What do we do now that EUDAMED is delayed?
What do we do now that EUDAMED is delayed? – by Ana Quinn
Article 33 of the MDR required the setting up of a European database on medical devices: the widely feared EUDAMED! However, with this now being delayed to May 2022, MDCG 2021-1 has just been published with guidance on harmonised administrative practices and alternative technical solutions for the exchange of information… as an interim advice, to be followed until EUDAMED is properly functional.
If you haven’t had the chance to read it yet, here’s a quick summary of the most important points:
- The summary of safety and clinical performance (SSCP) must still be written and made available to the public
- Manufacturers must mention (on the label or notice) where the SSCP is available
- Clinical investigations for MDD-compliant devices still need to be managed and information from it exchanged, using the existing Eudamed2
Although transitions may appear daunting, it’s better to start laying the groundwork now rather than waiting for EUDAMED to be fully functioning. EUDAMED’s 6 modules will be made available gradually, which presents manufacturers and distributors with the perfect opportunity to get compliant in stages, as these modules become available. As such – you can avoid having to catch up with all 6, once the Commission’s notice is published.
And don’t forget that your procedures will also need to be aligned with any alternatives you may have in place until then.
There are lots of ways to become, and stay, compliant, so IMed will be glad to take you through your options and help you to find the right choice for you and your device.
RA & Clinical Consultant