Category: MDR Eudamed

MDR Eudamed

EUDAMED Timelines, what do they mean for me?

The European Commission (EC) published their EUDAMED timelines but what do they mean for me? EUDAMED Development and Audit Firstly the EUDAMED (version 1) development will end in Q4 2022….

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…

MDR Eudamed

Eudamed delay – a positive move

The MDR Eudamed delay is no longer a rumour, it was confirmed by the European Commission on the 30th of October 2019 on their site for Eudamed and Medical Devices….

MDR Eudamed

Eudamed myths and misinformation

I am often amazed at the people who profess expertise in various fields. Lately the MDR Eudamed experts have been rolling out. Some have not been involved in the many…

MDR Eudamed

EC Publishes UDI Device Data Requirements. Now what?

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 now available. Companies can and…