EU MDR/IVDR The new article addresses certain specific aspects related to post-market surveillance in the context of medical devices certified under the Directives. Table of Contents The Medical Device Coordination Group (MDCG), an advisory body of the...
EU MDR/IVDR The article provides an overview of the new guidance document issued by the MDCG about surveillance in the context of MDR transitional provisions. Table of Contents The Medical Device Coordination Group (MDCG), an advisory body of the European...
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...
EU MDR/IVDR The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices, has published a guidance document dedicated to the applicable classification rules. The document is intended to provide medical device...
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 Medical Device Coordination Group (MDCG), an advisory body of the European Commission in the sphere of medical devices, has published a guidance document dedicated to the current classification rules. The document is intended to assist medical device manufacturers...
