The European Database on Medical Devices (Eudamed) is one of the key aspects of the new regulations for medical devices.
What is Eudamed?
Eudamed will provide an overview of the lifecycle of medical devices available on the market in the EU. The purpose is to increase transparency, including providing better access to information for the general public and healthcare professionals, as well as improving collaboration between different EU countries.
Eudamed will consist of the following six modules:
- Actor Registration
- Product Registration and Unique Device Identification (UDI)
- Notified Bodies and Certificates
- Clinical Trials and Performance Studies
- Post-Market Surveillance
- Market Surveillance
Registration in Eudamed
The use of Eudamed is not yet mandatory. Until Eudamed becomes mandatory, some requirements in the Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) will be waived. The requirements in forskrift om medisinsk utstyr § 24 will apply as a transitional arrangement.
The Norwegian Medicines Agency encourages Norwegian manufacturers, authorized representatives, importers, and assemblers of systems and procedure packs to register voluntarily in Eudamed before the registration requirement becomes mandatory. Voluntary registration in Eudamed does not replace the registration requirement in the Equipment Register.
The following actors can register in Eudamed:
- Authorized representatives
- Assemblers of systems and procedure packs
How to register in Eudamed
Manufacturers, authorized representatives, and importers of medical devices can register themselves and their equipment. For more information about the registration process in Eudamed.
It is the responsibility of the actors to ensure that the information in Eudamed is always kept up to date.
You can find more information about Eudamed on the EUDAMED information center.
When will Eudamed become mandatory?
Once Eudamed is fully developed, there will be a audit and a transition phase before the database becomes mandatory to use. For more information on the project's progress and how you, as an actor, can prepare already, please refer to the Eudamed Information Center.
Overview of the different roles of economic operators:
Definition in MDR Article 2 and IVDR Article 2
|Manufacturer||A natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark.|
|Authorised representative||Any natural or legal person established within the Union* who has received and accepted a written mandate from a manufacturer, located outside the Union*, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation.|
|Importer||Any natural or legal person established within the Union* that places a device from a third country on the Union* market.|
|Distributor||Any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service.|
|Health institution||An organisation the primary purpose of which is the care or treatment of patients or the promotion of public health.|