The European Commission (EC), the European authority responsible for medical device regulations, issued recommendations on conformity assessment and market surveillance procedures within the context of the threat associated with the Coronavirus Disease (COVID-19)...
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...
The Medicines & Healthcare products Regulatory Agency (MHRA), the UK authority responsible for medical device regulation, published guidance dedicated to medical devices without an intended purpose and the way they should be regulated under the Regulation 2017/745...
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,...
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...