EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices regulations, has published a joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission in the sphere of medical devices, has published a Q&A document dedicated to the regulatory requirements for registration in EUDAMED, the new EU-wide database, of actors other...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices regulations, has published a questions-and-answers document dedicated to the European Medical Device Nomenclature (EMDN). It is important to...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices intended to be marketed and used in the EU, has published a joint implementation and preparedness plan for the In Vitro Diagnostic medical devices...
EU MDR/IVDR
The new medical device regulations 745/2017 (MDR) and 746/2017 (IVDR) have introduced an entirely new assessment procedure. This is a crucial process and should be carried out by Notified Bodies. Notified Bodies: Legal Status The new framework introduced by these...
EU MDR/IVDR
Today marks a landmark event for medical device manufacturers around the globe: the date of full implementation of the EU’s MDR. Starting today all new medical device registrations that fall within the scope of the European Medical Device Regulation (MDR) must be...
