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Medical device regulation: first Eudamed module on line

On 1 December 2020 a further step was taken toward the implementation of the Regulations on medical devices 2017/745 EU and 2017/746 EU (MDR and IVDR).

It is the entering into function of the first module of Eudamed, the single European database introduced by the Regulations, that follows Eudamed2, a much less extended database existing under the current directive, with access reserved for Member States competent authorities.

Eudamed can be accessed directly from the European Commission website; in fact, it was designed to be an interconnected and multifunctional database, made of a web page that can be consulted by the public as well as of the following 6 modules:

  • Actors registration
  • UDI/Devices registration
  • Notified Bodies and Certificates
  • Clinical Investigations and performance studies
  • Vigilance and post-market surveillance
  • Market Surveillance

The first module, that started to be functioning in these days, is called “actors registration module” and for the moment allows the registration of competent authorities and economic operators of the 27 EU nations, with the addition of Liechtenstein, Island and Norway.

For the moment, Swiss authorities have no access to the database, as there is no mutual recognition agreement according to the MDR and IVDR. Turkish authorities are also in a similar situation, as they will not have access to Eudamed because the custom union agreement – in force as of 1 January 1996 – was not extended to the MD and IVD regulations.

Economic operators located in UK will also have no chance to be registered in the database, as for the moment the registration is not provided for even for the relevant competent authority. An information document released by the Commission reads that there will be updates on this regard, with future relation agreements with the United Kingdom and with Northern Ireland, not expected until January 2021.

The access to the first Eudamed module provides for the submission of the required data in the form of an actor registration request that will be subjected to the assessment of the pertinent competent authority. Following a positive outcome of the assessment, the CA will release the SRN (single registration number) generated by Eudamed itself and delivered to the operator via e-mail.

The SRN will represent, even outside the database, a single identification code recognised all over the Union. In the case of extra-EU manufacturers, the submitted request shall be checked by one’s own authorised representative, before being assessed by the national competent authority.

At the moment, it is possible to consult the public section of the first Eudamed module, and it is interesting to note that 58 competent authorities are already present in the database; 31 among them are German. For the moment the Italian CA, the Ministry of Health – is not included.

Next steps in the implementation of the European database will consist in the activation of the second and third module: UDI/Devices registration and Notified Bodies and Certificates, respectively. Both are expected in May 2021. No date has been yet established for the remaining modules.

Written by: Riccardo del Signore

Aggiornato il 05/02/2021

Foto di mohamed Hassan da Pixabay