The commission published the "Proposal for ... amending Regulation (EU) 2017/745" which will defer certain provision of the Regulation by one year. At the same time it will defer the date of repeal of the directives 90/384 EEC and 93/42/EEC by one year.
The Article 1 of the Amendment postpones the implementation of the following aspects form 26. May 2020 to 26. May 2021:
- Publication date für common specifications for Annex XVI products
- Publication date für common specifications for refurbishing
- EUDAMED functionality
- Special market authorization for specific products by C.A.
- Penalties applicable for infringement of the provisions
- Notification in respect to the notified body under the MDD and AIMD
- Devices lawfully placed on the market pursuant to Directives 90/385/EEC and 93/42/EEC may continue to be made available on the market or put into service until 26 May 2025
- Early application of the MDR for placing onto the market
- Early application of C.A.P. under the MDR
- Continue Clinical investigations already started
- Application date of the MDR
- Notified bodies fulfill their obligations under the MDD /AIMD
- EUDAMED implementation
Further the implementation dates for the UDI labelling will as well be prolonged for one more year.