All Upgraded Class I Devices Could Benefit From 4-Year Extension As Corrigendum Details Emerge
The text of the EU’s proposed second corrigendum to the Medical Device Regulation is available. It promises to lift the pressure on notified bodies and manufacturers alike.
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The new Eudamed database may be delayed for two years, but the European Commission wants to allow early access to Single Registration Numbers before Eudamed goes live in 2022 to aid voluntary registration in the interim.
How do notified bodies ensure that their personnel, and the teams they allocate for conformity assessment of medical devices, have the precise knowledge and expertise needed? A new EU document gives guidance on this.
Only just over a month ago there were fears that the implementation of the EU Medical Device Regulation was going to be hampered by a lack of expert panel applicants. Now it seems there is no shortage. The news raises lots of questions about when and how the structure will now work.