Service Center Medical Devices

Here you will find relevant links to authorities, organisations, institutions and associations in the field of medical devices.

The list is not exhaustive in the areas specified.

BMG - Department

Federal Ministry of Health (BMG)
BMG is responsible for the legal foundations for the protection of human health, provided they do not come under the state's line of duty.

Federal Institute for Drugs and Medical Devices (BfArM)
The authorisation of medicinal products, registration of homeopathic drugs, evaluation of the side effects of drugs and medical devices, as well as legal traffic control of narcotics are some of the main tasks of BfArM.

Paul-Ehrlich-Institute (PEI), Federal Institute for Vaccines and Biomedicines
PEI is responsible for the authorisation and regular inspections of vaccines, sera, immune diagnostics, products derived from human blood or plasma, as well as the risk evaluation of in vitro diagnostics.

Organisations, Institutions, Associations

German Institute for Standardisation e.V. (DIN)
Since 1975 DIN has been recognized by the German government as the national standards body and represents German interests at international and European level.

German Medical Technology Association e.V. (BVMed)
The German Medical Technology Association (BVMed), a trade association from the medical device industry domain.

European Commission - Consumer Affairs - Medical Devices
Information on legislation, directives etc. concerning medical devices

European Diagnostic Manufacturers Association (EDMA)
EDMA represents the European in vitro diagnostics/medical laboratory tests industry. You can request information on the EDMS classification.

emtec e.V.
A non-profit Institute for Scientific Counselling and Advanced Training in Medical Technology.

MedTech Europe
MedTech Europe represents manufacturers and associations in the field of medical devices troughout Europe.

U.S. Food and Drug Administration (FDA)
The FDA is an U.S. American organisation of public health working for consumer protection in the field of foods, cosmetics, drugs, medical devices etc. Medical Device Reporting (MDR) and Recall Reports are issued on medical devices.

International Medical Device Regulators Forum (IMDRF)
The International Medical Device Regulators Forum (IMDRF) is a world-wide collaboration of regulatory authorities and industry with the objective to harmonise the regulations in the medical device field. This forum takes over the responsibilities from the former Global Harmonization Task Force (GHTF)

Association of the Diagnostics Industry (VDGH)
VDGH is a trade association of corporations from the field of laboratory diagnostics.

Working Committee for Medical Technology Berlin-Brandenburg (AMBB)
Open Working Committee of medical technology specialists.

Working group of the medical ethics committees in the Federal Republic of Germany
Working group of the medical ethics committees.

Producers of Nomenclatures and Catalogues for Medical Devices

HOSPIMED Informations-Datenbanken
Information systems for companies on the subjects medical technology, services and facilities, laboratory and chemical analysis, rehabilitation, nursing and medical devices.

Seibt Industrie-Informationen
Information on companies, products and services in the field of medical devices, Seibt-Online-Database

ECRI Institute
Producer of Universal Medical Device Nomenclature System (UMDNS)