The regulatory landscape for medical devices in Europe is undergoing a period of profound transformation. Recent proposals to revise Regulation (EU) 2017/745 (MDR) aim to introduce greater predictability, transparency, and efficiency into conformity assessment procedures—objectives that are widely supported by Notified Bodies (NBs). However, the enthusiasm for bureaucratic simplification is accompanied by serious reflections on the overall resilience of the system.

CRITICAL ISSUES OF THE NEW FRAMEWORK

While process optimization is necessary, Team-NB and prominent organizations like Ente Certificazione Macchine (ECM) raise concerns regarding a potential reduction in oversight levels. The risk is that weakening surveillance could drive safety standards below those guaranteed by the former Directives, undermining patient trust and the integrity of market oversight.

Another contentious point concerns the Commission’s economic impact assessment. In the eyes of experts, the estimated savings appear to be based on unrealistic assumptions that do not reflect the actual scale of Notified Bodies’ revenues.

TOWARDS A SUSTAINABLE REGULATORY FRAMEWORK

Support for measures that reduce administrative burden and foster innovation remains steadfast. The key to the reform’s success lies in:

• Early Dialogue: Facilitating engagement between manufacturers and regulators;

• Operational Efficiency: Streamlining procedures without compromising technical rigor;

• Safeguarding Health: Maintaining patient safety as a central pillar.

In conclusion, institutions such as ECM, in alignment with Team-NB’s positions, reiterate that every regulatory evolution must promote the competitiveness of European companies without ever sacrificing the robust surveillance mechanisms that guarantee the excellence of medical devices placed on the market.