Clarification about how the various actors, manufacturers, notified bodies and competent authorities should exchange information in the context of the Medical Device Regulation, pending the official launch of the new version of the Eudamed database, is now available. The Medical Device Coordination Group (MDCG) has endorsed a 31-page guidance on harmonized administrative practices and alternative technical solutions (MDCG 2021-1).
Eudamed Timeframe
Eudamed provides the framework to enable the much-demanded transparency in the new regulatory system. It cannot fully apply until all six inter-related modules are ready.
It was originally foreseen that it would be up and running May 2020. But now, it is not due to be officially launched until 26 May 2022, the date of the full application of the IVD Regulation, and exactly one year after the delayed MDR fully applies.
Even after launch, there is a transition period allowing actors in the sector another six months after publication of the notice in the Official Journal of the EU declaring the database fully functional until they need to fully comply. (Requirements set out in MDR Articles 29(4) relating to the registration of devices, and Article 56(5) relating to notified body certificates will fully apply 24 months after the notice.)
In the meantime, and to assist companies in already becoming compliant as far as possible with the new database, parts of Eudamed are being launched on a voluntary basis. Until Eudamed is fully functional and the official notice has been published the use of these parts Eudamed remains voluntary.
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Medtech Insight for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?
