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...
Jan 8 - 6:21
The Medical Device Coordination Group (MDCG), an advisory body composed of the representatives of EU member states, issued guidance dedicated to cybersecurity issues. Scope of the Guidance According to the medical...
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 18 - 5:44
Switzerland is going to amend its current medical device regulations in response to the changes implemented by Regulation 2017/745 (MDR). Mutual Recognition Agreement A mutual recognition agreement in the area of...
Dec 16 - 7:59
The Medical Device Coordination Group (MDCG), the advisory body that consults the European Commission on the implementation of laws surrounding medical device circulation, issued guidance related to a new codification...
Dec 13 - 7:36
The Medical Device Coordination Group (MDCG), the advisory body assisting the European Commission on issues related to the implementation of legislation regulating the circulation of medical devices, has published...
