Kuwait KG - Kyrgyzstan LA - Laos LV - Latvia LB - Lebanon LS - Lesotho LR - Liberia 14 LY - Libya LI - Liechtenstein LT - Lithuania LU - Luxembourg MG - Madagascar MW - Malawi MY - Malaysia MV - Maldives ML - Mali MT - Malta MH - Marshall Islands MR - Mauritania MU - Mauritius MX - Mexico FM - Micronesia MC - Monaco MN - Mongolia ME - Montenegro MA - Morocco MZ - Mozambique MM - Myanmar NA - Namibia NR - Nauru NP - Nepal NL - Netherlands NZ - New Zealand NI - Nicaragua NE - Niger NG - Nigeria KP - North Korea MK - North Macedonia NO - Norway OM - Oman PK - Pakistan PW - Palau PA - Panama PG - Papua New Guinea PY - Paraguay PE - Peru PH - Philippines PL - Poland PT - Portugal 15 QA - Qatar MD - Republic of Moldova RO - Romania RU - Russian Federation RW - Rwanda KN - Saint Kitts and Nevis LC - Saint Lucia VC - Saint Vincent and the Grenadines WS - Samoa SM - San Marino ST - Sao Tome and Principe SA - Saudi Arabia SN - Senegal RS - Serbia SC - Seychelles SL - Sierra Leone SG - Singapore SK - Slovakia SI - Slovenia SB - Solomon Islands SO - Somalia ZA - South Africa KR - South Korea SS - South Sudan ES - Spain LK - Sri Lanka SD - Sudan SR - Suriname SE - Sweden CH - Switzerland SY - Syrian Arab Republic TJ - Tajikistan TZ - Tanzania TH - Thailand TL - Timor-Leste TG - Togo TO - Tonga TT - Trinidad and Tobago TN - Tunisia TR - Türkiye TM - Turkmenistan TV - Tuvalu 16 UG - Uganda UA - Ukraine AE - United Arab Emirates GB - United Kingdom US - United States of America UY - Uruguay UZ - Uzbekistan VU - Vanuatu VE - Venezuela VN - Viet Nam YE - Yemen ZM - Zambia ZW - Zimbabwe Which stakeholder category would you consider yourself in? If more than one category is applicable, please select the category that is best applicable in your situation / from the capacity you are responding. Deployer of an AI system Provider of an AI system Other operators Other independent expert or organisation with relevant expertise Civil society organisation Supervisory authority Business association Academia Other Please, specify Sector(s) of activity Information technology Employment Transport Public administration Education and training Telecommunications Law enforcement Consumer services Retail Justice sector Business services E-commerce Legal services sector Banking and finances Advertising Cultural and creative sector, including media Manufacturing Consumer protection Healthcare Energy Others Please, specify 30 character(s) maximum * * * * 17 Describe the activities of your organisation or yourself 1300 character(s) maximum On which part(s) of the draft Guidelines would like comment? Multiple answers are possible. Please note that selecting a particular answer will direct you to a set of questions specifically related to subject specified. General principles for classification of high-risk AI systems under Article 6. (Section II) High-risk classification according to Article 6(1) – Annex I. (Section III) High-risk classification according to Article 6(2) – Annex III. (Section IV) Questions in relation to Article 112 paragraph 1 (Evaluation and Review) General principles for classification of high-risk AI systems under Article 6 (Section II of the draft Guidelines) Select the relevant subsection(s): II.1 The system must be an AI system II.2 Intended purpose(s) of the AI system II.1 The system must be an AI system Are there any aspects / paragraphs of this Section of the draft Guidelines that you believe require Question A. further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Please indicate specific parts of the draft Guidelines (i.e., paragraph(s) number).   1500 character(s) maximum II.2 Intended purpose(s) of the AI system Are there any aspects / paragraphs of this Section of the draft Guidelines that you believe require Question A. further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Please indicate specific parts of the draft Guidelines (i.e., paragraph(s) number).   1500 character(s) maximum * * 18 High-risk classification according to Article 6(1) – Annex I (Section III of the draft Guidelines) Select the relevant subsection(s): III.1 The rationale III.2 Main elements for classification as high-risk Select the relevant subsection(s) III.2.1 Component of a product or itself a product III.2.2 Safety component III.2.3 Third-party conformity assessment III.1 The rationale Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A 19 Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed 20 Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you think there are additional examples or use-cases , relevant for this Section of the draft Question B. Guidelines, that you find important that the Guidelines include or exclude from the scope of high-risk classification, taking into account the legal provisions in the AI Act? Yes No N/A If so: a) please explain why do you think they should be treated as such and b) if your suggested example(s) or use case(s) are to be considered as in or out of scope. 2000 character(s) maximum III.2 Main elements for classification as high-risk 21 Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No 22 Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No 23 Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you think there are additional examples or use-cases , relevant for this Section of the draft Question B. Guidelines, that you find important that the Guidelines include or exclude from the scope of high-risk classification, taking into account the legal provisions in the AI Act? If so, please explain why you think they should be treated as such, in order to help the Commission refine the draft Guidelines and ensure they are comprehensive. Yes No N/A If so: a) please explain why do you think they should be treated as such and b) if your suggested example(s) or use case(s) are to be considered as in or out of scope. 2500 character(s) maximum III.2.1 Component of a product or itself a product Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed 24 Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed 25 Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum 26 Do you think there are additional examples or use-cases , relevant for this Section of the draft Question B. Guidelines, that you find important that the Guidelines include or exclude from the scope of high-risk classification, taking into account the legal provisions in the AI Act? Yes No N/A If so: a) please explain why do you think they should be treated as such and b) if your suggested example(s) or use case(s) are to be considered as in or out of scope. 2500 character(s) maximum III.2.2 Safety component Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No 27 N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A 28 Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you think there are additional examples or use-cases , relevant for this Section of the draft Question B. Guidelines, that you find important that the Guidelines include or exclude from the scope of high-risk classification, taking into account the legal provisions in the AI Act? Yes No N/A If so: a) please explain why do you think they should be treated as such and b) if your suggested example(s) or use case(s) are to be considered as in or out of scope. 2500 character(s) maximum 29 III.2.3 Third-party conformity assessment Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No 30 Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No 31 Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you think there are additional examples or use-cases , relevant for this Section of the draft Question B. Guidelines, that you find important that the Guidelines include or exclude from the scope of high-risk classification, taking into account the legal provisions in the AI Act? Yes No N/A If so: a) please explain why do you think they should be treated as such and b) if your suggested example(s) or use case(s) are to be considered as in or out of scope. 2500 character(s) maximum High-risk classification according to Article 6(2) – Annex III (Section IV of the draft Guidelines) Select the relevant subsection(s): IV.1 Rationale and approach IV.2 Horizontal issues applicable to Annex III use cases IV.3 High-risk AI systems in the areas of Annex III IV.1 Rationale and approach 32 Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No 33 Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No 34 Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you think there are additional examples or use-cases , relevant for this Section of the draft Question B. Guidelines, that you find important that the Guidelines include or exclude from the scope of high-risk classification, taking into account the legal provisions in the AI Act? If so, please explain why you think they should be treated as such, in order to help the Commission refine the draft Guidelines and ensure they are comprehensive. Yes No N/A Please specify: 2500 character(s) maximum IV.2 Horizontal issues applicable to Annex III use cases Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed 35 Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum 36 Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum 37 Do you think there are additional examples or use-cases , relevant for this Section of the draft Question B. Guidelines, that you find important that the Guidelines include or exclude from the scope of high-risk classification, taking into account the legal provisions in the AI Act? Yes No N/A If so: a) please explain why do you think they should be treated as such and b) if your suggested example(s) or use case(s) are to be considered as in or out of scope. 3000 character(s) maximum IV.3 High-risk AI systems in the areas of Annex III Please select the sector(s) you wish to comment on. Multiple answers are possible 3.1 Biometrics 3.2 Critical infrastructure 3.3 Education and vocational training 3.4 Employment, workers’ management and access to self-employment 3.5 Access to and enjoyment of essential private services and essential public services and benefits 3.6 Law enforcement 3.7 Migration, asylum and border control management 3.8 Administration of justice and democratic processes 3.1 Biometrics Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum 38 Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? 39 Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you think there are additional examples or use-cases , relevant for this Section of the draft Question B. Guidelines, that you find important that the Guidelines include or exclude from the scope of high-risk classification, taking into account the legal provisions in the AI Act? 40 Yes No N/A If so: a) please explain why do you think they should be treated as such and b) if your suggested example(s) or use case(s) are to be considered as in or out of scope. 2500 character(s) maximum 3.2 Critical infrastructure Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed 41 Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 42 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you think there are additional examples or use-cases , relevant for this Section of the draft Question B. Guidelines, that you find important that the Guidelines include or exclude from the scope of high-risk classification, taking into account the legal provisions in the AI Act? Yes No N/A If so: a) please explain why do you think they should be treated as such and b) if your suggested example(s) or use case(s) are to be considered as in or out of scope. 2500 character(s) maximum 3.3 Education and vocational training Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? 43 Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No 44 N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A 45 Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you think there are additional examples or use-cases , relevant for this Section of the draft Question B. Guidelines, that you find important that the Guidelines include or exclude from the scope of high-risk classification, taking into account the legal provisions in the AI Act? If so, please explain why you think they should be treated as such, in order to help the Commission refine the draft Guidelines and ensure they are comprehensive. Yes No N/A If so: a) please explain why do you think they should be treated as such and b) if your suggested example(s) or use case(s) are to be considered as in or out of scope. 2500 character(s) maximum 3.4 Employment Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum 46 Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes 47 No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you think there are additional examples or use-cases , relevant for this Section of the draft Question B. Guidelines, that you find important that the Guidelines include or exclude from the scope of high-risk classification, taking into account the legal provisions in the AI Act? Yes 48 No N/A If so: a) please explain why do you think they should be treated as such and b) if your suggested example(s) or use case(s) are to be considered as in or out of scope. 2500 character(s) maximum 3.5 Access to and enjoyment of essential services and benefits3.4 Employment Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed 49 Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum 50 Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you think there are additional examples or use-cases , relevant for this Section of the draft Question B. Guidelines, that you find important that the Guidelines include or exclude from the scope of high-risk classification, taking into account the legal provisions in the AI Act? Yes No N/A If so: a) please explain why do you think they should be treated as such and b) if your suggested example(s) or use case(s) are to be considered as in or out of scope. 2500 character(s) maximum 3.6 Law enforcement Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No 51 NA Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A 52 Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed 53 Please specify 500 character(s) maximum Do you think there are additional examples or use-cases , relevant for this Section of the draft Question B. Guidelines, that you find important that the Guidelines include or exclude from the scope of high-risk classification, taking into account the legal provisions in the AI Act? Yes No N/A If so: a) please explain why do you think they should be treated as such and b) if your suggested example(s) or use case(s) are to be considered as in or out of scope. 2500 character(s) maximum 3.7 Migration, asylum and border control management Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Please indicate specific parts of the draft Guidelines (i.e., Section/subsection /paragraph(s) number). Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No 54 Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No 55 Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you think there are additional examples or use-cases , relevant for this Section of the draft Question B. Guidelines, that you find important that the Guidelines include or exclude from the scope of high-risk classification, taking into account the legal provisions in the AI Act? Yes No N/A 56 If so: a) please explain why do you think they should be treated as such and b) if your suggested example(s) or use case(s) are to be considered as in or out of scope. 2500 character(s) maximum 3.8 Administration of justice and democratic processes Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum 57 Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum 58 Do you have more suggestions? Yes No Are there any aspects / sections / paragraphs of this Section of the draft Guidelines that you Question A. believe require further clarification, and if so, how would you suggest they be improved to ensure effective implementation and compliance? Yes No N/A Relevant paragraph number Only values of at most 1000 are allowed Please specify 500 character(s) maximum Do you think there are additional examples or use-cases , relevant for this Section of the draft Question B. Guidelines, that you find important that the Guidelines include or exclude from the scope of high-risk classification, taking into account the legal provisions in the AI Act? Yes No N/A If so: a) please explain why do you think they should be treated as such and b) if your suggested example(s) or use case(s) are to be considered as in or out of scope. 2500 character(s) maximum Questions in relation to Article 112 paragraph 1 (Evaluation and Review) Under Article 112(1) AI Act, the Commission is tasked with annually assessing the need to amend the list of high-risk AI systems set out in Annex III AI Act and the list of prohibited AI practices laid down in Article 5 AI Act. In this context, the Commission aims to gather insights from a wide range of stakeholders and invites you to share your views on whether amendments to the list of prohibited practices and the high-risk use cases in Annex III are needed. 59 Are you aware of concrete use cases of AI systems that in your opinion need to be added to the Question 1. list of use cases in Annex III - within the existing 8 areas - to ensure that all AI systems having equivalent risk of harm (in accordance with the criteria laid down pursuant to Article 7(2) AI Act) are classified as high-risk under the Annex III AI Act? Yes No Not applicable If yes, please specify why you consider that this use case(s) should be classified as high-risk taking into account the criteria in Article 7(2) and provide evidence that justify such a change. 1500 character(s) maximum Do you consider that some of the existing use cases listed in Annex III AI Act need to be Question 2. amended in order to fulfil the conditions laid down pursuant to Article 7(2) AI Act? Yes No Not applicable If yes, please specify your arguments and provide evidence that justify such a change. 1500 character(s) maximum Do you consider that some of the existing use cases listed in Annex III AI Act should be removed, Question 3. since they do not pose anymore equivalent risk of harm (in accordance with the criteria laid down pursuant to Article 7(2) AI Act)? Yes No Not applicable If yes, please specify your arguments and provide evidence that justify such a change. 1500 character(s) maximum Do you consider that the list of prohibited AI practices in Article 5 should be expanded? In Question 4. particular, are there concrete examples of AI practices that, in your view, conflict with Union values and are not yet adequately addressed by the AI Act or other Union legislation? Yes No Not applicable 60 If yes, please specify your arguments and provide evidence that justify such a change. 1500 character(s) maximum Do you consider that some of the prohibitions listed in Article 5 AI Act are already sufficiently Question 5. addressed by other Union legislation and should therefore be removed from the list of prohibited practices in Article 5 AI Act? Yes No Not applicable If yes, please specify your arguments and provide evidence that justify such a change.   1500 character(s) maximum

Artikel 6 der Verordnung (EU) 2024/1689 über Künstliche Intelligenz definiert die Kategorie der Hochrisiko-KI-Systeme. Ein KI-System gilt demnach als hochriskant, wenn zwei Voraussetzungen erfüllt sind. Erstens muss das KI-System als Sicherheitsbauteil eines Produkts eingesetzt werden, das unter die in Anhang I aufgeführten Harmonisierungsrechtsvorschriften der Union fällt, oder selbst ein solches Produkt darstellen. Zweitens muss dieses Produkt oder das KI-System selbst im Hinblick auf das Inverkehrbringen oder die Inbetriebnahme einer Konformitätsbewertung durch Dritte gemäß diesen Vorschriften unterzogen werden. KI-basierte Medizinprodukte, für die ein Konformitätsbewertungsverfahren unter Einbeziehung einer Benannten Stelle erforderlich ist, fallen somit unter die Definition von Hochrisiko-KI-Systemen. Vor diesem Hintergrund hat die Europäische Kommission Leitlinien erarbeitet, die Anbieter, Betreiber und weitere relevante Akteure bei der Einordnung von KI-Systemen unterstützen sollen. Die Leitlinien erläutern die maßgeblichen Bestimmungen der KI-Verordnung und enthalten praxisnahe Beispiele, um die Anwendung in unterschiedlichen Anwendungsbereichen zu veranschaulichen. Bis zum 23. Juni 2026 besteht die Möglichkeit, zum Entwurf dieser Leitlinien Stellung zu nehmen. Die gezielte Konsultation richtet sich an alle interessierten Kreise, darunter KI-Anbieter und -Entwickler, Anwenderorganisationen, Behörden, Forschungseinrichtungen sowie zivilgesellschaftliche Organisationen. Die Fragen zur Konsultation sind in einem begleitenden PDF-Dokument aufgeführt. Es werden ausschließlich Rückmeldungen berücksichtigt, die über den vorgesehenen Online-Fragebogen eingereicht werden.

Die vier Trägerorganisationen des G-BA — GKV-Spitzenverband, KBV, KZBV und Deutsche Krankenhausgesellschaft — hatten sich zuvor auf Optendrenk verständigt, und das Bundesgesundheitsministerium informierte den Ausschuss offiziell über die Nominierung. Optendrenk, eine ausgewiesene Kennerin des deutschen Gesundheitssystems, tritt die Nachfolge von Josef Hecken an. Hecken führte seit Juli 2012 den G-BA , und scheidet - wie schon länger bekannt war - zum 30. Juni aus; Optendrenk wird Anfang Juli die Position übernehmen. Aktuell - seit Anfang 2024 - ist Optendrenk Staatssekretärin im Hessischen Ministerium für Familie, Senioren, Sport, Gesundheit und Pflege. Zuvor war sie von 2002 bis 2024 im Bundesgesundheitsministerium tätig, mit einer Unterbrechung, während der sie im Bundeskanzleramt mit Gesundheitspolitik befasst war. Pharma Deutschland wird zeitnah den Dialog mit der neuen Vorsitzenden suchen.

Unsere Regionalbeauftragte Nicole Westig war zu Gast im niederrheinischen Tönisvorst bei unserem Mitglied action medeor e.V. – dem international als „Notapotheke der Welt“ bekannten Medikamenten-Hilfswerk. „Kein Mensch soll an einer behandelbaren Krankheit sterben müssen“ – diese Vision verfolgte der Hausarzt Dr. Ernst Boekels, als er action medeor vor mehr als 60 Jahren gründete. Bis heute prägt dieser Anspruch die Arbeit der Organisation. Weltweit leistet action medeor einen kontinuierlichen und entscheidenden Beitrag, um den Zugang zu lebenswichtigen Arzneimitteln zu verbessern – sei es in Entwicklungs- und Schwellenländern oder in Krisen- und Katastrophengebieten. Dabei geht das Engagement weit über die reine Medikamentenversorgung hinaus. Neben der Bereitstellung von Arzneimitteln und medizinischer Ausrüstung unterstützt action medeor den Aufbau von Gesundheitsstationen und Apotheken vor Ort sowie die Schulung von medizinischem Personal. Ziel ist es, nachhaltige Strukturen zu schaffen und die Gesundheitsversorgung langfristig zu stärken. Vorständin Dr. Angela Zeithammer und Julia Ramisch, verantwortlich für Unternehmenskooperationen, führten durch die Organisation und gaben umfassende Einblicke in ihre Arbeit. Besonders eindrucksvoll war das große Zentrallager, von dem aus allein im Jahr 2024 mehr als 18.400 Pakete in 38 Länder versendet wurden. Durch die Kombination aus Spenden, gezieltem Einkauf und logistischer Expertise gelingt es action medeor, flexibel und schnell auf unterschiedlichste Bedarfe zu reagieren. Für pharmazeutische Unternehmen ergeben sich hier konkrete Anknüpfungspunkte, um Verantwortung zu übernehmen und ihre Expertise einzubringen. Zahlreiche Unternehmen engagieren sich bereits – und tragen gemeinsam dazu bei, dass Hilfe dort ankommt, wo sie dringend benötigt wird. Pharma Deutschland macht gerne auf diese wertvolle Arbeit aufmerksam, um weitere Kooperationen zu stärken und auszubauen.