EUDAMED is a product- and manufacturer-related database in which manufacturers are required to store data in accordance with the new European regulations for the development, manufacture, marketing and product monitoring of medical devices within the EU in the form of the MDR (PDF) and IVDR (PDF).
Originally, this data was to have been collected by the planned effective date of the MDR (26 May 2020), with a 18-month transition period provided for by the European legislator. However, the Commission delayed the introduction of EUDAMED by two years last October because it feared that the system would not be ready in time for the original target date of May 2020. However, this postponement has no impact on the effective date of the MDR itself, which is (currently) 26 May 2021.
The database is intended to monitor the safety and effectiveness of medical devices as part of the now delayed Medical Devices Regulation. In March, the MDCG (Medical Device Coordination Group) (PDF) and the Commission agreed to make the six modules (that comprise EUDAMED) available on an ongoing basis as soon as they become available.
At that time, the Commission predicted that the Actor Registration Module (ACT) would be ready by March 2021. Part of this plan has recently been changed: the Actor Registration Module is now scheduled to be available as early as the beginning of December 2020.
The MDCG is now preparing the industry for the introduction of the module, which will enable product manufacturers, authorised representatives and importers to obtain the SRN (single registration number) they ultimately need for certificates.
As there are still almost 18 months between the introduction of the module and the full launch of EUDAMED, organisations now have more time to obtain the SRN they need to use other functions of the database. This development would represent a significant improvement in the situation, especially as there were recently fears that Member States would have to validate all registration applications within two months.
The introduction of this module is intended to be the first in a series of steps towards the full implementation of EUDAMED. Two further modules (product registration, UDI – Unique Device Identification, and certificate, CRF – Certificate) are to be put into operation by May 2021, as the Commission is working towards its goal of having a system ready for testing in time to bring the database online in 2022. In anticipation of the launch, the Commission published a fact sheet last month with details on EUDAMED information that will be publicly available.
A guidance document for users of the EUDAMED database can be found here (PDF).
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