EUDAMED and the MDR Extension
EUDAMED The MDR extension is being written and spoken about at length, probably because it is a great idea to keep device supplies flowing in Europe and it gives the…
EUDAMED Submissions – UDI DI Reuse for MDD/IVDD and MDR/IVDR Devices
If you use a UDI DI for your directive or legacy devices, MDD and IVDD, EUDAMED allows you to reuse this same UDI DI when this device transitions to MDR…
EUDAMED Timelines, what do they mean for me?
Updated July 2022 The European Commission(EC) has again delayed EUDAMED, this is their delay. Do not forget that we have at least one Competent Authority (Finland) and many importers making…
Finland (FIMEA) makes EUDAMED mandatory. Others to follow?
Finland (FIMEA) makes EUDAMED mandatory. Others to follow? Finland is the first of the competent authorities to make EUDAMED mandatory ahead of the European Commission deadlines. It is mandatory for…
EUDAMED, Importers, and Non-EU Manufacturers – problems!
Both MDR and IVDR now apply, wheater or not it is a reason to celebrate is unclear, but at least we have certainty around the date of application for both…
EUDAMED Device and Certificate modules are live.
Excellent news the EUDAMED Device and Certificate modules are live. It has been a long road but they are now live. Now what? The European Commission(EC) has deployed the EUDAMED…
EUDAMED: Add my device data
EUDAMED: Add my device data The EUDAMED device module will be live in September 2021. The EUDAMED database is complicated and requires a large amount of data from medical device…
Medical Device Regulations and EUDAMED 2021
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, solution.
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…