Discuss this signal with compliance peers, get the weekly digest, and never miss an enforcement deadline that affects your products.
EU conformity assessment procedures are mandatory verification processes that manufacturers must complete before placing products on the European market. The European Commission's Blue Guide establishes that only notified bodies can issue valid certificates for harmonised products, while warning that voluntary certificates from non-notified bodies have no legal value for compliance verification.
The European Commission's primary objective is to prevent unsafe or non-compliant products from entering the EU market. Conformity assessment serves as the gatekeeper mechanism, requiring manufacturers to demonstrate compliance with all applicable legislative requirements before market placement. This system operates alongside market surveillance to ensure the smooth functioning of the internal market.
The conformity assessment framework applies across all New Approach Directives and Regulations, covering sectors from machinery and electromagnetic compatibility to radio equipment and personal protective equipment. Each product legislation specifies the exact conformity assessment procedure required for that product category.
The European Commission has issued explicit warnings about misleading voluntary certificates that create false impressions of compliance. According to official guidance, "voluntary certificates can create the impression that the product conforms with applicable EU harmonisation legislation, although such certificates are not issued by an authorised body."
The Commission emphasises that under EU law, voluntary or additional certificates are not recognised means to prove compliance and "have no value in case of checks by market surveillance authorities or customs." This represents a significant clarification for manufacturers who may have relied on non-notified body certificates.
The Blue Guide on EU Product Rules, published in the Official Journal of the European Union (C 247, 27.4.2022), provides the authoritative framework for conformity assessment procedures. The guidance establishes that conformity assessment must demonstrate that products being placed on the market comply with all legislative requirements.
Product legislation describes specific conformity assessment procedures for each product category. Where applicable legislation provides options, manufacturers may choose between different conformity assessment procedures. However, the manufacturer remains responsible for carrying out the assessment, with conformity assessment bodies involved only when required by applicable legislation.
The framework requires that conformity assessment include testing, inspection and certification as specified by the applicable product legislation. Each procedure must ensure confidence among consumers, public authorities and manufacturers regarding product conformity.
The clarification on voluntary certificates affects manufacturers across all harmonised product sectors. Companies that have obtained certificates from bodies not notified for their specific product category face compliance gaps that market surveillance authorities will not recognise.
Manufacturers in machinery, electromagnetic compatibility, radio equipment, and personal protective equipment sectors are particularly affected, as these areas have seen proliferation of voluntary certification schemes. The Commission specifically notes that "if a body is notified for issuing certificates for machinery, it should not issue certificates (voluntary or other) for non-machinery products (such as personal protective equipment – masks)."
Customs authorities and market surveillance bodies will not accept voluntary certificates as proof of compliance during product checks. This creates enforcement risk for companies relying on such documentation.
Manufacturers must complete conformity assessment procedures before placing products on the EU market. The process requires demonstration that products meet all applicable legislative requirements through the specific procedure outlined in relevant product legislation.
As part of conformity assessment, manufacturers or their authorised representatives must draw up a declaration of conformity. The declaration must contain information to identify the product, the legislation according to which it is issued, the manufacturer or authorised representative, the notified body if applicable, and reference to harmonised standards or other normative documents where appropriate.
CE marking can only be affixed after testing the product and performing the conformity assessment procedure prescribed by applicable EU harmonisation legislation. The Commission explicitly states that "it is not acceptable for certificates to bear a CE marking."
Only notified bodies may issue certificates of compliance for harmonised products, and only within their designated notification scope. Manufacturers must verify that any third-party certification comes from properly notified bodies operating within their authorised competence area.
The Blue Guide requirements are immediately applicable across all EU member states. Market surveillance authorities and customs officials are instructed to reject voluntary certificates during compliance checks.
Enforcement focuses on distinguishing between valid notified body certificates and misleading voluntary certificates. Authorities will verify that certification bodies operated within their notified scope when issuing compliance certificates.
The Commission warns that voluntary certificates must not be confused with legitimate third-party conformity assessment certification by notified bodies, despite use of terms such as 'certification' or 'independent third party.'
The conformity assessment requirements apply uniformly across all EU member states. However, market surveillance enforcement may vary between national authorities in terms of inspection frequency and penalty structures.
Some member states have implemented additional guidance on identifying misleading voluntary certificates, while others rely on the Commission's Blue Guide framework. Manufacturers should monitor national market surveillance authority communications for specific enforcement approaches.
Verify that all product certificates come from notified bodies operating within their designated scope. Check the NANDO database to confirm notified body status and competence areas before accepting any certification.
Review existing voluntary certificates to identify compliance gaps. If products rely on certificates from non-notified bodies, initiate proper conformity assessment procedures immediately. Prioritise products with highest market exposure and enforcement risk.
Update declaration of conformity documents to ensure they contain all required identification information. Remove references to voluntary certificates that have no legal recognition under EU law.
Train procurement and compliance teams to distinguish between valid notified body certificates and misleading voluntary certificates. Establish verification procedures to check notified body status before accepting supplier certifications.
Monitor market surveillance authority enforcement bulletins for guidance on certificate verification requirements. Some authorities may publish specific criteria for identifying non-compliant certification practices.
Develop supplier qualification procedures that require valid notified body certificates for all harmonised products. Include contractual requirements for suppliers to provide only legally recognised compliance documentation.