Medical devices are products with a medical purpose, intended by the manufacturer for human use. Unlike medicinal products, which have a pharmacological, immunological or metabolic action, the main intended action of medical devices is primarily achieved by physical means, for example.

Medical devices include, for example, implants, products for injection, infusion, transfusion and dialysis, human medical instruments, medical software, catheters, pacemakers, dental products, dressings, visual aids, X-ray equipment, condoms, medical instruments and laboratory diagnostics. Medical devices are also products containing or coated with a substance or preparations of substances which, when used separately, are considered to be medicinal products or constituents of medicinal products (including plasma derivatives) and are capable of exerting an effect on the human body in addition to the functions of the product. The legal definition of medical devices applicable throughout Europe is contained in Article 2 No. 1 of Regulation (EU) 2017/745 (Medical Device Regulation, MDR).

The tasks of the BfArM in the area of medical devices result from the MDR, the Medical Devices Law Implementation Act “Medizinprodukterecht-Durchführungsgesetz” (MPDG), the Medical Devices Act, “Medizinproduktegesetz” (MPG) and the further implementing legal ordinances. Moreover, BfArM performs tasks from the Fifth Book of the German Social Code “Sozialgesetzbuch” (SGB V) in the area of digital health applications “Digitale Gesundheitsanwendungen” (DiGA).

A major focus of the BfArM's tasks with regard to medical devices is the evaluation of reports on so-called "serious incidents". These are events, that occur with medical devices, that are already on the market with regular CE marking, and where a product defect is considered to be the cause of a death or a serious deterioration in the state of health of, for example, a patient.

The BfArM receives these incident reports from users (e.g. doctors, clinics) and manufacturers of medical devices. It then carries out a risk assessment of the serious incident. If the BfArM comes to the conclusion, that changes to the product are necessary for safety reasons and the manufacturer does not already arrange for this in accordance with his own legal responsibility, the BfArM issues a recommendation to the manufacturer or the state authority responsible for monitoring. The latter authorities essentially have the legal possibilities to order these recommendations if necessary and to monitor their implementation. In cases of imminent danger, the BfArM also has its own possibilities to issue orders to protect the health or safety of patients, users or other persons.

The BfArM is also responsible for approving clinical investigations of medical devices. A clinical investigation is conducted on volunteers, to collect data on aspects of the safety and/or performance of a medical device, that can only be verified in clinical practice. Such an investigation is required, when clinical data from the literature, from clinical experience or from previously conducted clinical investigations are not sufficient.

BfArM also decides on the classification of individual medical devices and their differentiation from other devices upon application by a competent state authority (“Landesbehörde”), a Notified Body or the manufacturer.
In the case of digital health applications (DiGA), BfArM decides on the inclusion of a DiGA in the public DiGA list of the BfArM, and thus on the reimbursability by the statutory health insurance in Germany, upon application in accordance with the requirements of §33a and §139e of the Fifth Book of the Social Code (“Sozialgesetzbuch”) (SGB) and the supplementary legal ordinance.
The BfArM also operates the German Medical Devices Information and Database System (DMIDS), as a national portal for many notifications and applications in the field of medical devices, as well as a related interface to the European medical devices database EUDAMED, among others.