Deficiencies in documents issued by notified bodies to demonstrate product conformity

Companies must always verify the conformity of products with requirements before placing them on the market. Detailed requirements for the conformity assessment procedure and for the documents demonstrating conformity with the requirements are presented in product-specific legislations.

Legislations determine whether a third party, i.e. a notified body, is required for the conformity assessment. In this case, the documents that demonstrate a product’s conformity with requirements usually consist of a type-examination certificate (Module B), technical documents and the EU Declaration of Conformity (DoC) or the Declaration of Performance (DoP). In certain product groups, evidence of quality control conducted by a notified body during production is also required (quality control modules or class AVCP procedures).

The EU Declaration of Conformity and/or the Declaration of Performance must be prepared and signed by the product’s manufacturer or authorised representative. 

Certificates issued by a notified body must be issued to the manufacturer. All documents that demonstrate conformity with requirements must be traceable to the product and each other. 

A product’s importer or distributor is the product’s manufacturer when it places the product on the market under its own name or trademark, or changes a product previously placed on the market in such a way that compliance with the requirements may be affected. In these situations, the obligations set for manufacturers apply to the importer or distributor. For example, the EU Declaration of Conformity and the Declaration of Performance must, in this case, be prepared by the new manufacturer, and the notified body’s certificates must be issued to it.  

Documents that demonstrate conformity with requirements play a key role not only in product safety, but also in ensuring free movement and a well-functioning European single market. 

Grounds for withdrawing a product from the market

The Finnish Safety and Chemicals Agency (Tukes) mandates a product to be withdrawn from the market if there are such deficiencies in the documents issued by a notified body to demonstrate conformity with requirements that the product’s conformity with requirements cannot be verified based on the documents.

Examples of deficiencies in documents issued by notified bodies:

• No type-examination certificate or evidence of quality control during production by a notified body.
• The type-examination certificate has been issued to a company other than the manufacturer indicated on the product.
• The type-examination certificate has been issued to a trademark other than the trademark used in product marketing.
• The product indicated in the type-examination certificate is not identical to the product indicated in the quality control certificate.

For products within the scope of application of the Construction Products Regulation, documents issued by a notified body include:

• Certificate on constancy of performance (AVCP 1 and 1+)
• Certificate on the conformity of internal production quality control with requirements (AVCP 2+)
• Determination of product type by a notified testing laboratory in accordance with the harmonised product standard (AVCP 3)

Products intended for the transport of dangerous goods

For products intended for the transport of dangerous goods, documents issued by a notified body include the type approval certificate, conformity approval certificate for manufacturing, type reassessment certificate, and inspection certificates related to scheduled, interim and additional inspections.

The above guidelines also apply to these documents.