The European Commission (EC) has explained its first module on the actor’s registration for the new EUDAMED system under the new EU MDR 2017/745 and IVDR 2017/746. As already known, EUDAMED means European Data bank on Medical Devices. It’s a safe, web-based application that serves as a source for communicating information between the European Commission (EC) and the various national competent authorities (CAs). It is the online monitoring system which will be utilized to regulate the safety and performance of devices under two new regulations which are Medical Devices Regulation (MDR 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746). The first version of EUDAMED under the old directives was enforced in May 2011 and was made with the similar objective of supporting market surveillance and transparency in perspective of medical devices put on the European market. Therefore the new EUDAMED is anticipated to enhance transparency and harmonization of medical devices available on the EU market better than the first one.
EUDAMED is based on six interconnected modules and a website (which is accessible by public.). The first module is going to be enforced on December 2020. The six modules are illustrated in the image below;
Actor’s Registration Module
Why is Actor’s Registration Module so important?
The actor registration module is incredibly important for all economic operators of medical devices in the European market. The incredible reason is that Actor Registration Module is a mandatory for using EUDAMED and utilizing all other modules. Therefore it is encouraged to all to immediately start the process of registering to the actor registration module in all the target territories, also alongside with the application of the single registration number (SRN) by actors as referenced in the MDR i.e. Medical Device Regulation.
One of the biggest advantages registering to the Actor registration module is the fact that it empowers economic operators to submit, through an actor registration request, the information essential to acquire a single registration number (SRN). The actor registration module will open for registrations in December 2020.
Types of Actors in EUDAMED
The term is actor is related to a natural or legal person with a specific role that has to be registered in EUDAMED. Actors involved in EUDAMED are illustrated below;
What is an SRN?
The Single Registration Number (SRN) exclusively recognizes every economic operator in EUDAMED. The SRN is given out as soon as the pertinent competent authority has validated the Actor registration request. The SRN confirms an EU-wide unique identification for economic operators (while some claim that is also unique outside of EUDAMED).
Subsequent to the evaluation and approval of the request by the related national competent authority, EUDAMED produces the SRN of the economic operator to the national competent authority and transmits it to the applying economic operator.
Validation Process for Actor Registration
The validation process for actor registration is as under;
- The economic operator applies in EUDAMED for an actor registration request and submits relevant documents.
- For non-EU medical devices’ manufacturers, its authorised representative authorizes the registration request before sending it to the national competent authority (CA) for evaluation and assessment.
- The national competent authority (CA) allows the SRN to be generated by EUDAMED once they approve the registration request.
- EUDAMED informs the SRN and registration through email to the relevant economic operator.
Local Actor Administrator (LAA)
The individual who essentially provides the particulars of an actor in EUDAMED automatically becomes the LAA for that actor once the registration request has been accepted. As LAA, one can manage all the details for company’s actor in EUDAMED (for instance the name, address, tax information, etc.) along with user access requests. It is always recommended for every single actor to have as a minimum of two LAAs. One of them should be trustworthy internal part of the organization.
When competent authority (CA) has validated an economic operator and the SRN is issued, modifications to registration details can only be incorporated by the Local Actor Administrator. Apart from changes and notification email addresses, all modifications make a new edition of the actor. Earlier versions will be there for accessibility at any time to prevent any misuse.
Registering as a non-EU manufacturer
For all medical device manufacturers who are located outside the EU (European Union) or is not registered in the EU, the registration process differs from the one present in EU. Outside EU manufacturers must also select the authorised representative whom they have collaborated and if any company has multiple representatives then there is a requirement to identify the main one with the SRN issued in the EU. The authorized representative for a manufacturing concern outside EU; has to verify manufacturer’s registration details before the request is deferred to to the competent authority (CA) for validation. Therefore any representative who will be assisting the companies outside EU, they have to be registered with EUDAMED first.
The authorized representatives who are eligible to verify a company outside EU must have a ‘Verifier Profile’ in EUDAMED. The authorized representatives who can verify as authorized representatives are denoted by “AR Verifiers”. So the non-EU manufacturers have to get themselves verified by representatives holding this profile. By default, the Verifier Profile representative’s Local Actor Administrator and Local User Administrator also have the rights to verify non-EU manufacturer.
Request Process for Actor Registration
All economic operators’ importers have to register as an actor in EUDAMED and offer the needed information. This is applicable for all in the EU or outside EU manufacturers, authorised representatives (AR), system/procedure pack producers and importers etc. The general documents list to be submitted is also provided in our service package for actor’s registration.
Important Document to Offer with the Actor Registration Request
Declaration on information security responsibilities: All actors must provide a signed Declaration on information security responsibilities which needs to be uploaded in EUDAMED.
Mandate Summary Document: This requirement is for outside EU manufacturers, while they need to register in EUDAMED, they must have an active authorised representative and submit along with the registration of a Mandate Summary document.
EUDAMED registered users: For an economic operator already registered as actor in EUDAMED, all professionals who anticipate doing their jobs on behalf of the subject actor need to send an access request.
User Access Request
Once an actor is listed in EUDAMED with its first Local Actor Administrator (LAA) and has acquired an SRN, more users of this actor can request access to EUDAMED. Once the SRN is acquired, the first user i.e. Local Actor Administrator (LAA) of the actor can use the EUDAMED and begin administering its Actor users’ access requests till the actor has its own Local User Administrator below LAA, whose main function is to manage access requests from other users of that actor.
Helping Companies getting registered with 1st Module of EUDAMED
TS Q & E can help you register with Actor’s registration module. Please contact us through our service description and we will help you prepare to register under EUDAMED 1st module.