New EU Regulation encourages SMEs and ATMP/device product development
This article was originally published in Clinica
Executive Summary
Assistance is at hand to encourage SMEs to develop advanced therapy medicinal products, including those which are combinations with medical devices or active implantables.
You may also be interested in...
Interim Eudamed Scheme: Early SRN Access To Aid Voluntary Actor Registration
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.
EU Guidance Document To Ensure Devices Are Assessed By Appropriately-Trained Reviewers
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.
Has EU Sorted Expert Panels As Tsunami Of 700 Applications Pour In After Extended Deadline?
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.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: