Medical Devices: Commercial Handling - Notification Unfortunately this specification of service has not yet been completely translated.

If you want to handle medical devices commercially, you must report this to the German Institute for Medical Documentation and Information.

Medical devices are instruments, apparatus, devices, software and substances (or preparations of substances) that are intended for human use

  • the detection, prevention, monitoring, treatment or alleviation of diseases;
  • the detection, monitoring, treatment, alleviation or compensation of injuries or disabilities,
  • the examination, replacement or modification of the anatomical structure or a physiological process, or
  • the regulation of conception

serve.

Who

  • places medical devices or in vitro diagnostic medical devices on the market for the first time,
  • Medical devices prepared exclusively for others that are intended to be used with low germs or sterile,
  • composes systems or treatment units, or
  • medical devices sterilized,

must notify the competent authority there of this.

On the DIMDI website, you will find out which documents and information are necessary for the initial notification of change or revocation.

Related Links

  • DIMDI - Wegweiser Notification Obligation

Notifications must be made via DIMDI's online registration system.

Related Links

  • DIMDI - Ads

Hints

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.

  • LAsD - Safety of Medical Devices
  • § 25 Act on Medical Devices (Medical Devices Act - MPG),
  • Medical Devices Ordinance (Medical Devices Regulation - MPV),
  • Ordinance on the database-supported information system on medical devices of the German Institute for Medical Documentation and Information (DIMDI Regulation - DIMDIV).

Related Links

  • § 25 MPG
  • MPV
  • DIMDIV

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