Brexit and Medical Devices UK RESPONSIBLE PERSON = IMPORTER What we already evaluated was strongly confirmed by a representative of the UK MHRA. And ...
Guidance on software classification & other documents
The European Commission indeed works hard to provide further clarification on a number of aspects. Documents are now being issued frequently. It is gr...
Free of charge MDR Authority meeting!
As it seems the Authority of Denmark is concerned with the MDR and provides guidance on the new Regulation. Obtain a detailed guidance for the upcomin...
Brexit – Again!
If you come from the latest Brexit news here is the link back to the article you were reading. UK Responsible Person = Importer with severe addition...
New information on expert panels published
The MDR/IVDR envisages expert panels, who shall assist the European Commission, the Medical Devices Coordination Group, Member States, Notified Bodies...