Category: MDR Eudamed

MDR Eudamed News

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…

MDR Eudamed

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…

MDR Eudamed

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…

MDR Eudamed

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…

MDR Eudamed News

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…

MDR 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…

MDR Eudamed

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…

MDR Eudamed

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…

MDR Eudamed

MDR EUDAMED, how to prepare your spreadsheet templates.

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…

MDR Eudamed

Eudamed early actor registration

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…