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’s proposal to extend transition timelines for legacy devices in the context of the Medical Device Regulation is already on the move. There are still questions, however, about whether a fast-track adoption is in the best interests of the medtech sector.
A review of expert panel opinions related to high-risk medical devices shows no challenges yet by notified bodies to their findings.