TIMELINES AND COMPLIANCE: THE NEW REGULATORY LANDSCAPE
The Implementing Act mandates compliance with pre-agreed timelines for the assessment activities required for certification. For manufacturers, this poses a concrete risk of failing to demonstrate compliance within the set deadlines. Should these timelines be exceeded or the maximum number of revisions be reached, specific agreements must be established to proceed with the process. In parallel, a guidance document drafted by the NBCG-Med regarding “Changes” is currently being evaluated by the NBO; this document aims to clarify manufacturers’ reporting obligations and the assessment activities to be carried out by Notified Bodies.
THE MDR 2.0 REVOLUTION
The Commission calls for the adoption of a regulation to govern the matter by the end of the year.
The objective is ambitious: to streamline certification processes without compromising safety. Within this context, key discussion points included reduced sampling of technical documentation and the audit frequency changing from once every 12 months to once every two years.
CONCERNS OF THE NOTIFIED BODIES
Despite the simplifications, Notified Bodies are expressing strong concerns. On one hand, there is the fear of reduced surveillance assessments by NBs; on the other, the economic impact. The obligation to apply discounts between 25% and 50% to micro, small, and medium-sized enterprises (SMEs)—which form the backbone of the EU market—combined with the potential imposition of maximum fee scales by the Commission and rising insurance costs, risks destabilizing the financial health of certification bodies.
The meeting therefore reaffirmed the central importance of the MDR for patient safety and industry competitiveness, while simultaneously highlighting the need to address current operational challenges with an eye toward upcoming regulatory changes.
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