The IVDR (EU 2017/746) Annex I General Requirements extension contains:
- RVT file for an EU IVDR Requirement and a corresponding DOCX Reporting style templates
- Over 129 importable Requirements derived from Annex I in IVDR (EU 2017/746)
This gives IVD medical device manufacturers a predefined starting point when setting up their technical file with the intention of accelerating the documentation effort.
Unzip the downloaded file. Place the rvt and docx file in your template folders. Import the xml file containing the Requirements into Aligned Elements. When importing this extension, make sure that the "Recreate chapters" option is selected in the import dialog.
