EU parliament decides to postpone the MDR, again
The European Parliament has definitively approved the proposals of the European Commission and the Council of the European Union by validating the postponements of the medical devices regulation (MDR) to :
- 31 December 2027 for class III and IIb implantable devices;
- 31 December 2028 for class II and class I products requiring a notified body;
- May 26, 2026 for class III custom-made implants.
With 15 months to go before the full entry into force of Regulation (EU) 2017/745 (MDR), the European negotiations have taken note of the mathematical impossibility for the notified bodies to study the 22,793 medical device dossiers in time, and thus to affix the precious "CE Marking" sesame. With an annual capacity of 6,300, it would have taken them 44 months, or almost 3.5 years, to do so.