December 2, 2020
The European Commission has published a FAQ document covering the Eudamed Actor Registration Module on the Eudamed Actors page.
The new FAQ document mainly provides background information needed to understand the context of the Eudamed medical device and IVD database, who should be using it and what they need to prepare. The Actor Registration Module enables the so-called “economic operators” (Manufacturers, Authorized Representatives, Systems and Procedure Pack Producers, but not distributors; see this infographic) to register themselves in the database. This module can be used from December 1, 2020. For now, the use of this module is on a voluntary basis because Eudamed only becomes applicable after all component modules are ready and the database’s launch has been formally announced in the Official Journal of the European Union.
Single Registration Numbers (SRN) in Eudamed
The main reason for an economic operator to register in Eudamed has to do with the Single Registration Number (SRN). This SRN will be the key identifier of an economic operator in Eudamed to link data in other modules (devices, certificates, studies, vigilance, market surveillance). The SRN will be used on Medical Devices Regulation (MDR)-related documents, like the Declaration of Conformity, CE Mark certificates, Summaries of Safety and Clinical Performance and Field Safety Notices. This will allow for unambiguous identification of the manufacturer involved with a device, which should increase agility by Competent Authorities carrying out their market surveillance.
There will be one SRN assigned to each actor role. For example, a manufacturer that also produces procedure packs (be aware this applies for most manufacturers, see MDR Article 22) must enter their data twice for the roles of “manufacturer” and “system and procedure pack producer.” An importer may also act as an Authorized Representative: two roles, two SRNs. But an Authorized Representative mandated by multiple manufacturers has only one role, and therefore only one SRN.
The European Commission has addressed the current turbulence concerning who is part of the EU and who isn’t in the FAQ. Eudamed will ultimately become applicable in the current 27 EU Member States, plus Iceland, Liechtenstein and Norway. The following European countries are explicitly excluded:
- The United Kingdom is no longer part of the EU. Even a trade deal will not automatically open up Eudamed for the UK. At this moment the British Competent Authority, the Medicines and Health products Regulatory Agency (MHRA) is therefore developing its own database for medical devices, which the regulator intends to have up and running by the end of January 2021.
- Switzerland does not have a mutual recognition agreement (MRA) with the EU covering the MDR. As Eudamed is a MDR-related item, the Swiss competent authority Swissmedic cannot register itself in Eudamed, and therefore they cannot manage Eudamed data. This also indicates that non-Swiss economic operators that want to be active in the Swiss market need to register with the Swiss authorities after the date of application of the MDR (May 26, 2021). So far, Swiss authorities have not provided information on this issue. This is the first indication of the consequences for the Swiss market for not having an MRA with the EU.
- For Turkey, more or less the same situation as with Switzerland applies, as the Customs Union Agreement has not been updated for the MDR. Manufacturers in these countries can of course register in Eudamed as non-EU manufacturers, including their Person Responsible for Regulatory Compliance. They need to mandate an Authorized Representative based in the EU.
The Eudamed registration process
In short, the Eudamed registration process starts with the economic operator. These actors must register in Eudamed, after which the relevant Competent Authority can confirm that registration after validating the request. EU-based economic operators must select the Competent Authority in the Member State where they are based. Non-EU manufacturers must select the Competent Authority in the Member State where their Authorized Representative is based.
Manufacturers based outside the EU must verify that their Authorized Representatives register with Eudamed before they themselves do. The non-EU manufacturer must select their Authorized Representative, who will receive a notification of that registration request. Only after the Authorized Representative has confirmed the mandate will the Competent Authority will receive the registration request. If a non-EU manufacturer has mandated more than one Authorized Representative, and these are based in different Member States, the manufacturer can choose one of these Member States according to preference.
At the moment the Actor Registration Module goes live there will also be an “Acceptance” site available. This site will have the same features as Eudamed, except that registrations will not be done for real. Users can get to know Eudamed, try out their own procedures and train their staff. It is important to realize the big difference between “Acceptance” and the real thing, “Production.” The automatic notifications have been turned off. This means that the Competent Authority will not get a notification about a new actor and therefore cannot confirm. The Acceptance site provides the mail addresses that need to be informed to keep the process going. Be aware that the SRN produced by Acceptance is not the real SRN, and no information will be exchanged between the Acceptance and Production sites.
Minimal Viable Product
The FAQ document briefly mentions the term “minimal viable product” (MVP). MVP refers to a solution that just meets the bare-minimum specifications. For Eudamed this more or less means that it is possible for economic operators to register, or for Competent Authorities to perform basic checks on those registrations. In its current form, the MVP module provides little room for detailed analysis supporting market surveillance. But the European Commission has promised that over time more features will be added. Machine-to-machine communication will not be possible in this module. As actor registration does not require large datasets to move, this should not be a problem. Also, the tokens for machine-to-machine communication can only be provided based on the SRN. The SRN can only be generated after a successful registration in Eudamed.
In order to get the module working, first the Competent Authorities must register. They are anticipating a serious work load to facilitate timely processing f registration requests. With the date of application of the MDR in May 2021, it is advisable for all economic operators to be registered by the end of April. The first ‘wave’ of registrants should of course be the Authorized Representatives so their manufacturers can select them when entering their data, and the importers should best step in later because they have to select the relevant manufacturers. Of course economic operators should best clearly communicate their SRN down the line to enable a smooth registration. EU-based manufacturers should aim for February and March for their registration, because around that time the Competent Authorities will have built up sufficient routine, which will compensate for potential delays before May.
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