EU Regulatory Roundup, November 2019: Big Changes For Medtech Regs Implementation
With six months left to the full implementation of the EU’s Medical Devices Regulation, there are a couple of big shifts taking place in the way it is being applied. Following news of the Eudamed database two-year delay, confirmation looks imminent that many more products will avoid having to comply with the MDR by next May. But will this plan sufficiently alleviate implementation pressures?
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.