Commission Issues New Guidance On Registering And Identifying Legacy Devices In Eudamed
The process for registering legacy devices is like that for registering devices in conformity with the MDR. But there are differences and manufacturers also need to understand how deadlines impact them.
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The start date for voluntary registration in the Eudamed 3 database is fast approaching. It is open to all medtech manufacturers with CE marked medical devices from 1 December.
The European Commission is optimistic that work on standards for the new EU medtech regulations will begin as soon as May. After previous setbacks, the medtech sector is pinning it hopes on the EU standards bodies, CEN and Cenelec, accepting the Commission’s latest proposal
The medtech sector has reached the point of exasperation over the European Commission’s handling of virtual audits under the MDR and IVDR. Advantages gained by having a delay in the MDR date of application could be all but lost.