FAQ Medical Devices Import to Germany
No, BfArM cannot provide any information on the authenticity or validity of certificates.
Some notified bodies provide "certificate databases" on their websites for general search. Please check the certificates yourself in the public database of the notified body that issued it.
If that is not sufficient, please directly contact the notified body. Only they can confirm the authenticity and validity with certainty. Contact information on the European notified bodies can be found on the websites of the European Commission:
The European authorized representatives are responsible for the registration as well as the compliance with all requirements for the first placing on the EU market. The authorized representative should be named on the packaging and package leaflet.
In Germany, the registration of a medical device can be proved by an extract from the Medical Devices Information System. Please note that it is not a signed nor stamped document.
You can search for the registration by yourself in the public database for a small fee, provided that the authorized representative/importer is located in Germany
Alternatively or additionally, you could contact the responsible competent authority for the authorized representative.
Information on COVID-19 at the European Commission
In the subsequent document, you will find the most frequent questions and answers in connection with medical devices and coronavirus, summarized by the European Commission:
Further up-to-date information is available on the Commission website. To be actively informed, you can sign up for a newsletter there:
List of relevant links
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
A non-profit Institute for Scientific Counselling and Advanced Training in Medical Technology.
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 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
Producer of Universal Medical Device Nomenclature System (UMDNS)