MDCG 2021-15

MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States

Disclaimer: This document is an interactive version of the original MDCG document. We will keep it up-to-date.

This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission.

The document is not a European Commission document and it cannot be regarded as reflecting the official position of the European Commission. Any views expressed in this document are not legally binding and only the Court of Justice of the European Union can give binding interpretations of Union law.

MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States

Article 33 of Medical Devices Regulation (EU) 2017/745 of the European Parliament and of
the Council of 5 April 2017 (hereafter: ‘MDR’) sets out that the Commission, after consulting
the MDCG, shall set up, maintain and manage the European database on medical devices
(EUDAMED). EUDAMED shall be composed of multiple electronic systems (so called
‘modules’), including an electronic system on registration of economic operators, also
referred to as the actor registration module.

In accordance with Article 30(1) MDR, the actor registration module shall allow for the
creation of a unique single registration number (‘SRN’) referred to in Article 31(2) and to
collate and process information that is necessary and proportionate to identify the
manufacturer (including producers of system/procedure packs) and, where applicable, the
authorised representative and the importer. As such, the actor registration module forms a prerequisite
for the use of the other EUDAMED modules and facilitates a secure way of
accessing EUDAMED. The responsibility to assign SRNs to economic operators lies with the
Member States. To that end, Article 31(2) stipulates that, after having verified and validated
the data entered by an economic operator, the competent authority of a Member State shall
obtain an SRN from the actor registration module and approve the issuing of it to the
requesting manufacturer, authorised representative or importer.

On 30 October 2019, the Commission published a notice by which it concluded that the full
functionality of EUDAMED requires the availability and full operation of all six modules in
accordance with the technical specifications and confirmed by an audit as referred to in
Article 34. The notice foresees the launch of a fully functional EUDAMED for May 2022.
However, at its meeting of 12 March 2020 the MDCG agreed that the Commission makes
available to Member States each EUDAMED module on a gradual basis as soon as it is

In line with the MDCG decision referred to above, the Commission has confirmed its
readiness to deploy the actor registration module as of 1 December 2020. The members of
the MDCG strongly encourage the use of the actor registration module by all relevant
actors on their territories, including the use of the single registration number
by actors as
stipulated in the MDR (e.g. indicating the SRN on certificates).

The members of the MDCG agree that double registration requirements for actors should
be avoided as much as possible.
Therefore, actors that obtain an SRN should be considered
in compliance with the actor registration requirements (for manufacturers, authorised
representatives, importers, system/procedure pack producers) to the extent that national laws
accommodate for this. In such cases, those actors should follow the obligations and
requirements of the MDR related to both the registration of relevant actors (via the actor
registration module) and the use of their SRN as required.

Revision History

August 2020
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