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Explanatory Notes to the UK Medical Devices Bill
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,...
MedTech Europe Warns on MDR Implementation Issues
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...
Notified Bodies and Conformity Assessment in the EU
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...