The European Commission (EC) has published a public notification which delays the Eudamed implementation date by 2 years to 26 May 2022.
It was understood that Eudamed will be implemented in separate stages, however, the EC stated that it would only be possible to implement Eudamed once the entire system was developed and validated. It should be noted that this does. Devices should be registered in the same way as they re currently under the directive.
LRQA, MDSAP and new hope for MDR Notified Bodies.
The end of 2019 does not herald any better news from LRQA. After the UK registered NB unceremoniously dropped clients with 90 days’ notice, blaming complications surrounding Brexit, they have now put their MDSAP customers on 30 days’ notice that they will need to find a new assessment body.
Better news is on the horizon though, once NANDO is updated, there should be more choice for notified body to the new MDR/IVDR! Keep checking the link below to be the first to identify who they are!