# Prepare your CE marking file

A Cleo working template to complete for your product. The documents and procedure depend on the applicable legislation. Completing this checklist is not a completed assessment or a declaration of conformity.

## Identify the product and your role

- Product, model, reference and version:
- Intended use and users:
- Manufacturer, address and contact:
- Your role: manufacturer, importer, distributor or authorised representative:
- Destination markets:

## Link each requirement to evidence

| Applicable legislation and requirement | Method or standard used | Evidence document and version | Status | Owner |
| --- | --- | --- | --- | --- |
| To complete | To complete | To complete | To complete | To complete |

## Gather the relevant documents

- [ ] Product description, drawings and bill of materials.
- [ ] Regulatory scope and applicable conformity assessment procedure.
- [ ] Risk assessment and measures taken.
- [ ] Standards used, with justification of alternative methods where relevant.
- [ ] Test reports and supplier documents matching the product model.
- [ ] Notified body involvement and documents, where the procedure requires them.
- [ ] Label, markings, instructions and required languages.
- [ ] Draft EU declaration of conformity and authorised signatory.
- [ ] File location, responsible person, and updating and retention rules.

## Record what is missing

| Missing document or evidence | Next action | Contact | Due date |
| --- | --- | --- | --- |
| To complete | To complete | To complete | To complete |

## Official sources and support

- [CE marking: scope, process and notified bodies](https://europa.eu/youreurope/business/product-rules-compliance/general-product-compliance/ce-marking/index_en.htm)
- [Technical documentation: content and evidence](https://europa.eu/youreurope/business/product-rules-compliance/general-product-compliance/preparing-technical-documentation/index_en.htm)
- [Conformity assessment: selecting a procedure](https://europa.eu/youreurope/business/product-rules-compliance/general-product-compliance/conformity-assessment/index_en.htm)
- [Cleo: CE marking file preparation](https://www.cleolabs.co/en/compliance-as-a-service/ce-marking)