Scope of EU device directives to be widened to include cosmetic devices & genetic tests
This article was originally published in Clinica
The scope of the medical device directives looks set to widen significantly to include invasive “well-being” or “aesthetic” devices that do not have a specific medical purpose, Clinica has learnt.
You may also be interested in...
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.