As per the new EU MDR 2017/745 and IVDR 2017/746; the European Commission (EC) has elucidated its first module on the actor’s registration for the new EUDAMED system. As previously recognized, EUDAMED stands for the European Databank on Medical Devices. It’s a protected, web-based software platform that functions as a central point for information sharing between the European Commission (EC) and its several national competent authorities (CAs). It is the exclusive online observing system that will be employed to control the performance of medical devices for their safety. The earlier version of EUDAMED 1 under the old directives was implemented in May 2011 and was embedded with the related intent of assisting market surveillance and transparency in the European countries for medical devices. Therefore the new EUDAMED 2 is expected to improve transparency and management of medical devices available on the EU marketplace better than the EUDAMED 1.
EUDAMED 2 is designed on six interrelated modules and a login website (which is open to the public as well in some limited domain). The first module on Actors Registration is going live in December 2020. All six modules are exemplified in the image under;
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Why is the Actor’s Registration Module so important?
All economic operators of medical devices in the European market should acknowledge the significance of the actor registration module. The reason that makes it very important for all is the fact that the Actor Registration Module is compulsory for subsequently consuming EUDAMED and using the rest of the five modules. Hence it is advised to economic operators in the EU market to quickly begin the course of listing their companies to the actor registration module in all the subject European regions. Of course with the EUAMED 2; the application of the single registration number (SRN) by actors will become significant as referenced in the MDR i.e. Medical Device Regulation.
One of the main benefits of getting registered with the Actor registration module is the point where it allows economic operators to send, through this process, the information necessary to obtain a single registration number (SRN). The actor registration module will be live for registrations in December 2020, and with that SRN can be acquired by actors for different roles.
Actors Classification in EUDAMED
The term actor is concerned with a legal person or natural entity with a specific role that has to be recorded through EUDAMED. Actors relevant to EUDAMED are shown below;
What is an SRN?
The Single Registration Number (SRN) precisely identifies every single actor or played in EUDAMED. The SRN is shared as soon as the relevant competent authority (CA) has authenticated the Actor registration request. The SRN provides an EU-wide unique identification for all economic operators. This unique identification may also be equally applicable outside the EU as well.
Following the assessment and approval of the request by the associated state competent authority (CA), EUDAMED issues the SRN of the economic operator to the national competent authority (CA) and also emails that to the applying individual for that economic operator.
Actors’ Registration Validation
The validation for actor registration is done in steps which are listed as;
- The economic operator sends an application in EUDAMED for an actor registration request and shares required documents by uploading it on EUDAMED.
- If there is a non-EU medical devices manufacturer, then only the authorized representative confirms the registration request by verifying it. And then only the request can be forwarded to the relevant competent authority (CA) for appraisal and assessment.
- The concerned competent authority (CA) authorizes the SRN to be provided by EUDAMED once they endorse the registration request.
- EUDAMED notifies the SRN and registration acceptance through email to the related individual of the subject economic operator.
Local Actor Administrator (LAA)
LAA privilege is automatically assigned to the individual who sends the details of an actor in EUDAMED; once the registration actor request has been endorsed. As LAA, the user can administer all the particulars for corporate actors in EUDAMED (for example the company name, postal address, Value added tax information, etc.). The LAA can also manage user access requests. It is advised for every single actor to have two LAAs at least. One of them should be a person reliable from the internal team of the company.
When competent authority (CA) has authorized an economic operator and the SRN is delivered, amendments to registration particulars can only be updated by the LAA. Apart from variations and notification email addresses, all changes make a new version of that economic operator. Previous versions will be there for availability at any time to avert any ill use.
Registering as a non-EU manufacturer
For all manufacturers outside the EU (European Union) or are not registered with their offices in the EU, the registration process varies from those present in the EU. Outside EU companies must also choose the authorized representative whom they have cooperated with and if any organization has numerous representatives then there is a prerequisite to select the primary representative (with already having the SRN issued in the EU).
The authorized representative (AR) for a manufacturing company outside the EU; has to confirm the manufacturer’s registration details before the request is submitted to the competent authority (CA) for validation. Therefore any entity working as AR who will be helping the companies outside the EU, they have to be enlisted with EUDAMED first.
So all manufacturers outside the EU need to verify the SRN for that authorized representative before selecting them as their patron in EUDAMED.
Who are eligible Authorized Representatives and how companies outside the EU can identify them?
The authorized representatives who are qualified to authenticate a company outside the EU need to have a ‘Verifier Profile’ in EUDAMED. The authorized representatives who can confirm as authorized representatives are referred to as “AR Verifiers”. Hence the non-EU manufacturers have to collaborate with representatives owning such EUDAMED profile. The Verifier Profile in the EUDAMED system allows the Authorized representative’s Local Actor Administrator and Local User Administrator to verify a non-EU manufacturer.
Actor Registration Request Process
All actors such as importers have to enlist themselves as an actor in EUDAMED and provide the required details. This is related to all in the EU as well as outside EU manufacturers. It also includes actors like system/procedure pack producers, authorized representatives (AR), and importers, etc. The common documents to be sent are also shown in Alysidia’s service package for the actor’s registration.
Important Document to Offer with the Actor Registration Request
Declaration on information security responsibilities: All economic operators must upload a signed Declaration on information security responsibilities.
Mandate Summary Document: This need is exclusively for manufacturers outside the EU, while they are also mandated to register in EUDAMED, they must have an enlisted authorized representative and upload the registration of a Mandate Summary document as well.
EUDAMED registered users: For an actor’s users; who are previously registered as an actor in EUDAMED; all folks who are anticipated to do their jobs on behalf of the approved actor need to send an access request.
User Access Request
Once an actor is registered in EUDAMED with its Local Actor Administrator (LAA) and has attained an SRN, supplementary users of a subject actor can request access to EUDAMED. Once the SRN is attained, the first user i.e. Local Actor Administrator (LAA) of the actor can utilize the EUDAMED and start managing its Actor users’ access requests. Finally, the LAA has its own Local User Administrator (LUA), whose primary job is to supervise all access requests from other users of that actor.
Empowering Companies & their Registration with EUDAMED
Alysidia can empower companies to register with the Actor’s registration module. Please contact us through our service description page for this service and we will assist smoothly in the preparation to register under the EUDAMED 1st module.