Wirtschaftsakteur von Medizinprodukten und/oder In-vitro-Diagnostika registrieren

Manufacturers, authorized representatives and importers based in Germany are obliged to register in EUDAMED or DMIDS.

Before manufacturers, authorized representatives, importers or responsible persons who have manufacturing obligations under EU law place a medical device or in vitro diagnostic medical device on the market, they must register with both EUDAMED and the German Medical Devices Information and Database System (DMIDS).

For technical reasons, manufacturers of systems and treatment centers (SPPP) are required to register in the EUDAMED "Actor Module".

According to the Medical Devices Implementation Act (MPDG), the following must also be registered with DMIDS

• Companies and facilities that reprocess devices that are intended to be used aseptically or sterile exclusively for others, or healthcare facilities that reprocess single-use devices or have them reprocessed, unless they are obliged to register.
• Establishments and facilities that manufacture class III implantable custom-made devices

All persons responsible for regulatory compliance (PRRC) must be registered in EUDAMED; registration of the safety officer is no longer required in DMIDS since 26.05.2022.

The terms medical devices and in vitro diagnostic medical devices are defined in the legal basis for action.

• They must be based in Schleswig-Holstein.
• The medical devices must bear a CE marking.

• You complete the registration application in EUDAMED or DMIDS.
• The State Office for Social Services is automatically informed of the application, validates the data and approves the application if the assessment is positive.
• When an application is submitted via EUDAMED, the economic operator is assigned a unique number, the Single Registration Number (SRN).
• The notifications in DMIDS are registered automatically

Before starting work.

The State Office for Social Services (LAsD), Health Protection Department, is responsible for the "Safety of Medical Devices" in Schleswig-Holstein. Further information can be found on the LAsD website.

Further information on the notification obligations of economic operators under MDR, IVDR and the MPDG in the DMIDS and EUDAMED systems can be found on the website of the Federal Institute for Drugs and Medical Devices under "Europe and EUDAMED".

- Contradiction

• Notification of commercial handling of medical devices Transmission
• Registration of economic operators
• First-time placing on the market of medical devices and in vitro diagnostic medical devices requires registration
• Economic operators are registered both centrally in EUDAMED and in the German Medical Device Information and Database System (DMIDS)
• Responsible: State Office for Social Services in Schleswig-Holstein