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notes on completing the summary evaluation of serious adverse events PDF, 73KB, File is accessible Date: 11. November 2021 Topics: Medical devices Type: Form

Template notes version 4, 2021-06-25

Evaluation docx, 24KB, File does not meet accessibility standards Date: 11. November 2021 Topics: Medical devices Type: Form

SAE / DD summary evaluation
Template version 4, 2021-06-25

Update of Iris version and decision tables available Date: 14. May 2021 Topics: Kodiersysteme Type: News

We published a new version of the Iris software and the associated MUSE files - V5.8.1-Y2021S2 and specV2021SR30-Muse. It includes the updates of unicausal and multicausal tables for 2021.

New Iris version and decision tables available Date: 03. February 2021 Topics: Kodiersysteme Type: News

We published a new version of the Iris software and the associated MUSE files - V5.8.0-Y2021S1 and specV2021SR10-Muse. It includes the unicausal and multicausal tables for 2021. Previous version 5 releases have been tested thoroughly and detected …

Update - decision tables for emergency codes U07.1 and U07.2 Date: 25. March 2020 Topics: Kodiersysteme Type: News

The World Health Organisation (WHO) activated the ICD-10 emergency codes U07.1 and U07.2, and assigned them to "COVID-19" cases after consultation with the responsible committee of the WHO Family of International Classification (WHO-FIC) Network.

Update - decision tables Date: 16. March 2020 Topics: Kodiersysteme Type: News

On 30.1.2020, the WHO determined that the current outbreak of the novel coronavirus is a "public health emergency of international concern" (PHEIC). After consultation with the responsible committee of the WHO Family of International Classification (

MIR-XSDs zip, 29KB, File does not meet accessibility standards Date: 15. October 2019 Topics: Medical devices Type: Form

MIR-XSDs

MIR-XSDs zip, 29KB, File does not meet accessibility standards Date: 15. October 2019 Topics: Medical devices Type: Form

MIR-XSDs

XSDs for direct reporting from manufacturer databases into XML zip, 28KB, File does not meet accessibility standards Date: 28. August 2018 Topics: Medical devices Type: Form

SAE: XSDs for manufacturers, who wish to report directly from their database into an XML file that fulfils the requirements for electronic reporting.

Notification of the Stufenplanbeauftragter rtf, 265KB, File does not meet accessibility standards Date: 06. June 2018 Topics: Pharmakovigilanz Type: Form

According to § 63a subparagraph 3 of the German Medicines Act (AMG), pharmaceutical entrepreneurs are obligated to notify a Stufenplanbeauftragter to the competent authority, the responsible regional authority and, if necessary, also to the …