On 18 May 2026, the European Medicines Agency (EMA) published a summary of discussions from its second workshop bringing together expert panels and notified bodies, focusing on improving the consistency and quality of medical device assessments under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The workshop, which involved representatives from expert panels, notified bodies, and the European Commission, addressed challenges in the classification, clinical evaluation, and post-market surveillance of devices, with the aim of streamlining the conformity assessment process and ensuring patient safety.
The document, titled 'Highlights from the second expert panels and notified bodies workshop,' outlines key topics such as the role of expert panels in providing scientific advice, the harmonisation of clinical evaluation assessment procedures, and the handling of devices with novel technologies. Participants discussed the need for clearer guidance on the application of the MDR and IVDR, particularly for devices that fall under the scope of the expert panels' scrutiny. The workshop also examined the interface between notified bodies and expert panels, emphasising the importance of early dialogue to avoid delays in certification.
Policy orientations and trade-offs
The workshop highlighted a tension between the desire for rigorous, harmonised assessments and the need to maintain timely access to innovative medical devices. Stricter requirements could enhance patient safety but may increase the administrative burden on manufacturers and slow down market access. Conversely, more flexible approaches could speed up approvals but risk inconsistent evaluations across member states. Participants called for better alignment of notified body practices and more detailed guidance from the European Commission to reduce variability.
Impact on stakeholders
Medical device manufacturers face potential increases in compliance costs and longer timelines for certification if expert panels expand their scrutiny. Notified bodies may need to invest in additional expertise and training to meet harmonised standards. Healthcare providers and patients stand to benefit from more consistent safety and performance assessments, though delays in market entry could limit access to innovative treatments. The European Commission is expected to use the workshop outcomes to refine its guidance documents and possibly propose regulatory adjustments.
Expected institutional follow-up
The EMA plans to continue the dialogue through future workshops and to feed the discussions into the work of the Medical Device Coordination Group (MDCG). The European Commission may issue updated guidance on clinical evaluation and post-market surveillance based on the workshop's recommendations. The next steps include the publication of a more detailed report and the development of training materials for notified bodies and expert panels.