Technical consumer protection; registration of active medical devices

Manufacturers who wish to place active medical devices on the market must first provide them with a Unique Device Identification (UDI) and register them in the UDI database.

Description

Procedure

The German Medical Devices Information and Database System (DMIDS) is divided into various individual areas. A separate area is available for the notification of medical devices (transitional provision according to § 96 MPDG with reference to § 25 MPG). Each area consists of three components:

  • New notification
  • In progress
  • Database

Special notes

The Bavarian State Ministry of Health and Care is responsible for monitoring the placing on the market of non-active medical devices, as are the governments of Upper Bavaria and Upper Franconia (Pharmacy departments) as enforcement authorities.

Online procedures

  • Deutsches Medizinprodukte-Informations- und Datenbanksystem (DMIDS)

    The information system on medical devices enables the recording, processing and online transmission of notifications and applications by notifying parties/applicants, sponsors, ethics committees, notified bodies and competent authorities.
    An individual access authorization is required to access the information system. This must be applied for.

Status:13.11.2023

Responsible for editing:Bayerisches Staatsministerium für Umwelt und Verbraucherschutz

Contains machine translated content. Show the original content

  • Online transactions, Bavaria-wide
  • Online transactions, locally limited
  • Form, Bavaria-wide
  • Form, locally limited
  • Prefillable Form, Bavaria-wide
  • Legal bases, Bavaria-wide
  • Legal bases, locally limited
  • Fees, Bavaria-wide
  • Fees, locally limited
Bild zur Leistungsbeschreibung

Responsible for you

If you select a location under "Localization" the contact details of the responsible authority and, if applicable, locally valid information will be displayed.