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...
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...
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...
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...
The European Commission (EC), the European authority in the sphere of medical devices, has proposed a new framework for the use of Artificial Intelligence technology in medical devices. The document is intended to introduce harmonized rules for AI-based medical...
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission, the regulating authority in the sphere of medical devices, has published questions & answers on clinical investigation. Please note that the document does not represent the...