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As a manufacturer of medical devices, what do I have to bear in mind when I want to launch a new medical device on the German market? Date: 04. December 2024 Topics: Medical devices Type: FAQ

Basic information on getting started in the medical device field and launching medical devices is explained at Basic information.

The monitoring of the manufacture, placing on the market and circulation of medical devices (including their operation …

We are a foreign manufacturer of medical products and would like to market our medical products in Germany as well. Is our CE mark also valid in Germany? Date: 04. December 2024 Topics: Medical devices Type: FAQ

If you have a CE mark for your medical product that is valid for the European market, you can also market the product in Germany.

More information:

FAQ: Do distributors or importers have to notify the distribution of medical devices that are …

We are manufacturers of medical products and require export certificates. Can you provide us with these? Date: 04. December 2024 Topics: Medical devices Type: FAQ

Many countries, such as Colombia or Pakistan, allow the marketing of products that have already been approved for the European market. Therefore, manufacturers must be able to prove that their products can be legally marketed there. These …

Do distributors or importers have to notify the distribution of medical devices that are already registered in the European Economic Area in Germany? Date: 22. October 2024 Topics: Medical devices Type: FAQ

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.

Do importers have to register with DMIDS? Date: 22. October 2024 Topics: Medical devices Type: FAQ

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 …

What other obligations for importers arise from the MDR and IVDR? Date: 22. October 2024 Topics: Medical devices Type: FAQ

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 …

Are there general registration obligations for distributors (e.g. pharmacies)? Date: 22. October 2024 Topics: Medical devices Type: FAQ

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 …

Can the package leaflet refer to a digital package leaflet? Date: 26. June 2024 Topics: Licensing Type: FAQ

Yes, according to the CMDh position papier on the use of mobile scanning of package leaflets and labelling, the following options are available:

  1. A website of the national regulatory authority
  2. Dedicated pages set up by the marketing authorisation …

Can the reference to the digital package leaflet for national marketing authorisations be included as part of a type IA variation or must it be submitted with a type IB variation? Date: 26. June 2024 Topics: Licensing Type: FAQ

The submission can either be made via a so-called "P-Procedure", as only the package leaflet is affected, or as an additional change ("editorial change") in the context of a type IB or type II variation concerning the product information.