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.
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
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.
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.
Links to more information
Responsible for editing:Bayerisches Staatsministerium für Umwelt und Verbraucherschutz
- 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