BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Search i

Search help

  • Enter one or more search terms in the search field. Upper and lower case are not relevant.
  • As soon as you have entered three letters in the search field, various search words will be suggested from which you can choose one.
  • If you are searching for a certain group of words, put these words in double quotes. The hits will then contain the words in the order you entered, e.g. "medicines for children".
  • Multiple search terms can also be combined with the Boolean operators AND and OR. When using the operator AND, the results contain the intersection of all search terms. When using the operator OR, the hits contain one of the search terms or only individual search terms. The result set is therefore significantly larger. Please note that these operators must be written in capital letters.

  • If you receive a (too) large number of hits as a result of your search, you can narrow it down by using filters. These filter options appear to the left of the search results and are subdivided into:

    • category (e.g. safety of medicinal products, medical devices, code systems)
    • format (e.g. download, risk information, DHPCs)
    • time interval (e.g. last 30 days, older than ...)
  • Selected filters can be removed individually or all at once ("Show all results").
  • By default, search results are sorted by relevance, but they can also be sorted chronologically ("Latest entries first" or "Oldest entries first").

Enter search term

14,965 results

Filter

Results per page: 10 20 30

Sorting:

Latest entries first

Relevance

Latest entries first(selected sorting)

Oldest entries first

Selected filter

Reporting Recalls Date: 17. August 2022 Topics: Medical devices Type: Article

Reporting Recalls

SAE reporting for performance studies Date: 17. August 2022 Topics: Medical devices Type: Article

SAE reporting for performance studies

Which SAE and DD reporting obligations apply from the date of application of the MDR in Germany? Date: 17. August 2022 Topics: Medical devices Type: FAQ

Information on SAE and DD reporting requirements can be found in the Applications and Reports section.

SAE and DD reporting for clinical investigations

Substantial modifications Date: 17. August 2022 Topics: Medical devices Type: Article

Substantial modifications to a performance study must be notified to the competent ethics committee and the competent federal higher authority in accordance with Article 71 of the European Regulation 2017/746 (IVDR), and Section 54 of the Medical …

Request for authorisation of a performance study Date: 17. August 2022 Topics: Medical devices Type: Article

Performance studies of in vitro diagnostic devices (IVDs) that are not intended solely for research purposes and where the investigational device either may not yet bear a CE mark or its use in the performance study is outside its intended purpose …

Evaluation vnd.openxmlformats-officedocument.wordprocessingml.document, 25KB, File does not meet accessibility standards Date: 17. August 2022 Topics: Medical devices Type: Download

Summary evaluation of serious adverse events (SAEs) and device deficiencies (DDs)
Report template version 4, 2021-06-25

Request for authorisation of a clinical investigation Date: 17. August 2022 Topics: Medical devices Type: Article

Clinical investigations of medical devices that are conducted as part of the clinical evaluation for conformity assessment purposes and where the investigational device either may not yet bear a CE mark or its use in the clinical investigation is …

Annex 3.1 complication rates vnd.openxmlformats-officedocument.spreadsheetml.sheet, 43KB, File does not meet accessibility standards Date: 17. August 2022 Topics: Medical devices Type: Download

SAE and DD complication rates within clinical investigations or performance studies
Table version 4, 2021-06-25

Notes PDF, 485KB, File does not meet accessibility standards Date: 17. August 2022 Topics: Medical devices Type: Download

Notes on completing the summary evaluation of serious adverse events (SAEs) and device deficiencies (DDs)
Version 4, 2021-06-25

Is there a transition period for applications for authorisation of a clinical investigation of medical devices? Date: 17. August 2022 Topics: Medical devices Type: FAQ

In Germany, the legislation provides for a cut-off date for the transition to the new legislation for clinical investigations of medical devices. This means that all applications must be submitted and processed according to the legislation valid …