Today the EU Commission updated the MDR Transition Extension Q&A. The updated version is available: HERE
The Q&A provides practical guidance on how to apply the MDR extension under EU Regulation 2023/607. For example:
- How does a manufacturer show proof that they have met the requirement to implement an MDR-compliant QMS by 26 May 2024?
- Which classification determines the transition period deadline – the current MDD/AIMDD classification or the new MDR classification?