Category: MDR Eudamed

MDR Eudamed News

Selecting an EUDAMED Submissions Partner

Selecting an EUDAMED Submissions Partner Recently while chatting with various manufacturers about their EUDAMED strategies and with various MedTech consultancies on their client’s strategies it has become clear there is…

MDR Eudamed

EUDAMED Timelines (2024) its coming… Q4 2025

EirMed and our partners can help you. The EUDAMED project involves gathering the correct data, validating it against EUDAMED rules, and submitting it to EUDAMED. Next, you will require SoPs…

MDR Eudamed

EUDAMED Q2 2025

Following the European Commission’s EUDAMED working group meeting in June 2023 and the publication of the minutes, we now have a clearer picture of EUDAMED’s future. The minutes of the…

MDR Eudamed

EUDAMED Status?

What is EUDAMED? EUDAMED is the European Commission’s Medical Device and In Vitro Device Database. This is core to the MDR and IVDR regulations. What is the current EUDAMED status? EUDAMED has three live…

MDR Eudamed News

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…

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…