The Commission concluded that it will only be possible to make EUDAMED operational once the entire system and its different modules have achieved full functionality…
Posts published in “Medical Device Regulation MDR”
Ongoing Guidance development within MDCG Subgroups
So it seems EUDAMED will be delayed by 2 years. Let’s see if an official announcement is made soon…
Questions & Answers on Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746)
Flyer – Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05)
MDCG 2019-12 – Designating authority’s final assessment form: Key Information (EN)
Finally got my copy of this interesting book on grey literature, which has great impact on medical device regulatory compliance. One of the definitions of…
Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR
Another series, initiated in a Linkedin post. The PMS process is nothing more than a research project focused on answering specific questions related to the…