In Europe the regulatory community follows closely the latest MDR developments. The rumors, that certain class I products may receive a significant ex...
NO INDEPENDENT UK RESPONSIBLE PERSON (RP) POSSIBLE!!!
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...
Another update on UK guidance!
Published September 3. We will review this new update and check whether it effects our Responsible Person (RP) contract and update accordingly if need...
It`s about time…
It is about time to start YOUR MDR/IVDR project. Even though the whole world is lamenting about the new Medical Device Regulation (MDR) and In-vitro D...