Medical device news

The launch of EUDAMED modules 2 and 3

The European Commission has rolled out the second and third modules of the EUDAMED database. Module 2 relates to the so-called UDI numbers (unique device identification numbers) and device registration. Module 3 relates to notified bodies and certificates. EUDAMED is composed of six modules.

Following the launch of the two new modules, it is now possible for the relevant actors, including notified bodies, to report and register data on medical devices in EUDAMED. It is also possible to search for information in the two modules now. The use of EUDAMED is voluntary until six months after EUDAMED is fully functional. According to the most recent implementation rolling plan, EUDAMED is expected to be fully functional in Q1/Q2 of 2023.

MDCG guidance documents

The Medical Device Coordination Group (MDCG) has prepared two new guidance documents. The first guidance, MDCG 2021-24, concerns the classification of medical devices, while the second guidance, MDCG 2019-6 rev. 3, is an update of an existing guidance on requirements relating to notified bodies. The latter document contains relevant questions and answers regarding this area.

All the MDCG's guidance documents can be found here.

The status of the MDCG's ongoing guidance development can be found here.

Plesner continuously monitors medical device developments.

You are welcome to contact us if you need advice in this area.