The European Parliament completed on 17th December the adoption of a second corrigenda for MDR and IVDR with key impact on some Class I products benefiting from a 4 year grace period (until May 2024) to fully transition to the MDR. However, please note this has no impact on the regulatory obligations for manufacturers to register those medical devices in EUDAMED (including on deadlines).
For further information you can consult the MedTech Europe press release of 18 December.
