Medical Devices 
Medical Device Coordination Group Document                                                  MDCG 2020-15       
 
  
 
 
MDCG 2020-15 
  
MDCG Position Paper on the use of the 
EUDAMED actor registration module and 
of the Single Registration Number (SRN) 
in the Member States  
 
August 2020 
 
  
 
This document has been endorsed by the Medical Device Coordinat ion Group (MDCG) 
established by Article 103 of Regulation (EU) 2017/745.  
The MDCG is composed of representatives of all Member States an d a representative of the 
European Commission chairs it. The document is not a European C ommission document and 
it cannot be regarded as reflecting the official position of th e European Commission. Any 
views expressed in this document are not legally binding and on ly the Court of Justice of the 
European Union can give binding interpretations of Union law.   Medical Devices 
Medical Device Coordination Group Document                                                  MDCG 2020-15       
 
 MDCG Position Paper 
on the use of the EUDAMED actor registratio n 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 (her eafter: ‘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 elect ronic 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 producer s of system/procedure packs)  and, where applicable, the 
authorised representative and the importer. As such, the actor registra tion module forms a pre-
requisite 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, Artic le 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 m odule 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 require s the availability and full opera tion 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 th e MDCG agreed that the Commission makes 
available to Member States each EUDAMED module on a gradual basis as soon as it is 
operational. 
In line with the MDCG decision referred to above, the Commissi on 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 obtai n 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, thos e 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 us e of their SRN as required.