BfArM - Federal Institute for Drugs and Medical Devices

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Information Iris Webinar - January 2026 PDF, 129KB, File is accessible Date: 20. November 2025 Type: Download

Information Iris Webinar - January 2026

Official Launch of Iris Version 6 Date: 20. November 2025 Topics: Kodiersysteme Type: News

Please save the date for the launch webinar on January 28, 2026, at either 10:00 CET or 17:00 CET.

Structure of the BfArM in text form PDF, 172KB, File is accessible Date: 05. November 2025 Topics: About BfArM Type: Download

Structure

Structure of the BfArM PDF, 135KB, File does not meet accessibility standards Date: 05. November 2025 Topics: About BfArM Type: Download

Structure

Iris version 6 is available for ICD-11 mortality coding Date: 04. November 2025 Topics: Kodiersysteme Type: News

The Iris software has been used for ICD-10 mortality coding for more than 20 years. Now, Iris is also available for ICD-11 mortality coding.

Iris User Manual V6.1.0.9S1 - track changes PDF, 5,42 MB, File does not meet accessibility standards Date: 31. October 2025 Topics: Kodiersysteme Type: Download

Iris User Manual V6.1.0.9S1 - track changes

Iris User Manual V6.1.0.9S1 PDF, 4,41 MB, File does not meet accessibility standards Date: 31. October 2025 Topics: Kodiersysteme Type: Download

Iris User Manual V6.1.0.9S1

User Interface English V6.1.0-Y2025S1 ZIP, 14 kB, File does not meet accessibility standards Date: 31. October 2025 Topics: Kodiersysteme Type: Download

User Interface English V6.1.0-Y2025S1

Downloads Iris Institute - Terms and conditions for downloading (PDF, 244 kB) PDF, 244KB, File is accessible Date: 17. October 2025 Topics: Kodiersysteme Type: Download

Downloads Iris Institute - Terms and conditions for downloading

Comments concerning texts published in Issue 12.2 PDF, 329KB, File does not meet accessibility standards Date: 01. October 2025 Topics: Licensing Type: Download

Comments concerning texts published in Issue 12.2

Causes of death coding in Iris with ICD-11 testing results PDF, 207KB, File is accessible Date: 22. September 2025 Type: Download

Causes of death coding in Iris with ICD-11 testing results

Non-exhaustive list of multidrug-resistant bacteria and criteria for classification of an antibiotic as a reserve antibiotic according to § 35a para. 1 SGB V (as of 4 August 2025) PDF, 316KB, File does not meet accessibility standards Date: 04. August 2025 Type: Download

Reserve antibiotics: Exemption from the benefit assessment by standardized criteria according to §35A social code book (SGB) V

Guidance for Applicants Scientific Advice PDF, 311KB, File is accessible Date: 15. July 2025 Topics: About BfArM Type: Download

Guidance for Applicants Scientific Advice

Radiation applications in combined clinical trials (clinical trials submitted to both CTIS and DMIDS) Date: 14. July 2025 Type: News

For studies with submission in CTIS and DMIDS, only one radiation protection submission is required - depending on the study focus CTIS or DMIDS.

Presenation Iris Webinar July 2025 PDF, 411KB, File does not meet accessibility standards Date: 09. July 2025 Topics: Kodiersysteme Type: Download

Presenation Iris Webinar July 2025

New version of the DMIDS module "Clinical investigations and performance studies" from July 1, 2025 Date: 24. June 2025 Topics: Medical devices Type: News

The BfArM launches a new version of the DMIDS module "Clinical investigations and performance studies" on July 1, 2025.