Here you will find a compilation of websites on which the EU Commission provides information on the European regulations 2017/745 (MDR) and 2017 /746 (IVDR), on current topics in the European medical device sector, and specifically on the European medical device database EUDAMED.

Common goal: Safe care with medical devices

The implementation of the regulations on medical devices MDR and IVDR was the topic of a workshop organised by the authorities responsible for medical devices in the EU on 10th of July 2024. At the end of the meeting, the heads of the authorities signed an open letter to the European Commission, calling on it to prioritise the implementation of the EU Medical Devices Regulations. Read more

European regulations and their implementation

As of May 26, 2021 and 2022, the European regulations for medical devices and in vitro diagnostic medical devices, are directly applicable law in the EU.

Laws and ordinances

Further information on the European regulations and their implementation as well as on the European database for medical devices EUDAMED can be found on the websites of the European Commission:

General overview "New Regulations"

Guidance of the Medical Device Coordination Group (MDCG) on the implementation of MDR and IVDR

Searchable in the public part are currently:

• all registered economic operators (module Economic Operators)
• voluntarily entered products including UDI information (module Devices/SPPs)
• voluntarily entered certificates (module Certificates) through notified bodies

European database for medical devices: EUDAMED

EUDAMED is the European database for medical devices (including in vitro diagnostic medical devices). Detailed information can be found here.

Read more

Institutions in the European Economic Area (EEA)

For manufacturers and their authorised representatives who wish to notify their products in other EEA Member States, the Directorate-General for Health and Food Safety at the European Commission provides a list with address and contact details of the competent institutions. For Germany, these are BMG, BfArM, PEI and ZLG. All competent institutions in Germany are listed at Competent authorities and ethics committees.

Notified Bodies are nationally accredited bodies that examine the conformity evaluation of the production process completed on behalf of the manufacturers and whose correctness is certified according to uniform assessment factors. Overview of the notified bodies: Notified Bodies