Who are the stakeholders in the conformity assessment procedure and what are their responsibilities?

Stakeholders in the conformity assessment procedure of a product can be the following parties: sectoral legislator, manufacturer, conformity assessment body, national accreditation organisations, and notifying authorities of the Member States.

Each one of the mentioned stakeholders has different responsibilities in the CE compliance process. For instance, the responsibilities of the sectoral legislator are:

• To set out the legal requirements that products have to fulfil to become CE compliant
• And to select the appropriate conformity assessment modules.

On the other hand, the manufacturer is responsible for:

• The design, manufacturing and testing of the product
• Drafting the product's technical documentation, the format of which must be based on EN ISO standards
• Taking all the adequate measures necessary to ensure that the product complies with the EU regulations
• In some cases, he must perform conformity assessment of the product.
• Upon a positive assessment result, he needs to produce the declaration of conformity and affix the CE marking on the product.
• Upon the intervention of a notified body, the manufacturer is obliged to attach the notified body's identification number to the product
• The declaration of conformity of the product, along with its technical file, must be kept for ten years and provided to the national authorities immediately upon request.

Moreover, as mentioned earlier, responsibilities are given to the conformity assessment body as well, which include:

• To perform the conformity assessment on products if the European legislation states so
• And, upon a positive evaluation, the conformity assessment body must issue an approval.

Furthermore, when it comes to the national accreditation organisations (one per each EU Member State), they must:

• Evaluate and survey the competence of the conformity assessment bodies
• And, upon a positive evaluation, to issue an accreditation certificate for the assessment body in question.

Lastly, considered as well as stakeholders in the conformity assessment procedure, the Notifying authorities of the Member States are responsible for notifying the external conformity assessment bodies, which are within their jurisdiction, to demonstrate technical competence for assessing the compliance of products with the CE directives relevant to them.