OMC Medical
OMC Medical

EUDAMED Medical Devices Registration

EUDAMED

Introduction

Eudamed is the European Database on Medical Devices. It’s a secure, web-based portal developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.

The system is a collection of databases and electronic systems. It will function as a registration system, a collaborative system, a notification system, and a dissemination system (open to the public) and interoperable.

6 Interconnected Electronic Systems and Public Website of Eudamed Medical Devices

European Database on Medical Devices has six interconnected electronic systems and a public website:

  • Actors registration (Economic Operators)
  • UDI/Devices registration
  • Notified Bodies and Certificates
  • Clinical Investigations and performance studies
  • Vigilance and post-market surveillance
  • Market Surveillance

Purpose of EUDAMED Registration

1. To enable the public to be adequately informed about devices placed on the market, the corresponding certificates issued by notified bodies, and the relevant economic operators.

2. To enable unique identification of devices within the internal market and to facilitate their traceability.

3. To enable the public to be adequately informed about clinical investigations and to enable sponsors of clinical investigations to comply with obligations under articles 62 to 80, article 82, and any acts adopted pursuant to Article 81.

4. To enable manufacturers to comply with the information obligations laid down in articles 87 to 90 or in any acts adopted pursuant to Article 91.

5. To enable the competent authorities of the member states and the commission to carry out their tasks relating to this regulation on a well-informed basis and to enhance the cooperation between them.

Information stored in EUDAMED Medical Devices

Depending on the applicable directive, EUDAMED contains data:

  • On registration of manufacturers, authorized representatives, and devices.
  • Declaration of conformity.
  • Justification of the classification according to Annex IX.
  • A copy of ISO certificate/Proof of QMS.
  • Relating to certificates issued, modified, supplemented, suspended, withdrawn, or refused.
  • Obtained in accordance with the Medical Device Vigilance System.
  • Information of clinical investigations.

Actor Eudamed Device Registration

1st December 2020, the European Commission has made available the Actor registration module. It is the first of six  EUDAMED modules.

The actor module is key to accessing and using Eudamed, which allows economic operators to obtain a single registration number (SRN) that provides an EU-wide unique identification.

The actor module also contains a searchable database of registered actors, i.e., economic operators and competent authorities. Actor’s information such as contact information and identification, and for manufacturers, information about the companies’ responsible persons for regulatory compliance can be found on the database.

What are different Actor Roles?

Supervising Entity:

  • Commission (EC)
  • Competent Authority (CA)
  • Designating Authority (DA)
  • Notified Body (NB)

Economic Operators:

  • Manufacturer (MF)
  • Authorised Representative (AR)
  • System and Procedure Pack Producer(PR)
  • Importer (IM)

 *Distributors are not registered in EUDAMED.

To use EUDAMED, you must have an EU Login account – linked to your work email address.

SRN (Single Registration Number): The Single Registration Number (SRN) uniquely identifies every economic operator in EUDAMED. The SRN is issued once the relevant competent authority has validated the Actor registration request.

The economic operator will get a unique SRN for each actor role. If the economic operator has multiple roles, separated registration requests are required to obtain a different and specific SRN for each actor role.

2 ways to Register in the EUDAMED

1 – REQUEST REGISTRATION FOR AN ECONOMIC OPERATOR

  • Register the organization with a specific actor role in EUDAMED. This is considered as an actor.
  • The registered person automatically becomes Local Actor Administrator for that actor once the registration is validated.
  • A Single Registration Number (SRN) is generated by EUDAMED and issued by the competent authority
  • EU manufacturers: If the manufacturer is officially registered (‘established’) in the EU then the manufacturer’s details will be assessed by the competent authority in that country.
  • Non-EU manufacturers: If the manufacturer is not registered in the EU, then during registering in EUDAMED, identify the registered authorized representative on EU territory. The details will first be sent to them for verification (and then to the competent authority). For this, the authorized representatives should register themselves first in EUDAMED.

Information required for registration:

1. Name of organization

2. Role

3. Country

4. VAT, EORI, and national trade number

5. Document for validating request

6. Address details of Economic operator

7. Details of the regulatory person

8. Signed declaration

9. Mandate with an authorized representative (for the non-EU manufacturer)

2 – REQUEST ACCESS AS A USER OF A REGISTERED ECONOMIC OPERATOR

  • If an organization is already registered as an actor in EUDAMED, one can request access as a user of that actor.
  • The search of existing actor can be done with the help of .
  • Once one of the administrators in the actor (an LAA or LUA) has approved your request, your account will be granted the required user profile for that actor

OMC Medical will  help you with all the registration activities in EUDAMED; to know more please contact us at [email protected]