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 (