EUDAMED
Published:
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Updated:
Changes
- : Added information statating that EUDAMED will be mandatory from May 28, 2026.
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 first four modules of EUDAMED will become mandatory to use from May 28, 2026. Until then, the use of EUDAMED is voluntary, and certain requirements in MDR and IVDR are waived. The requirements in the forskrift om medisinsk utstyr § 24(Ekstern lenke)(Ekstern lenke) apply as a transitional arrangement.
DMP encourages Norwegian manufacturers, authorized representatives, importers, and assemblers of systems and procedure packs to register now. Voluntary registration in EUDAMED does not replace the registration obligation in the Equipment Register, which remains valid until May 28, 2026.
The following entities must register in EUDAMED:
- Manufacturers
- Authorized representatives
- Importers
- Assemblers of systems and procedure packs
How to register in Eudamed
Manufacturers, authorized representatives, and importers of medical devices can register themselves and their devices. 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?
EUDAMED will be launched gradually, and the three modules for actor registration, equipment, and certificates are already available on a voluntary basis. On May 28, 2026, these modules, along with the market surveillance module, will become mandatory to use.
The vigilance module will be the next module to become mandatory after this, but no date has yet been set for its mandatory use.
The introduction of EUDAMED requires extensive preparations. For more information about the progress of the project and how you, as an actor, can prepare, please refer to the EUDAMED Information Center.
NoMA will provide updates as further information becomes available.
Overview of the different roles of economic operators:
| Economic operator |
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. |
