EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission composed of representatives of all the EU Member States, issued guidance dedicated to the Unique Device Identification (UDI) system implemented by the Medical Device Regulation...
EU MDR/IVDR
In order to assist all parties involved in operations with medical devices to maintain compliance with applicable requirements under the new framework established by the recent UK Medicines and Medical Devices Bill, special Explanatory Notes have been published. In...
EU MDR/IVDR
Statens legemiddelverk, the Norwegian Medicines Agency, issued an official notice to warn all parties involved in operations with medical devices that have been delayed in the launch of the new European database – EUDAMED. EUDAMED Delay EUDAMED is a database...
EU MDR/IVDR
MedTech Europe, the association of companies that operate on the medical device market, is deeply concerned with the current situation regarding the implementation of Regulation 2017/745 (MDR). The association warns medical device manufacturers, importers,...
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...
