FAQ Medical Devices Import to Germany
No, BfArM cannot provide any information on the authenticity or validity of certificates.
There is a possibility of registering "importers" in the sense of the German Medical Devices Act (MPG), however, we want to point out the definition in § 5 MPG. It is stated there that the importer is the responsible person if medical devices are not imported into the European economic area under the responsibility of the authorized representative. Thus, the responsibilities are similar to those of an authorized representative. Please inform yourself on the resulting legal obligations.
BfArM cannot advise you in this regard.
Please refer to Article 13 of Regulation (EU) 2017/745 for the general obligations of importers under the MDR (effective date 5/26/2021). The effective date of the IVDR is 5/26/2022.
Under the new MDR and IVDR regulations, there is an obligation for importers to register exclusively in the European database EUDAMED. More information can be found on the website of the EU Commission.
No, it is not necessary to register products in Germany that are already registered in a member state of the European Economic Area. European importers or authorized representatives based outside of Germany do not have to notify in the Medical Devices Information System to sell in Germany.
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:
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)