EUDAMED The MDR extension is being written and spoken about at length, probably because it is a great idea to keep device…
If you use a UDI DI for your directive or legacy devices, MDD and IVDD, EUDAMED allows you to reuse this same…
Updated July 2022 The European Commission(EC) has again delayed EUDAMED, this is their delay. Do not forget that we have at least…
Finland (FIMEA) makes EUDAMED mandatory. Others to follow? Finland is the first of the competent authorities to make EUDAMED mandatory ahead of…
Both MDR and IVDR now apply, wheater or not it is a reason to celebrate is unclear, but at least we have…
Excellent news the EUDAMED Device and Certificate modules are live. It has been a long road but they are now live. Now…
EUDAMED: Add my device data The EUDAMED device module will be live in September 2021. The EUDAMED database is complicated and requires…
The European Commission adopted Medical Device Regulations in 2017. There are two regulations, Medical Devices Regulation (MDR 2017/745) and the In Vitro…
Authorised Representatives, Distributors, and importers appear to be the “Soup De Jour” for a lot of excellent industry blogs and articles. Lots…
MDR EUDAMED, how to prepare your spreadsheet templates. The European Commission (EC) delayed the release of MDR EUDAMED until May 26th 2022,…
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