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.

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

European database for medical devices: EUDAMED

MDR and IVDR conceptualize EUDAMED as the central platform for the European exchange of information and data on medical devices. EUDAMED consists of 6 modules: Actors Registration, UDI/Devices, Certificates/Notified Bodies, Vigilance, Clinical Investigations and Performance Studies, and Market Surveillance. However, not all modules are currently (as of August 7, 2023) available.

Please note: Transition rules apply until EUDAMED is fully functional. More information can be found under Transition period until EUDAMED is fully functional.

The EU Commission operates EUDAMED. The EU Commission provides extensive information on its websites in various places and is the contact for all questions related to EUDAMED.

Contact: SANTE-EUDAMED-SUPPORT@ec.europa.eu

Information about EUDAMED on the websites of the EU Commission

Overview

A comprehensive overview is provided by the EUDAMED information center of the EU Commission:

More general information about EUDAMED:

Medical Devices - EUDAMED

Unique Device Identifier (UDI)

Questions related directly or indirectly to the UDI (e.g. UDI assignment, labelling and registration of devices, use of the European Medical Device Nomenclature) are answered by the UDI Helpdesk:

UDI Helpdesk

European Medical Devices Nomenclature (EMDN)

When registering medical devices in EUDAMED, the European Medical Devices Nomenclature (EMDN) must be used. The first version of the EMDN is integrated in EUDAMED. It is available for download at the following link:

European Medical Device Nomenclature

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)

Transition period until EUDAMED is fully functional

EUDAMED is currently (as of August 7, 2023) not yet fully functional. The German Federal Ministry of Health (German: Bundesgesundheitsministerium, BMG) has therefore announced in the Federal Gazette how the various obligations and requirements mentioned in Article 123(3)(d) of the MDR and Article 113(3)(f) of the IVDR and related to EUDAMED, are to be performed.

Official Section of the Federal Gazette (BAnz AT May 28, 2021 B6 und BAnz AT May 27, 2022 B4)

EUDAMED: Registration as economic operator

Manufacturers, authorized representatives and importers based in Germany are already obliged to register in the EUDAMED module Actor Registration. The registration data is validated by the respective competent federal state authority. Afterwards, each economic actor will be assigned a unique number, the Single Registration Number (SRN). You can look up which authority is responsible for you via a table in EUDAMED.

Please note: The German competent federal state authority listed in EUDAMED differ slightly from the authorities in DMIDS. The table in EUDAMED is decisive for the registration in EUDAMED!

DMIDS: Product Notifications, Clinical Investigations and Performance Studies

Notifications of the placing on the market of medical devices (including IVD) as well as applications for approval/notifications of clinical investigations and performance studies continue to be made via the DMIDS.

Notifications of Medical Devices and In Vitro Diagnostics

Please note: Via a voluntary registration of products in the EUDAMED module UDI & Devices you do not fulfill the existing national notification obligations. These must be fulfilled via the DMIDS.

Applications for clinical investigations and performance studies

BfArM website: Reporting of (suspected) serious incidents, recalls and serious adverse events (SAEs).

Notifications of serious incidents and recalls as well as serious adverse events (SAE) continue to be made using the existing (online) forms available on the BfArM websites.

The corresponding forms can be found at Reports and corrective actions.