New Guidance On Registration Rules For Importers Into The EU
EU rapidly revises new guidance document on registration requirements under the new MDR and IVDR to address question of when importers need to register in Eudamed medical device database.
You may also be interested in...
Work is progressing towards publications of an updated list of standards to support implementation of the EU’s new medtech regulations.
The EU needs to go further when it comes to allowing the use of electronic IFU for all professional use medical devices and fall more closely into line with other global markets.
Will the EU agree that Article 97 is the way to go to avoid notified body bottlenecks in the context of the Medical Device Regulation? This matter is now being reviewed at the highest levels.