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The European Association of Medical Devices – Notified Bodies

Team-NB

The Association, is a non-profit association, with the objective to represent the European Notified Bodies for Medical Devices in their dealings with all the stakeholders of the sector; namely the European Commission, Competent Authorities of Members States, associations of the medical devices industry and with the media.

Lobbying Activity

Meeting with Olivér Várhelyi (Commissioner) and

18 Nov 2025 · Medical device review

Response to Digital package – digital omnibus

14 Oct 2025

Team NB, as notified bodies association, welcomes the Commission's initiative to drive forward the simplification of the digital regulatory framework and reduce administrative costs for businesses as part of the Digital Omnibus. We strongly support the general objective of creating legal clarity and predictability, especially with regard to the optimal application of the recently adopted AI Regulation (Regulation (EU) 2024/1689). Indeed, notified bodies plays a vital role in ensuring the high level of health, safety, and fundamental rights protection envisioned by the AI Act.
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Response to Targeted revision of the EU rules for medical devices and in vitro diagnostics

6 Oct 2025

Notified bodies (Team-NB and non-Team-NB members)
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Meeting with Lorena Boix Alonso (Deputy Director-General Health and Food Safety) and

31 Jul 2025 · Exchange of views on the state of play and next steps for the medical devices sector.

Response to Health technology assessment - Joint clinical assessments of medical devices and in vitro diagnostic medical devices

25 Jun 2025

TEAM-NB (The European Association of Medical Devices Notified Bodies) represents Notified Bodies (NBs) active in certifying medical devices under EU regulations. We welcome that the Commission acknowledges the confidential nature of medical device conformity assessments as stated in recital 3 of the draft. However, there should not be a new and additional reporting route for the outcomes of these assessments (recital 4 and Art. 4(2)). Assuming this implementing regulation wont enter into force before January 2026, EUDAMED will be operational and include all necessary information for the subsequent JCA procedure. Further, the reason for duplicate reporting as foreseen by this draft remains elusive: health technology developer and notified body are required to submit essentially the same information according to Article 3 (1)(a) and Article 4 (2) respectively. Instead, we propose the deletion of Article 4 and the addition of Article 3 (4), as all necessary information is already to be provided by the manufacturer and may be confirmed via EUDAMED: We propose the following wording for Article 3(4): The information provided by the health technology developer according to paragraphs 1 and 2 of this article shall be verified by the HTA secretariat in EUDAMED (i.e. database acc. to Art. 33, Regulation (EU) 2017/745 and Art. 30 Regulation (EU) 2017/746). By limiting the number of involved parties in this procedure, administrative burden is reduced and more fitting to the foreseen tight timeline of 5 days.
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Response to Apply AI Strategy

4 Jun 2025

TEAM-NB (The European Association of Medical Devices Notified Bodies) is an association representing Notified Bodies (NBs) active in the certification of medical devices under EU regulations. While we fully support the objective of the Artificial Intelligence Act (AIA, Regulation (EU) 2024/1689) to ensure consumer and patient safety, we are increasingly concerned about the pace of implementation. Progress at both EU and national levels is insufficient to meet the deadlines. The AIA will apply to medical devices from 2 August 2027. Without substantial efforts, we foresee major disruption for the MedTech industry, Notified Bodies, and ultimately, European patients. The EU Apply AI Strategy risks falling short unless legislators act pragmatically and in coordination. Drawing from the MDR and IVDR experience, we believe a functional regulatory framework under the AIA is unachievable without extending current transition periods. The designation of NBs was intended to begin on 2 August 2025. However, implementing acts defining key aspects, as requirements for authorised personnel or designating authorities, are still missing. Based on precedent, designating NBs alone takes at least two years, not including the time needed for NBs to prepare and submit applications. Even once NBs are designated, manufacturers will need another year to complete conformity assessments and bring their AI-enabled devices to market. This means, if designation processes begin before August 2026, a minimum three-year extension will be required. Crucially, this timeline does not consider high-risk AI systems under Article 6(2), which must comply by 2 August 2026. These may require even longer transition periods or alternative solutions. These timelines do not fully account for delays due to unclear legal requirements. To enable timely implementation, the AIA must be translated into implementing and delegated acts, guidance, and policies in the most pragmatic way possible: - Under Article 43(3), AIA conformity assessments must be integrated into procedures already established under the MDR and IVDR. This requires expanding NB competencies to cover AIA requirements within existing frameworks. A full redesignation process under Article 30 AIA would be disproportionately time-consuming without providing meaningful benefits in terms of oversight. - Definitions and terminology in the AIA must be clear and consistent. Current guidance on what constitutes an AI system leaves too much room for interpretation, leading to time-consuming debates. Other key terms, such as safety component and substantial modification, still lack any guidance. - Harmonised standards are essential for clarifying technical compliance requirements. However, the development of these standards is significantly delayed and will not align with the AIAs earliest applicability dates for high-risk systems. - Access to high-quality data, such as from the European Health Data Space (EHDS), is vital for NB testing of high-risk AI systems. Since the EHDS framework will not be ready in time for the AIA, interim solutions must be identified to enable adequate NB scrutiny of medical device AI. - Reporting and vigilance obligations under the AIA must align with existing MDR and IVDR provisions. A fragmented approach with duplicate reporting channels risks missing critical safety issues. Seamless integration and data sharing between systems are key to effective oversight. In conclusion, successful implementation of the AIA requires urgent adjustments to timelines and practical guidance. Failure to do so will likely result in regulatory bottlenecks that could compromise innovation, certification capacity, and patient safety across Europe.
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Meeting with Flora Giorgio (Head of Unit Health and Food Safety) and Notified Body Coordination Group - Medical Devices

17 Feb 2025 · Opportunities for the improvement of harmonisation and predictability of conformity assessment procedures under MDR / IVDR. Involvement of Commission representatives during the NBCG-Med plenary meeting planned in April 2025.