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

Each medical device must be registered by the manufacturer in the European Commission's UDI database before being placed on the market. In future, this product registration is to be handled via the European medical device database EUDAMED. For this purpose, one of the six planned EUDAMED modules for Unique Device Identification (UDI) and product registration is envisaged.

As this module is currently not yet functional, the Federal Ministry of Health has issued a notice regulating the transitional period until EUDAMED is fully functional for product registration as follows:

The registration of products that comply with Regulation (EU) 2017/745 as well as systems and treatment units is carried out via the German Medical Devices Information and Database System (DMIDS) in accordance with Section 96 (1) MPDG.

Procedure

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

  • New notification
  • In process
  • Data stock

Special notes

The Bavarian State Ministry of Health and Care is responsible for monitoring the placing on the market of non-active medical devices, and the governments of Upper Bavaria and Upper Franconia (pharmaceutical departments) are responsible 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: 05.11.2021

Responsible for editing: Bayerisches Staatsministerium für Umwelt und Verbraucherschutz

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