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17.11.2020

What economic operators will have to do with the EUDAMED database as of 1 December 2020.

In order to obtain a registration number for authorities containing all relevant information on companies/manufacturers and co, economic operators such as medical device manufacturers will have to register in the first of 6 EUDAMED database modules as of 1 December 2020.

EUDAMED_Registrierung
EUDAMED_Registrierung
EUDAMED_Registrierung
EUDAMED_Registrierung

On December 1st, the European Commission will make available the Actor registration module to Member States and economic operators. It is the first of six EUDAMED database modules to be made available. The next two data base modules are planned to be accessible in May 2021, and the commission works towards bringing the complete database with all six modules online in 2022.

 

Overview

EUDAMED is the database developed by the European Commission to implement certain requirements of Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on IVDs. It will be multipurpose and function as a registration system, a notification system and a dissemination system (in parts open to the public) at the same time, improving transparency and coordination of information on medical devices available on the EU market.

In order not to be on hold for even longer time the European Commission pushed the EUDAMED going online as soon as possible with at least one module. So get ready, the time has come for economic operators to register from December the 1st.

Generally, the EUDAMED database consists of 6 interconnected modules:

  1. Actors registration (Dec 1st 2020)
  2. UDI/Devices registration (May 2021)
  3. Notified Bodies and Certificates (May 2021)
  4. Clinical Investigations and performance studies
  5. Vigilance and post-market surveillance
  6. Market Surveillance

The different modules will be made available on a rolling basis and as soon as they are functional. Plans of the Commission and the Medical Device Coordination Group (MDCG) are that on December 1st 2020, the first module, Actors registration, will go live. The second module on UDI/device registration and the third module on Certificates and Notified Bodies are planned to be available by May 2021.

Access to the EUDAMED database will be via: https://webgate.ec.europa.eu/eudamed as of 1.12.2020.
The EUDAMED webpage will be accessible here: https://ec.europa.eu/tools/eudamed as of 1.12.2020
 

So what is Module 1 – Actors Registration?

The actor registration module is an electronic system on registration of the economic operators, i.e. all companies that act as “Manufacturer”, “Authorised Representative” and “Importer” as well as “System & Procedure Pack Producers”.
It allows the creation of the unique, so-called single registration number (SRN) (as MDR Article 31(2) requires) and enables economic operators to submit the necessary information such as Name, Address, Country, Contact Data. With their SRN, economic actors can be clearly identified throughout the EU. The actor registration module will process the information necessary to clearly identify the manufacturer (incl. producers of systems or procedure packs), authorised representatives and importers. More details can be found in the MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States:

 

An actor is a natural or legal person (organisation) with a specific role that has to be registered in EUDAMED.

For EU based economic operators the SRN request is being assessed and approved by the national competent authority in the first place and after that the SRN is issued and provided to the requesting economic operator by an EUDAMED e-mail.

For non-EU manufacturers the authorised representative has to verify the registration request made by the manufacturer upon submitting an actor registration request, before it is passed on to the national competent authority. After approving the registration request, the responsible national competent authority issues the SRN and the non-EU manufacturer is notified via an EUDAMED email as well.

The EU has provided graphic overviews of the different actor roles in EUDAMED (Economic Operators, Supervising entities) and the equivalent validation process as well as on the registration request process.


What else do you need?

The Local actor administrator (LAA)

The local actor administrator is the central point of contact between the competent authorities and the economic operators. Each economic operator has to stipulate a LAA, delegates user access management and user management of his EUDAMED entry to the LAA and equips him with certain rights regarding granting / managing / removing access to his EUDAMED entries.

But where do you stipulate the LAA? Well …

Documents necessary for the actor registration request

  • Declaration on information security responsibilities
    This template is available in all EU languages and must be signed and uploaded by all actors. It includes identification of the “Economic Operator Actor” and stipulation of the LAA The document can be found here: Declaration on information security responsibilities
  • Mandate summary document for Non-EU manufacturers
    Non-EU manufacturers that wish to register in EUDAMED must have an authorised representative. Together with their registration, they have to submit a Mandate Summary document, which can be found here: Mandate Summary document

If you as an actor are already registered in EUDAMED, all persons intending to act on your behalf need to enter an access request.. Those “Local user administrators” (LUA) have to be “unlocked” by the LAA upon request.

The following infographic on user access requests gives an overview on the process: Users access requests

This all sounds quite complicated? Well, aspecial guide for using the actor registration module has been created by the EU and is also already available: Guide to using EUDAMED

Further details on the Actors Registration Module and process can be found on the dedicated webpage of the European Commission:
https://ec.europa.eu/health/md_eudamed/actors_registration_en
 

Further useful information:
Further details on the Actors Registration Module and process can be found on the dedicated webpage of the European Commission:
https://ec.europa.eu/health/md_eudamed/actors_registration_en


Transparency Fact Sheet

In the run-up to the release, the Commission has published a fact sheet which “lists information that will be available to the public in accordance with transparency obligations in MDR considering that some requirements will be applicable only once the European database on medical devices (EUDAMED) is fully functional.” This fact sheet provides important information on which data will be openly accessible and makes it easier for each operator to be aware of this. Find this fact sheet here: Fact sheet on MDR requirements for Transparency and Public Information   


With the 1. December 2020 coming closer and thus the release of the first module, manufacturers and other parties are well advised to inform themselves and to obtain their SRN by using the actor registration module.

 

Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.

Every product is unique – the mandatory tasks and measures for entering the market need to be specified individually. seleon advises you on your individual questions without any obligation.

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