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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.
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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.
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Regierung der Oberpfalz - Dezernat 4 - Kompetenzzentrum Marktüberwachung
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Emmeramsplatz 8
93047 Regensburg
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Emmeramsplatz 8
93047 Regensburg
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Description
Every 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 processed via the European medical device database EUDAMED. For this purpose, one of the six planned EUDAMED modules is intended for unique device identification (UDI) and product registration.
As this module is currently not yet functional, the Federal Ministry of Health has issued the following announcement regarding the transitional period until EUDAMED is fully functional for product registration:
The registration of devices that comply with Regulation (EU) 2017/745 and of systems and treatment centers is carried out in accordance with Section 96 (1) MPDG via the German Medical Device Information and Database System (DMIDS).
Proceedings
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.
Related links
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Marktüberwachung - Aufgaben und Befugnisse der BehördenInformationen der Bayerischen Gewerbeaufsicht
Related issues
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Medical devices; application for a certificate of free saleFor the export of a medical device, manufacturers can apply for a certificate of marketability of the medical device in Germany (certificate of free sale).
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Medical devices; monitoring of operatorsThe trade supervisory authorities inspect the operation of medical-technical devices.
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Technical consumer protection; market surveillance of active medical devices
The task of the Trade Supervisory Office at the Government of Upper Palatinate is to ensure safe products in the area of technical consumer protection. This includes active medical devices (dependent on an energy source).
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Technical consumer protection; market surveillance Ecodesign / energy consumption labeling
The Trade Supervisory Office at the Government of Swabia is responsible for monitoring environmentally friendly design (ecodesign) and energy consumption labeling.
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Technical consumer protection; market surveillance of in-vitro diagnostics
The task of the Trade Supervisory Office at the Government of Upper Palatinate is to ensure safe products in the area of technical consumer protection. This includes active (energy-dependent) in-vitro diagnostics.
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Technical consumer protection; registration of economic operators
Manufacturers, authorized representatives and importers (importers) of medical devices must register via the electronic system for the registration of economic operators (EUDAMED) before placing a product on the market.
Status: 02.12.2024
Editorially responsible for prodecure description: Bayerisches Staatsministerium für Umwelt und Verbraucherschutz
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