Jan 17 - 4:53
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...
Jan 16 - 5:41
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...
Jan 14 - 5:53
The European Commission (EC) has released two new guidance related to the nomenclature of medical devices. CND Nomenclature: Key Points The first document published by the EC describes the “Classificazione Nazionale...
Jan 10 - 5:14
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...
Dec 23 - 7:02
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...
Dec 11 - 4:39
The Spanish Agency of Medicines and Medical Devices (AEMPS) announced the extension of the period provided for medical device manufacturers to implement changes to labeling required due to Brexit. A General Overview of...
