What is EUDAMED?
Eudamed is the European Databank on Medical Devices. It’s a protected, web-based gateway that serves as a central store for the exchange of important information for national competent authorities to communicate with the European Commission.
What information is stored in EUDAMED?
It depends on the product classification and relevant sections under the old medical device Directive. Eudamed comprises of the following information:
- The registration of medical devices on EU marker, manufacturers, Authorized Representatives
- Declaration of conformity
- A vigilance and traceability system (EU Declaration or statement on ISO certificate)
- Labeling and instructions (Representation in English)
- Rationalization of the classification as per Annex IX
- A copy of ISO 13485 certificate or Evidence of a QMS
- Reports on Clinical Investigations
- Additional documentations may be needed, reliant on the particular characteristics of the device.
EUDAMED 2 is designed on six interrelated modules and a login website (which is open to the public as well in some limited domain). The first module on Actors Registration is going live in December 2020. All six modules are exemplified in the image under;
Actor Registration Request Process
All actors such as importers have to enlist themselves as an actor in EUDAMED and provide the required details. This is related to all in the EU as well as outside EU manufacturers. It also includes actors like system/procedure pack producers, authorized representatives (AR), and importers, etc. The common documents to be sent are also shown in Alysidia’s service package for the actor’s registration.