The European Commission (EC), a union-wide authority responsible for medical devices regulations, has announced the launch of the first of six EUDAMED modules – the Actor registration module.
According to the official announcement published by the European Commission, the Actor registration module would become available starting from December 1, 2020. The module is intended to be used by the parties involved in operations with medical devices to submit requests for a single registration number (SRN) – a special number identifying the entity. The aforementioned request should be subject to review by the appropriate national regulating authority. In particular, the following flow should take place:
- An interested entity submits a request for an SRN,
- The responsible national regulating authority conducts an assessment and approves the request,
- The system generates the SRN assigned to the interested entity and provides it to the national regulating authority and the applicant itself.
Under the general rule, all parties involved in manufacturing medical devices, e.g. manufacturers, their authorized representatives, importers, etc., are obliged to obtain a single registration number irrespectively whether they are based in the EU or in non-EU countries.
The interested entity applying for a single registration number shall provide the following information:
- Declaration on information security responsibilities (signed by the person entitled to sign the documents on behalf of the entity), and
- Mandate Summary document (only for non-EU manufacturers having an active mandate with an authorized representative already registered and having its own SRN).
In case if the entity is already registered in EUDAMED, each of its representatives entitled to act on its behalf should submit an access request.
Actor Registration Module FAQs
In order to assist the medical device manufacturers and their authorized representatives in using the Actor registration module, the European Commission has published Actor module FAQs covering the most important aspects related to the new EUDAMED module. In particular, the EC emphasizes the following points:
- Starting from December 2020 only EU countries and some non-EU ones would be available for actor registration. Hence, only the interested parties based in these countries would be able to apply for the registration. However, the interested parties based in non-EU countries would be able to register with EUDAMED providing they have an EU-based authorized representative.
- Due to the BREXIT, the UK national regulating authority would not be registered in EUDAMED and would not have access to it. Consequently, the medical device manufacturers based in the UK would not be able to register in EUDAMED. At the same time, the European Commission states that the situation may change if some new regulations or agreements would take place.
- The Swiss national regulating authority would not be registered as well. According to the information published by the EC, this would be available only after the alignment of existing agreements with the requirements and principles set forth by the Medical Devices Regulation 745/2017 (the MDR) and In Vitro Diagnostic Devices Regulation 746/2017 (the IVDR). The same as UK-based entities, the medical device manufacturers based in Switzerland won’t be able to register with EUDAMED until further changes would take place.
- The same rules should be applied in the case of Turkish national regulating authority and medical device manufacturers based in Turkey.
- The particular Competent Authority (CA) – a national regulating authority responsible for the assessment – should be determined depending on the country the interested entity is based. The European Commission additionally emphasizes that the name of the medical device manufacturer applying for the registration should match its name indicated in the labeling of the medical device. In case if the medical device manufacturer is based in one of the non-EU countries, the CA should be determined depending on the country the authorized representative of the manufacturer is based in. When applying for the registration, the interested party shall indicate the particular competent authority the request should be addressed to.
- The Actor module registration should be based on the role of the entity. Thus, the number of times the entity is registered should be equal to the number of roles it carrels out. Hence, the same entity could have several SRNs – for each type of activity separately. Moreover, the duplicate check system would also utilize the role-based approach.
- When registering with the Actor module of EUDAMED, the interested entity may provide additional information, such as its number in the national business registry or the VAT. Despite the fact that the appropriate fields are optional, the European Commission recommends providing such information in the course of initial registration. These fields would be also checked during the duplicate check procedure. The EC also mentions that by providing such information in advance, the applicant can accelerate the assessment procedure.
- In the case of duplicate applications identified, the information would be transmitted to the Competent Authority for further assessment.
- There is no pre-defined timeline for the application review to be carried out by the Competent Authority. However, under the general rule, such a review should be performed without undue delay.
The FAQs document on the Actor registration module published by the European Commission also provides additional information and clarifications regarding a single registration number and the most important aspects associated thereto.
According to the information published by the EC, an SRN is a special number to be used to identify the particular entity operating with medical devices in all documents and reports. A single registration number also contains a reference to the actor’s role. As it was already mentioned before, each SRN could be associated only with one actor role, even if being assigned to the same legal entity. Upon assignment of an SRN, the applicant would receive the appropriate email. At the same time, the number itself would be provided by the virtue of a special link to the EUDAMED page indicating the number.
It is also important to mention that there are so-called “dummy SRNs” – special SRN intended for testing purposes only. They could be used in a Playground environment where some tests could be performed. These SRNs could not be used in any official documents.
The scope of entities eligible for registration in EUDAMED is quite broad and includes medical device manufacturers, their authorized representatives, and importers. According to the EC, each importer could be linked to an unlimited number of manufacturers, while each manufacturer can also have an unlimited number of importers linked. At the same time, distributors are not required to register in EUDAMED. Moreover, there is no corresponding actor role in the system, so they are not even able to register and obtain a single registration number by default.
Summarizing the information provided here above, the announcement on the Actor registration module launch published by the European Commission covers the most important aspects associated with the first EUDAMED module available. In particular, the EC describes the eligibility criteria, the scope of the information and the document to be submitted, and also the procedure to be followed by the interested entity applying for registration. The EC has also published the FAQs clarifying additional aspects related to the operations of the Actor registration module and SRN numbers themselves.
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