Map MDR requirements to your technical-file evidence.

Choose the workbook or a plain-file alternative

What is inside the Excel workbook

The preparation rows cover device description, labeling, design and manufacturing, GSPR mapping, risk management, verification, clinical documentation and post-market surveillance. They include device-dependent topics such as software, biological safety, sterility and measuring functions. Review applicability instead of assuming every row applies.

Turn the register into an index to your evidence

1. Define the device, intended purpose, variants, software versions and assessment context on the Start here sheet.
2. Review the preparation topics with the responsible specialists. Record applicability and a device-specific rationale for exclusions.
3. Enter controlled document IDs, exact revisions and section or page locations. Add a working row for another evidence document and give it a unique row ID.
4. Track evidence presence separately from review status. Assign unresolved questions to an owner with a specific next action.
5. Enter reviewer details and the actual date only after review. Maintain references when controlled documents change.

Conformo Editorial Team prepared these original organizational templates using the references below. They have no claimed independent regulatory approval. Your device, classification and assessment route may require additional documentation and qualified review; filling the register does not establish conformity.

An evidence reference that can be checked

This entry identifies where the reviewer should look and what remains unresolved. It deliberately does not claim that the evidence is adequate or the device conforms.