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Process step 1 - Entering your key product information

This first process step involves entering the product and stakeholder information required in a CE evaluation. CERTAIN breaks this step into 4 sections which will explained individually in this guide.

1. The Product overview - your dashboard

All your projects / products are listed here.

2. Select the Project

Click on the product or project you wish to open.

3. Click on the Key Data bullet

This will allow you to begin entering your company, project and product details.

4. Key Data entry

Here are four sections to be filled with information, each in turn.

  • Product manufacturer
  • Documentation authorised representative
  • Project team
  • Product information

Section 1 - Manufacturer Information

5. Manufacturer details

This is either your own company (if you are assessing your own product) or a third party manufacturing company (if you are carrying out the conformity assessment as an external CE service provider for a manufacturer)

This name will appear on the final product documentation, so make sure you include the official company name and designation.

If you wish to save this manufacturer for future reference in your manufacturer list, click on the highlighted field. It will be added to your manufacturer list for future reference.

The Managing Director entry is also of great importance as that defines the authorised signatory at the end of the CE process.

6. Complete the manufacturer details

Enter the manufacturer's main contact address and main telephone number

Optional fields are labelled as such and may be left blank.

Click and upload the manufacturer logo here. (max 5MB)

This logo will appear in your final documentation.

8. Logo successfully uploaded

This logo may be updated or deleted any any stage.

To continue click on next step.

Section 2 - Authorised documentation representative

💡 The role of the authorised documentation representative?

The authorised documentation representative is a crucial role appointed by the manufacturer, either a natural person or a legal entity established within the European Union (EU). This role is specific to manufacturers of products falling under EU directives requiring CE marking.

The main responsibilities of the authorised documentation representative include:

  1. Documentation Storage: The authorized representative is responsible for retaining the Declaration of Conformity (Doc) and technical documentation prepared by the manufacturer. These documents must be available for at least 10 years after the last product has been placed on the market.
  1. Cooperation with Authorities: If national authorities or the European Commission have inquiries regarding the product's conformity, the authorized representative acts as the contact person and collaborates with these authorities.
  2. Responding to Inquiries: The authorized representative must be capable of responding to inquiries from national authorities within reasonable timeframes and providing all necessary information.
  3. Ensuring Traceability: The authorized representative ensures that products are traceable through appropriate labeling.

The authorized documentation representative does not have the same legal status as the manufacturer. They do not assume responsibility for the product's conformity; instead, they are responsible for the proper storage and provision of necessary documentation. The primary responsibility for the product's conformity remains with the manufacturer.

9. The authorised documentation representative

This authorised representative is the person who has been commissioned by the manufacturer to compile the technical documentation.

10. Enter contact details.

Enter the contact details of the authorised documentation representative.

11. When finished, click on next step

Section 3 - Project Team Members

12. Enter the project team members

Enter the names and contact details of the key project team members.

Click on 'add another' to include further team members.

It is especially important to include those functional members of the product development team contributing to the risk assessment and responsible for hazard mitigating measures. This list of project members is included in the final risk assessment document.

When the list is complete click on next step.

Team members can be added, deleted or edited at any time.

Section 4 - Product Information

13. Enter the key product information

The product name will be assumed from the project title you provided. If changed here, the project name will also be amended.

Enter all the known product details. Mandatory fields are indicated.

The information you enter here is important it will appear in this form in the final product documentation and declaration of conformity.

14. Date of placing on the market

Enter the expected / actual date on which the product will be placed on the market.

15. Enter the product description

Carefully and concisely describe the product and the general function it is intended to fulfil. This description will appear in the declaration of conformity and in the documentation.

16. Upload a product illustration

A picture or illustration of the product must be provided and described in the operating instructions. It will be displayed here in the application. (max 5MB)

Save your project and product information

17. Click on Save Product Data

This will save the infomation added in the last four steps. Not doing so may require the re-entry of all the previous information.

(v0.0.3)