Tuttlingen – Understanding comes before application. This is especially true if documents that are important for the medical technology industry have so far only been available in English. MedicalMountains GmbH is therefore continuing a joint project to support manufacturers in the application: You can obtain the translation of the IMDRF codes in the current version 5.0 at the MedicalMountains joint price.
The International Medical Device Regulators Forum (IMDRF) document provides medical device adverse event terms and numeric codes. The [Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (AIMDD/MDD/IVDD)] form and related documentation uses IMDRF terms and codes in English. The translation does not represent an official or authorized language version. However, it helps to better understand, interpret and assign the individual points.
The translation includes:
• Annex A: Medical Device Problem (Excel spreadsheet)
• Annex B: Cause Investigation – Type of Investigation (Excel spreadsheet)
• Annex C: Cause Investigation – Investigation Findings (Excel spreadsheet)
• Annex D: Cause Investigation – Investigation Conclusion (Excel spreadsheet)
• Annex E: Health Effects – Clinical Signs and Symptoms or Conditions (Excel spreadsheet)
• Annex F: Health Effects – Health Impact (Excel spreadsheet)
• Annex G: Medical Device Component (Excel spreadsheet)
in edition 5.0.
MedicalMountains GmbH is working together with Transline Deutschland GmbH on this project. Since the existing translations can be built on, the costs for the new version are even lower:
The translated IMDRF codes can be obtained for EUR 600 plus VAT as soon as at least five partners come together.
More information about the joint project
Meinrad Kemp
Email kempf@medicalmountains.de
Telephone +49 7461 9697218
