BfArM - Federal Institute for Drugs and Medical Devices

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Import to Germany

Can BfArM validate the authenticity of certificates for medical devices?

No, BfArM cannot provide any information on the authenticity or validity of certificates.

What are the registration obligations of importers according to the transitional provisions of § 96 MPDG in reference to the Medical Devices Act (MPG)?

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.

What are the registration obligations of importers according to MDR and IVDR?

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.

Laws and Ordinances

European Market

Do importers have to notify the registration of a medical device that is already registered in a member state of the European Economic Area to the German authorities?

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 German Medical Devices Information and Database System (DMIDS) to sell in Germany.

How can I check and prove the validity of a certificate?

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:

Notified Bodies for active implantable medical devices

Notified Bodies for medical devices

Notified Bodies for medical devices (MDR)

Notified Bodies for in vitro diagnostic medical devices