BfArM - Federal Institute for Drugs and Medical Devices

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417 results

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How can an acceleration or prioritisation of the assessment of a variation procedure be requested from BfArM, and what information is required? Date: 05. November 2025 Topics: Licensing Type: FAQ

Generally, applications are processed in the order in which they are received. Exceptions to this rule may be made in justified cases if this leads to an improvement in an existing critical supply situation or if it can avert a critical supply …

Are variations to purely national licences that contain only one single change but several marketing authorisations regarded as a grouping? Date: 03. July 2025 Topics: Licensing Type: FAQ

Yes. These variations are categorised as “horizontal groupings” according to Article 13.d.2) of Regulation 712/2012/EC. However, when submitting such variations to the BfArM they should not be submitted as a grouping but as a collective notification …

How are the data on antibiotic resistance in section 5.1 of the SmPC to be updated? Date: 10. June 2025 Topics: Licensing Type: FAQ

Data on the resistance situation of systemically available antibiotics in Germany is regularly reassessed in the Z.A.R.S. project and is considered in the resistance table for Section 5.1 of the SmPC.

The previously requested EUCAST table (European …

Is it allowed to register my trial in DRKS if it is already registered in another WHO Primary Registry (e.g. CTIS)? Date: 07. April 2025 Topics: About BfArM Type: FAQ

WHO recommends that clinical trials with one or more recruitment sites in the same country should be registered in only one study registry. For more information, please visit the WHO website.

If you still wish to register in the DRKS (e.g. because …

How is the reference to the digital package leaflet implemented for centrally authorised medicinal products? Date: 17. February 2025 Topics: Licensing Type: FAQ

The European Medicines Agency (EMA) is the competent authority for centrally authorised medicinal products. The BfArM recommends to contact the EMA in case of questions.

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.

How are § 23b studies being processed under the MDR / MPDG? Date: 14. June 2024 Topics: Medical devices Type: FAQ

A preliminary remark:

In order to avoid misunderstandings, it should be noted that the term "other clinical investigation", which has been used in practice up to now, is not legally defined. As a rule, this refers to clinical investigations of …

What legal basis do I have to consider for the reprocessing of medical devices in practice? Date: 28. May 2024 Topics: Medical devices Type: FAQ

Basically, according to § 8 of the Medical Device Operator Ordinance (MPBetreibV), proper reprocessing is presumed if the recommendation of the Robert Koch Institute and the BfArM on hygiene requirements for the reprocessing of medical devices (RKI-

E.2. How and when are applications for exemptions pursuant to Section 31 sub-section 1 sentence 2 AMG or applications for suspension of the 3-year period in accordance with Section 31 sub-section 1 number 1 AMG to be submitted? Date: 13. May 2024 Topics: Licensing Type: FAQ

An electronic application portal for exemptions and suspensions to the sunset clause was developed which should be used for submitting such applications. We expressly request to use this electronic procedure as opposed to conventional applications.

Is an application for determination of regulatory status, classification or categorisation of a product according to § 6 para. 1 or 2 MPDG associated with costs? Date: 04. May 2024 Topics: Medical devices Type: FAQ

Yes, fees are charged for a decision pursuant to § 6 para. 1 or 2 MPDG on the classification, determination of the regulatory status or categorisation of products in accordance with § 1 BGebG in conjunction with § 10 Table 2 No. 1 of the Annex to § 2 …

Does the BfArM maintain a list of general classifications of medical devices? Date: 04. May 2024 Topics: Medical devices Type: FAQ

The BfArM does not maintain a list of general classifications, since the examination of each individual product is conducted on a case-by-case basis, taking into account the respective intended use (e.g. instructions for use, advertising materials, …

In what form can applications for determination of the regulatory status, classification or categorisation of a product be submitted in accordance with § 6 para. 1 or 2 MPDG? Date: 04. May 2024 Topics: Medical devices Type: FAQ

Applications in accordance with § 6 para. 1 and 2 can be submitted informally. This should be done electronically as PDF file(s) by e-mail to mp-klar@bfarm.de . Please …

What are the risk classes medical devices are divided into? Date: 04. May 2024 Topics: Medical devices Type: FAQ

Medical devices are assigned to risk classes. With the exception of in vitro diagnostic medical devices, medical devices are classified according to the classification rules in Annex VIII MDR. The products are divided into four classes I, IIa, IIb …

In which case can an application for determination of the regulatory status, classification or categorisation of a product be submitted in accordance with § 6 para. 1 or 2 MPDG? Date: 04. May 2024 Topics: Medical devices Type: FAQ

In the event of dispute between the manufacturer and its notified body, the manufacturer with a registered place of business in Germany or its notified body are entitled to submit an application in accordance with § 6 para. 1 MPDG.

The authority of …

What documents must be submitted to the BfArM for applications to determine the regulatory status, classification or categorisation of the product in accordance with § 6 para.1 or 2 MPDG? Date: 04. May 2024 Topics: Medical devices Type: FAQ

Formulate your application as an informal, signed application in accordance with § 6 para. 1 or § 6 para. 2 no. 1-3 MPDG and please specify which decision is to be made regarding your product.

To enable a proper decision to be made, please enclose …

Where can I find information on the regulatory status, classification or categorisation of medical devices? Date: 04. May 2024 Topics: Medical devices Type: FAQ

Other sources can be used for decision-making such as the documents of the European Commission, which you can access at

https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en

The …

What is meant by "determination of regulatory status"? Date: 04. May 2024 Topics: Medical devices Type: FAQ

The BfArM decides on the regulatory status (formerly "demarcation") of a device as a medical device or accessory to a medical device, or the regularory status of a device as a product listed in Annex XVI of Regulation (EU) 2017/745 upon application …

What is meant by a decision on the "categorisation of a product" in class I? Date: 04. May 2024 Topics: Medical devices Type: FAQ

The BfArM decides on the categorisation of a class I device as follows upon application in accordance with § 6 para. 2 MPDG
a) reusable surgical instrument,
b) device that is placed on the market in a sterile condition or
c) device with measuring …

I am a manufacturer and do not know whether my product is a medical device. How do I proceed? Date: 04. May 2024 Topics: Medical devices Type: FAQ

The classification of a device as a medical device is determined by the manufacturer with the intended purpose for which the device is intended according to the information on the label, in the instructions for use or in the promotional or sales …

Does the BfArM make decisions on a class of similar products? Date: 04. May 2024 Topics: Medical devices Type: FAQ

No, that is not possible. Under the conditions mentioned above, the BfArM can decide on the regulatory status, classification or categorisation of individual specific products only, not on a class of products.