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
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).
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
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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.
Links to more information
Status:13.11.2023
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
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