The Medical Device Coordination Group (MDCG) has published a document MDCG 2021-1, outlining harmonised administrative practices and alternative technical solutions that may be used before EUDAMED is fully functional.

📢 Key Takeaways

(1)    “On 30 October 2019, the Commission published a notice by which it concluded that the full functionality of EUDAMED requires the availability and full operation of all six modules, both individually and jointly.”

(2)    “…addresses the possibility that EUDAMED is not fully functional on the date of application of the MDR (26 May 2021).”

(3)    “The proposed practices and solutions aim to enable Member States and other relevant parties to meet their obligations under the MDR effectively while minimising any potential additional burden on the parties concerned.”

(4)    “This guidance addresses in particular cases where the exchange of information would be difficult, or even not possible, to achieve based on the corresponding provisions of Directives 90/385/EEC and 93/42/EEC.”

📚 Documents:

·         MDCG 2021-1  :  https://bit.ly/2PGftsA