COCIR, together with 17 other European business associations, has sent an open letter to the Portuguese Presidency of the Council regarding their concerns regarding the European Commission’s over-prescriptive approach to EU harmonised standards and their treatment of standards as an “extension of EU law” rather than a market-driven implementation tool.

With the transition from the Medical Device Directives to the MDR and the resulting need for newly harmonized standards, this is an especially urgent topic for the medical devices sector. Timely and effective harmonised standardisation in the EU is crucial for industry competitiveness.