BfArM - Federal Institute for Drugs and Medical Devices

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Tasks of the BfArM

in the area of medical devices

The tasks of BfArM in the field of medical devices result in particular from the Medical Device Regulation (MDR) (EU) 2017/745, the Medical Device Law Implementation Act, the “Medizinprodukterecht-Durchführungsgesetz” (MPDG), the Medical Devices Act “Medizinproduktegesetz” (MPG) and the further implementing legal ordinances. In addition, the BfArM performs tasks from the Fifth Book of the German Social Code (“Sozialgesetzbuch”) (SGB V), for Digital Health Applications (“Digitale Gesundheitsanwendungen”) (DiGA).

Contact persons

Contact details from the medical devices division can be found here.

To the contact persons

FAQ

Clinical investigations and performance studies

The BfArM is responsible for approving clinical investigations of medical devices and performance studies of in vitro diagnostic medical devices.

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Risk assessment

The Federal Institute for Drugs and Medical Devices (BfArM) provides information about risks arising from the use or the application of medical devices and the measures appropriate for protection against risks.

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Differentiation and Classification

Medical devices, other than in vitro diagnostic devices and active implantable medical devices, are assigned to risk classes. The classification is done according to the classification rules of Annex VIII of (EU) 2017/745 (Medical Device Regulation, MDR). The products are subdivided into four risk classes I, IIa, IIb and III.

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DiGA and DiPA

Digital applications are an important element in the digital modernisation of health care and nursing in Germany. They are part of the future eHealth infrastructure and will interact closely with other digital elements such as the electronic health record (ePA).

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German Medical Devices Information and Database System (DMIDS)DMIDS

Extensive information is required for the market surveillance of medical devices in Germany. BfArM has set up an information system for medical devices according to § 86 MPDG (formerly § 33 MPG) that enables online-based data entry and editing by persons reporting, sponsors, notified bodies and the competent authorities.

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Further tasks

In addition to its regulatory tasks, BfArM carries out various projects and develops algorithms and AI-based methods to support the risk assessment.

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Corona Pandemic

Here, you find detailed information on the use of masks and visors as well as links for information on antigen-tests for direct pathogen detection of corona virus SARS-CoV-2.

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