BfArM - Federal Institute for Drugs and Medical Devices

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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.

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.

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.

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.

New radiation protection regulations effective July 1, 2025 Date: 20. June 2025 Type: News

Effective July 1, 2025, new regulations will apply to radiation protection approvals or notifications for clinical trials.

Approval procedure pursuant to Section 31 of the German Radiation Protection Act (Strahlenschutzgesetz, StrlSchG) of 1 July 2025 Date: 20. June 2025 Type: News

The article provides information on the correct procedure for approval procedures in accordance with Section 31 StrlSchG (Strahlenschutzgesetz (German Radiation Protection Act)) in the context of CTR applications and Substantial Modification in CTIS.

Notification procedure pursuant to Section 32 of the German Radiation Protection Act (Strahlenschutzgesetz, StrlSchG) of 1 July 2025 Date: 20. June 2025 Type: News

This article provides information on the correct procedure for reporting a notification procedure in accordance with Section 32 StrlSchG (Strahlenschutzgesetz (German Radiation Protection Act)) as part of CTR submission and for Substantial …

Save the date – next Iris webinar Date: 05. June 2025 Topics: Kodiersysteme Type: News

The next Iris webinar will be held on 9th July 2025.

German SAE Report Form PDF, 1MB, File does not meet accessibility standards Date: 28. May 2025 Topics: Medical devices Type: Form

Report form for reporting of serious adverse events (SAE) in clinical trials or performance studies for use by sponsors according to § 3 (5) of the Ordinance on Medical Devices Vigilance

PDF-Form (use of Adobe Acrobat 9.X recommended)

Iris user survey Date: 17. April 2025 Topics: Kodiersysteme Type: News

The Iris user survey is now available!

Save the date – next Iris webinar Date: 31. March 2025 Topics: Kodiersysteme Type: News

The next Iris webinar will be held on 15th April 2025.

Reminder: Iris user group meeting – register now Date: 26. March 2025 Topics: Kodiersysteme Type: News

The Iris user group meeting will take place on 15th and 16th May 2025 in Cologne.

Iris training: Save the date and register Date: 12. February 2025 Topics: Kodiersysteme Type: News

The Iris training will be held as a web-based training from 31st March until 3rd April 2025.

Save the date – next Iris webinar Date: 24. January 2025 Topics: Kodiersysteme Type: News

The next Iris webinar will be held on 19th February 2025.

Iris user group meeting – save the date and register Date: 22. January 2025 Topics: Kodiersysteme Type: News

The dates and information for the next Iris user group meeting are available.

New version of Iris version 6 is available for testing with ICD-11 Date: 16. December 2024 Topics: Kodiersysteme Type: News

The second test version of Iris version 6 for ICD-11 mortality coding has been released. You will find version 6.0.26 and the Iris Manual under “Downloads” on our website.

Save the date – next Iris webinar Date: 26. November 2024 Topics: Kodiersysteme Type: News

The next Iris webinar will be held on 11th December 2024.

Update of decision tables for Iris version 5 available Date: 28. October 2024 Topics: Kodiersysteme Type: News

We published updates of the decision tables (specV2021SR50Muse). The new decision tables are available in the Iris download area.

Save the date – next Iris webinar Date: 10. October 2024 Topics: Kodiersysteme Type: News

The next Iris webinar will be held on 13th November 2024.

Update of Iris version 5 Date: 09. September 2024 Topics: Kodiersysteme Type: News

We published a new version of the Iris software – V5.8.4-Y2024S2.