A newly published legal expert opinion finds that proposed Article 50 of the MDR Revision would create serious interferences with the freedom to conduct a business under the Charter of Fundamental Rights of the European Union (CFREU), in particular Article 16 CFREU.
The proposed measures—mandatory fee reductions, payment deferral and the possibility for forced acceptance of conformity‑assessment requests —are found to “go beyond what the Charter permits” and not necessary, although the objectives pursued —support for SMEs, innovation, device availability and public health—are legitimate.
The analysis further notes that the proposal uses private notified bodies as the financing mechanism for public‑policy objectives, without compensation or cost‑based safeguards. On this basis, the opinion concludes that Article 50 is disproportionate, violates Article 16 CFREU, and would be invalid and unenforceable if adopted as proposed.