The European Commission adopted Medical Device Regulations in 2017. There are two regulations, Medical Devices Regulation (MDR 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746). EUDAMED is…
Authorised Representatives, Distributors, and importers appear to be the “Soup De Jour” for a lot of excellent industry blogs and articles. Lots of words are being written about their legal…
MDR EUDAMED, how to prepare your spreadsheet templates. The European Commission (EC) delayed the release of MDR EUDAMED until May 26th 2022, MDR now applies and IVDR will apply from…
EUDAMED delay: A small change of plan, voluntary registrations in December 2020 In our earlier articles, we pointed out that the Medical Device move from DG GROW to DG SANTE…
The MDR Eudamed delay is no longer a rumour, it was confirmed by the European Commission on the 30th of October 2019 on their site for Eudamed and Medical Devices….
I am often amazed at the people who profess expertise in various fields. Lately the MDR Eudamed experts have been rolling out. Some have not been involved in the many…
EUDAMED — EC Publishes UDI Device Data Requirements. Now what? The European Commission (EC) has finally published the UDI Device data requirements. The long-awaited data structures are now available. Companies can and…