Eudamed
In accordance with the new European regulations on medical devices (Article 33 of Regulation (EU) 2017/745, ‘MDR’) and in vitro diagnostic medical devices (Article 30 of Regulation (EU) 2017/746, ‘IVDR’), the European Commission is currently setting up a European database on medical devices, EUDAMED. The MDR and IVDR require EU Member States and economic operators to register and update data on medical devices centrally in EUDAMED.
EUDAMED objectives
- strengthening market surveillance;
- providing fast access to information on manufacturers, authorised representatives, devices and certificates;
- providing vigilance data; enabling central sharing of information;
- contributing to transparency.
For more information on EUDAMED and the registration of medical devices and in vitro diagnostic medical devices, please visit the EU website: Medical Devices - EUDAMED (europa.eu
EUDAMED Q&A
-
I am a Netherlands-based compiler, manufacturer, manufacturer’s authorised representative or importer. When does the law require me to complete registration in EUDAMED?
Once the European Commission announces that EUDAMED is fully operational, you will have another 6 months to register as an actor ...
-
I am a Netherlands-based manufacturer or this manufacturer’s authorised representative. If I choose to register an actor and product for Class I medical devices and IVD in EUDAMED, will I also be required to submit a notification via NOTIS in order to comply with national legislation?
No. The government recognises information on Class I medical devices and IVD registered in the EUDAMED modules that have been ...
-
What is EUDAMED?
EUDAMED is the European database for medical devices that all EU Member States are required to use. This database contains ...
-
Do manufacturers or EU authorised representatives have access to EUDAMED?
Yes. There is a protected version in which economic operators register data centrally. There is also a public version of Eudamed ...