MDR Clinical Investigation Reports: EU Guidance Sets Out Timelines
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.
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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.