EU MDR/IVDR The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices, has published and questions-and-answers document dedicated to repacking and relabeling activities by the Medical Devices Regulation 2017/745...
COVID-19 The European Commission (EC) responsible for medical devices regulatory framework has published an official notice informing about its proposal to roll out the new In Vitro Diagnostic Medical Devices Regulation to ensure uninterrupted availability of vitally important...
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 The Medical Device Coordination Group (MDCG), an advisory body of the European Commission, focused on further improving the regulations in the sphere of medical devices, has published a new visual guide describing the approach to be applied when determining whether...
Europe The SwissMedic, the authority responsible for medical device regulations in Switzerland, has published, in coordination with the EU and MDR, updated regulations: new Medical Devices Ordinance (MedDO) and Clinical Trials for Medical Devices Ordinance (ClinO-MD). These...
