Product and organisation details
Identify the responsible organisation, manufacturer and authorised contact. Give the product name, model or formulation, relevant software release and supply markets. Describe the intended users and the task and setting for which recognition is sought.
Evidence for the claims
Create an index connecting each principal claim with its supporting file and relevant page. Include the method, findings, applicability and limitations. The claims and evidence worksheet provides the fields to organise this material.
Instructions and the user experience
Include current labels, warnings and instructions. Explain setup, operation, understanding results, errors and ongoing maintenance. Show what evidence addresses these tasks and any assistance required. Use the use-context worksheet to describe the people, task and environment consistently.
Files and access
| File requirement | Limit |
|---|---|
| 25 MB per file | |
| JPEG, PNG or AVIF image | 10 MB per file |
| Total attachments | 20 files and 250 MB per entry |
Open every file before uploading. Remove unnecessary personal information and check your right to share it. If a demonstration is relevant, provide a stable HTTPS link, the version shown and any expiry or access instructions.
Before you submit
- Match the product identifiers across the application, evidence and instructions.
- Explain differences between the product entered and the product studied.
- Include limitations and important contrary findings.
- Check the proposed public summary and image rights.
- Complete the declarations and review the submission screen.
The entry checklist is a concise copy to use alongside your files. Submitting fixes the application; later material is supplied through a request from the team.