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EUDAMED – healthcare progress finds his way also through the european database of medical devices

Registrazione in eudamed

Eudamed: european database of medical devices. It is the unique database of medical devices and it is intended to collect all the data about the medical devices on the European market.

What is EUDAMED?

Eudamed was introduced with the text of Regulation (EU) 2017/745  on medical devices, that became fully applicable on 26 May 2021.

The European database is a cornerstone for the above mentioned Regulation (EU) 2017/745 as well as for Regulation (EU) 2017/746 on in vitro diagnostics.

Eudamed was designed with a dedicated public section, where users and operators can consult plenty of data and useful information on devices, with the specific intent of increasing transparency in the sector and to promote coordination between competent authorities of the various European Member States.

Eudamed is made of 6 modules  that are interconnected one with the other: Actor Registration, UDI Database and Registration of Devices, Certificates and Notified Bodies, Clinical Investigation and Performance Studies, Vigilance and post-market surveillance, Market Surveillance.

The state of the implementation

At the moment, the Eudamed database is not fully operative; so far, only three out six modules are working. Consequently, the requirements provided for by Regulation (EU) 2017/745 regarding information exchange and registration into Eudamed are not yet applicable.

However, economic operators have been offered the possibility to proceed on a voluntary basis, allowing them to progress with their work on regulatory compliance.

The first module became operative in December 2020, thus allowing the registration of manufacturers, authorized representatives, system/procedure pack producers and importers and the related SRN (single registration number). The SRN is the single identification of the operator, that is recognised all over the Union.

With the progress of the activities, in October 2021 the second and third module were made operative, i.e. the UDI and Devices module and the Certificates module.

Based on the latest forecasts of the European Commission, the database full operativity should be achieved in Q3 2023. After that, an audit will be conducted by the Medical Device Coordination Group (MDCG) and the notification provided for by art. 34 of Regulation (UE) 2017/745 will be published in the European Journal.

If so, the obligations related to the use of the database would start as of the last quarter of 2027. Moreover, according to the provisions of art. 123.3 of Regulation (EU) 2017/745, for the obligations on the registration of devices and certificates, further transition periods are expected until Q2 2029.

The New Proposal

With a proposal for a Regulation dated 23 January 2024, the European Commission has informed that they wish a gradual application – however earlier than the transition periods currently provided for – of the registration obligations into Eudamed.

This would occur by carrying out audits aimed at verifying, and in case of positive outcome, at declaring the functionality of the single modules. Thus, the mandatory use of several modules would be anticipated at Q4 2025.

This would allow the whole MD registration system, currently strongly relying on the national databases of the Member States, to start moving more quickly to data centralisation into Eudamed.

Moreover, as stated in the proposal, multiple registrations for manufacturers and double transmissions of data to the authorities could be avoided.

Registration of an economic operator into Eudamed

Eudamed allows the registration of 4 different types of economic operators: manufacturers, authorised representatives, importers and system/procedure pack producers. Access to the first Eudamed module involves the submission of the required data in the form of a request of actor registration, undergoing an assessment by the reference competent authority. In case of positive outcome, the competent authority will release the single registration number.

As for the  extra-EU manufacturers, the request of registration shall be preliminarily validated by the relevant authorised representatives in Europe. After that, the application will be assessed by the reference competent authority of the authorised representative; in case of an Italian authorised representative, for instance, the procedure will be assessed by the Italian Ministry of Health. Once the SRN has been obtained, the operator will have access to the second module for the registration of medical devices.

Registration of a medical device

The registration of a medical device in Eudamed presents some substantial differences compared to the notifications already provided for by the national databases of the European Member States.

The notification procedure is in fact mainly focused on the UDI system, namely on the Basic UDI-DI and UDI-DI of devices.

The Basic UDI-DI identifies medical devices with the same intended use, risk class, and main design and manufacturing characteristics; the Basic-UDI appears in the technical documentation of the device, in particular in the EU Declarations of Conformity and in the EU Certificates of conformity.

On the other hand, the UDI-DI is the specific identifier of the medical device, identifying a model, a variant or a version.

How to register legacy devices into Eudamed

Eudamed also allows the registration of devices still marketed as compliant with the Directive, although Regulation (EU) 2017/745 does not provide for this obligation. These devices are the so called “legacy devices”, and the registration is allowed mainly to ensure their conformity regarding vigilance and surveillance.

However, for legacy devices  there is no obligation of UDI assignation. For this reason, the registration is made via some substitute codes generated by Eudamed itself: the Eudamed-DI and the Eudamed-ID, replacing the Basic UDI-DI and UDI-DI, respectively.

Di Renzo Regulatory Affairs can currently support all types of DM and IVD economic operators to obtain the Single Registration Number or Actor ID as well as for the registration of UDIs and devices into Eudamed.

Written on 15/04/2024 by: Riccardo Del Signore

Foto di Bruno /Germany da Pixabay