The MDCG published a new Position Paper on continued access to the market under MDR Article 97, after an MDD/AIMDD CE certificate expires. MDCG 2022-18 can be found: HERE
This is an exciting new document, as it outlines the mechanism for manufacturers with expiring MDD/AIMDD CE Marking, to continue placing devices onto the market if their devices are not yet MDR CE Marked. This is to act as a bridging measure until the EU legislation is amended to extend the MDR’s compliance deadline.
A legislative amendment will be introduced early next year to postpone the MDR’s compliance date for legacy devices. More information on the Council’s proposed delay to the MDR deadline can be found: HERE
MDCG 2022-18 was published to provide a uniform application of MDR Article 97 throughout Europe.