EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for regulations in the sphere of medical devices, has published an explanatory note on codes assigned under the In Vitro Diagnostic Medical Devices Regulation...
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
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...
EU MDR/IVDR
The European Commission (EC), the EU body responsible for medical devices regulatory framework, announces amendments to the designation procedures related to the Notified Bodies (NBs), and also to the rules on the EU-wide derogations. EC New Regulations in Brief Both...
Europe
The European Association of Medical Devices – Notified Bodies (Team NB) issued a position paper describing the application of an exemption rule regarding the endosseous dental implants and dental implant abutments. Dental Implants: Brief Overview According to the...
