What is Eudamed?
Eudamed is the European Databank on Medical Devices. It’s a secure, web-based portal that acts as a central hive for the exchange of information between national competent authorities and the European Commission. The portal cannot be accessed by the public. Eudamed came into force in May 2011 and was created with the purpose of strengthening market surveillance and transparency with regards to medical devices placed on the European market.
How does Eudamed achieve this?
Eudamed is providing national competent authorities with fast, simple access to relevant regulatory information. It also assists with the implementation of a uniform approach to the Medical Device Directives.
What is stored in Eudamed?
Depending on the the product classification and applicable provisions under the Directive, Eudamed will contain some or all of the following data:
- The registration of manufacturers, their Authorized Representative and the devices in question;
- Declaration of conformity
- A vigilance and traceability system (declaration or ISO certificate)
- Labeling and instructions (Artwork in English)
- Justification of the classification according to Annex IX
- A copy of ISO certificate/Proof of QMS
- Information on Clinical Investigations
- Additional documentations may be required, dependent on the special characteristics of the device.
All data obtained for Eudamed is provided in accordance with the Medical Device Vigilance System. The efficiency and value of Eudamed has been the subject of strict evaluation, the results of which are available to the public; however, it is expected to be expanded and improved under the NEW Medical Device Regulation.
What’s the role of the Global Medical Device Nomenclature?
The Global Medical Device Nomenclature (GMDN) is an essential tool for Eudamed and a step towards harmonization of the EU Member States. GMDN is a collection of generic descriptions of medical device– agreed internationally – that are used to identify medical devices. Each medical device has a GMDN code attached to it at the point of Notification within Eudamed. This system allows for global operators to identify devices and exchange information pertaining to performance and safety. It is the result of the collaborative work of medical device experts from all over the world and mandated by the European Commission. The GMDN also presents best practice for manufacturers using Eudamed.
If you have any questions about Eudamed, or the compliance of your medical devices with EU regulations, get in touch with Obelis’ regulatory experts today.