04.09.2020
To the attention of Romanian manufacturers/authorised representatives/importers
The use of the EUDAMED “actors” registration module and of the single registration number (SRN) in member states
Article 33 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (hereinafter referred to as the „MDR”) establishes that, following consultation with the Medical Devices Coordination Group (MDCG), the Commission will create, maintain and manage the European database on medical devices (EUDAMED). EUDAMED contains several electronic systems (so-called “modules”), including an electronic system for registering economic operators, called the Actor registration module.
In line with Article 30 (1) of the MDR, the actor registration module should allow the setup of a single registration number („SRN”), gathering and processing the information required in order to identify the manufacturer (as well as the producers of system/procedure packs) and, if appropriate, the authorised representative and importer. Therefore, the actor registration module is a prerequisite for using the other EUDAMED modules and facilitates a secure way of accessing EUDAMED.
The responsibility for assigning a SRN to economic operators belongs to the NAMMDR, as the competent authority. For this purpose, Article 31 paragraph (2) stipulates that, after the verification and validation of the data entered into the EUDAMED by an economic operator, the competent authority of a member state must obtain a SRN from the actor registration module and approve its release to the manufacturer, the authorised representative or the importer who requested this.
On 30 October 2019, the Commission published an information by which it reached the conclusion that the full functionality of the EUDAMED requires the availability and full operation of all six modules and confirmation through an audit. The information foresees the launch of a fully functional EUDAMED for May 2022.
However, in its meeting of 12 March 2020, the MDCG agreed that each EUDAMED module can be made available, gradually, as soon as it is operational. The commission has confirmed the availability to launch the actor registration module starting with 1 December 2020. MDCG members strongly encourage the use of the actor registration module by all relevant actors in their territories, including the use of the SRN by actors, as stipulated in the MDR (e.g. specifying the SRN on certificates).
MDCG members agree that double registration requirements for actors should be avoided as much as possible. Therefore, consideration should be given to actors obtaining an SRN in accordance with actor registration requirements (for manufacturers, authorised representatives, importers, producers of system/procedure packs) to the extent that national legislation allows this. In such cases, actors should comply with MDR obligations and requirements related to both the registration of the relevant actors (via the “actors” registration module) and the use of their SRN, as required.
The NAMMDR announced its intention to participate in the voluntary registration into the EUDAMED, as soon as the actor registration module is functional.
Taken from: https://health.ec.europa.eu/system/files/2020-08/2020-15-position-paper-actor-registration-module_en_0.pdf