ARTICLE SUMMARY:
Device companies complain about a lack of consistency in how notified bodies carry out EU device and diagnostics requirements, but the bodies have increasingly tried to present a unified voice via their trade association, Team NB. That effort was evident in three documents posted by TEAM-NB last month.
Docs of the Month is a regular column highlighting key findings from Pathways’ Document Depot, a database of global medtech regulatory and policy official documents, including rules, guidances, memos, white papers, and more from national authorities, non-governmental groups, and global organizations.
The promise of EU-wide regulations like the Medical Device and IVD Regulation (MDR/IVDR) is there is one set of rules—a product can pass muster in any country in the Union and be sold throughout. That implies consistent expectations for exactly what a company needs to do to comply and reach the market no matter where in the EU it starts its journey.
Of course, that’s easier said than accomplished. There are 27 different EU member states with national laws that can impact how elements of the MDR/IVDR are implemented. More directly, there are currently 50 different notified bodies that perform conformity assessments for the MDR and 17 that operate under the IVDR. These organizations are bound to come to different conclusions sometimes about how the complex regulatory provisions translate into a particular data or document requirement for a specific device.
Inconsistency and fragmentation in how the regulations are carried out remains a challenge, device companies say. Industry and other stakeholders are calling for stronger centralized governance of the frameworks to ensure more consistency. But notified bodies argue the situation has improved as more organizations scale the steep MDR/IVDR learning curve. One important factor driving the improvements is notified bodies collaborating via TEAM-NB. The organization (named based on an acronym for The European Association of Medical device Notified Bodies) provides a forum for the assessment bodies to talk about experiences with the MDR and IVDR and reach consensus about how to approach the regulations.
