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Direct Healthcare Professional Communication (DHPC) on metamizole-containing medicines: Important measures to minimise the serious outcomes of known risk of agranulocytosis PDF, 234KB, File does not meet accessibility standards Date: 09. December 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: metamizole

The marketing authorisation holders of metamizole-containing medicinal products provide information on the early symptoms of agranulocytosis.

Direct Healthcare Professional Communication (DHPC) on Cyanokit 5 g powder for solution for infusion: Potential microbial contamination of certain batches PDF, 214KB, File does not meet accessibility standards Date: 09. December 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: hydroxycobalamin

The company SERB SA informs about a potential microbial contamination and a possible resulting risk of infection.

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 …

Direct Healthcare Professional Communication (DHPC) on 5-Fluorouracil (i.v.): In patients with moderate or severe renal impairment, uracil levels measured to determine dihydropyrimidine dehydrogenase (DPD) deficiency should be interpreted with caution. PDF, 338KB, File does not meet accessibility standards Date: 24. October 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: 5-fluorouracil

The marketing authorisation holders of 5-fluorouracil containing medicines would like to inform that in patients with moderate or severe renal impairment, blood uracil levels used for dihydropyrimidine dehydrogenase (DPD) phenotyping should be …

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 …