responsibility finder
Schleswig-Holstein

Register as an economic operator of medical devices and/or in vitro diagnostic medical devices

Source: Zuständigkeitsfinder Schleswig-Holstein (Linie6PLus)

Service Description

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.


Process flow
  • 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
Requirements
  • They must be based in Schleswig-Holstein.
  • The medical devices must bear a CE marking.
What are the fees?

Administration fee: 30,00 EUR
Payment in advance: No
https://www.gesetze-rechtsprechung.sh.juris.de/bssh/document/jlr-VwGebVSH2018rahmen/part/X
Fee Schedule 9: Fees for receiving and checking the information submitted by the economic operator for registration.

What deadlines do I have to pay attention to?

Before starting work.

Processing duration

Processing time: 1 - 2 Months
If all requirements are met, the average processing time is between 1 and 2 months.

Legal basis
Appeal

- Contradiction

What else should I know?

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".

Author

The text was automatically translated based on the German content.

Technically approved by

Ministry of Justice and Health of the State of Schleswig-Holstein

Professionally released on

12.10.2023

Process flow

  • 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

Requirements

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

What are the fees?

Administration fee: 30,00 EUR
Payment in advance: No
https://www.gesetze-rechtsprechung.sh.juris.de/bssh/document/jlr-VwGebVSH2018rahmen/part/X
Fee Schedule 9: Fees for receiving and checking the information submitted by the economic operator for registration.

What deadlines do I have to pay attention to?

Before starting work.

Processing duration

Processing time: 1 - 2 Months
If all requirements are met, the average processing time is between 1 and 2 months.

Legal basis

Appeal

- Contradiction

What else should I know?

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".

Author

The text was automatically translated based on the German content.

Technically approved by

Ministry of Justice and Health of the State of Schleswig-Holstein

Professionally released on

12.10.2023

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