PinnedEUDAMED 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.Oct 6, 2021Oct 6, 2021
PinnedEUDAMED: Adding my device dataThe EUDAMED device module will be live in September 2021. The EUDAMED database is complicated and requires a large amount of data from…Aug 21, 2021Aug 21, 2021
PinnedMedical Device Regulations and EUDAMED 2021The European Commission adopted Medical Device Regulations in 2017. There are two regulations, Medical Devices Regulation (MDR 2017/745)…Jan 18, 2021Jan 18, 2021
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…Jun 23, 2020Jun 23, 2020
Eudamed myths and misinformationI am often amazed at the people who profess expertise in various fields. Lately the MDR Eudamed experts have been rolling out. Some have…Jun 29, 2019Jun 29, 2019
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 available…May 29, 2019May 29, 2019
Eudamed “Medical device regulation” Why Worry?The regulations are in place, the EC is preparing MDR Eudamed, and the go-live deadline is March 2020. The EC reports that everything is…Dec 21, 2018Dec 21, 2018
What is MDR (Medical Device Regulation)?Eudamed is the European Databank on Medical Devices. Eudamed has been in existence for many years but only accessible by the European…Sep 22, 2018Sep 22, 2018