Earlier this month, Advena proudly attended the 10th annual conference of the European Association of Authorised Representatives (EAAR) in Brussels. This important event brought together a diverse group of stakeholders, including members of the European Commission for Medical Devices, Competent Authorities, Notified Bodies, manufacturers, and EAAR members.
The conference provided a valuable platform for discussing key topics shaping the future of medical device regulation in Europe. Among the main points were the ongoing revisions of the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR). Attendees also examined the progress related to the implementation of the EUDAMED database, national registration requirements across member states, and emerging issues such as Software as a Medical Device (SaMD) and the development of artificial intelligence within the medical device sector.
A central theme of the discussions was the pursuit of regulatory simplification. Efforts aim to reduce administrative burdens and reporting obligations, support innovation, and align regulations with other legislative frameworks. Proposed measures include streamlining procedures, enhancing cost-effectiveness of certification processes, and maintaining a strong focus on patient safety. Notably, there was a suggestion to eliminate re-certification and surveillance for certain device types based on risk, with sampling of technical files after initial assessment focusing on new designs or risk information to minimize re-assessment requirements.
Further proposals addressed the classification of Software as a Medical Device, advocating for a clearer approach to prevent divergent interpretations. This includes revising Rule 11 to align software classification with actual clinical risk, thereby avoiding automatic classifications that may not accurately reflect device risk profiles.
Another key discussion point was the digitalization of submission and assessment processes. The Notified Bodies’ DigiCAP initiative, scheduled for September, aims to digitalize the conformity assessment process. This will coincide with an expert panel review on digital pathways for medical device innovations, fostering a more streamlined and efficient regulatory environment.
Overall, the discussions among stakeholders suggest a positive outlook for the medical device and in-vitro diagnostic sectors. Although the European Commission’s plenary vote on the proposed revisions is scheduled for January/February 2027, we remain optimistic and look forward to seeing the adoption of a unified, simplified regulatory approach that reduces administrative burdens while maintaining high safety standards. Below is a snap from the event.
