Europe
The article provides an overview of the implementing decisions issued by the European Commission for harmonized standards allowed to be applied in the context of general and in vitro diagnostic medical devices under the new regulatory framework. Table of...
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 Medical Device Coordination Group (MDCG), the advisory body of the European Commission, is composed of the representatives of all EU Member states and is entitled to provide clarification regarding the implementation of the EU medical device legislation. They...
Europe
The MHRA and other UK healthcare authorities and associations of manufacturers and suppliers are actively preparing to deal with issues regarding medical devices and medical product supply arising in the case of a no-deal Brexit. Guidance on Medical Products Supply...
