Eudamed: Four Modules Due To Come Online By Mid-2021
The medtech sector is getting impatient with the European Commission’s frequent changes in the launch date for the new Eudamed medical device database, a foundation stone for the new regulations. The commission has just announced an ambitious new timetable.
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While the date of readiness of the clinical investigation module of the Eudamed database is still unknown, the EU is gearing up to ensure sponsors know their obligations as soon as it comes on board.
Voluntary “actor” registration under version 3 of the new Eudamed database, a vital cornerstone of the Medical Device Regulation, will not take place this May as had been planned.
The UK responsible person is the UK equivalent of the Authorized Representative in the EU. MedTech Europe’s Jesús Rueda gives an update on the early experiences of medtech manufacturers seeking to comply with the UK’s new standalone regulations.