In a European context, the MDR and IVDR allow the member states to adopt national rules for the registration of distributors (including pharmacies). In a national context, the German Medical Device Law Implementation Act (MPDG) authorises the Federal Ministry of Health to adopt corresponding rules in an ordinance (Section 88 (1) no. 9 MPDG). Such an ordinance has not yet been published (as of August 2024).

Please note that the BfArM is not responsible for legal matters and therefore cannot provide guidance on this topic.

Please refer to Article 13 of Regulation (EU) 2017/745 and Article 13 of Regulation (EU) 2017/746 for the general obligations of importers under the MDR and IVDR (effective date 26 May 2021 and 26 May 2022):

Laws and regulations

German importers are only required to register in the European database EUDAMED. Further information on the registration can be found on the website of the EU Commission: EUDAMED information centre

In a national context, there is no legal basis and no obligation for importers to register in DMIDS. The role of "importer" refers exclusively to the responsibility described in § 5 MPG and is no longer valid under the current legal situation.

The general obligations of importers are described in Article 13 of the MDR and IVDR.

Please note that the BfArM has no responsibilities in this context. You can find the federal state authority responsible for your company here:

Landesbehörden Inverkehrbringen (authorities of the Länder for placing on the market)

No. If a product is already CE-marked and registered in an EEA member state, it does not have to be notified in Germany in the German Medical Devices Information and Database System additionally.