Team-NB raises concerns over proposed MDR and IVDR revisions
The European Association of Medical Devices Notified Bodies (Team-NB) has published a position paper on the European Commission’s proposed targeted revisions to Regulation (EU) 2017/745 (Medical Device Regulation (MDR)) and Regulation (EU) 2017/746 (In Vitro Diagnostic Medical Devices Regulation (IVDR)). Team-NB supports measures aimed at improving predictability, transparency and efficiency in conformity assessment, and acknowledges that the MDR and IVDR have strengthened quality, clinical evidence and regulatory compliance across the sector. However, it notes that key initiatives, including the European Database on Medical Devices (EUDAMED) and the development of Common Specifications, remain incomplete and states that any further reforms should be evidence-based, realistic and implemented in a way that supports rather than disrupts the existing system. It also questions the Commission’s estimate of €2.1bn in conformity assessment savings, arguing that total notified body revenue in 2024 amounted to €475m, representing only a small proportion of the €170bn EU MedTech market. The paper further identifies positive elements in the proposal, such as increased digitalisation, strengthened regulatory dialogue and measures designed to facilitate innovation. It also addresses the proposed mandatory fee discounts for micro and small manufacturers, citing survey data indicating that 54% of such manufacturers placing devices on the EU market are based outside the EU, and outlining the potential implications for notified body revenues and broader market dynamics.