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 An overview of frequent mistakes in product compliance to CE Marking found during market monitoring by AdCos.

Market Surveillance Highlights Common Failures in CE Marking

The CE Mark ensures that products subject to EU harmonized legislation can circulate freely within the European Single Market. Achieving CE compliance to gain the coveted CE Mark can be a complex process due to the requirements of individual directives and regulations, especially when applied simultaneously. 

There has been criticism, however, that a small number of EU member states have not been rigorous enough in preventing non-compliant products from entering the market. Market surveillance is critical in not only ensuring a level playing field for manufacturers across all 28 Member States, but also in preventing unsafe products from entering the market and retaining a CE Mark, in which consumer confidence should be assured.

EU countries (Member States) must ensure active surveillance of their markets. These countries must guarantee that products placed on the market are monitored, the marking and documentation requirements are respected, and that products are designed and manufactured under EU harmonization requirements. Each country must also ensure that market surveillance authorities have the necessary powers, resources, and knowledge to perform their functions. Market surveillance programs must be established, implemented, and periodically updated with procedures in place for complaint follow-up and accident monitoring.

The role of AdCos in market surveillance

Cooperation between market surveillance authorities is a crucial element for the functioning of the Internal Market, taking place through informal groups of market surveillance authorities called Administrative Cooperation Groups (AdCos).  Appointed by Member States, the members of these groups represent national authorities responsible for market surveillance in a given sector, such as the Department for Transport for motor vehicles or OFCOM and the Department for BEIS for radio equipment under RED in the UK. 

Each AdCo meets several times per year to discuss market surveillance issues in their particular area of competence and ensure that surveillance is efficient, comprehensive, and consistent. Twice a year, the AdCos join to analyze each sector from a risk point of view and identify the most prominent concerns for the group.  Recently, the AdCos collectively identified a key issue of concern regarding CE Marking and non-compliance, finding that when products are randomly checked for compliance over half are failing, with an overall failure rate of 66%. Such a high number of CE Marking failures reported by AdCos suggest that the policing of CE marking directives by the European Commission will become even more stringent in addressing these concerns moving forward.

Administrative issues are the leading cause of non-compliance 

The majority of cases of non-compliance are related to administrative issues. Critical reasons for failure are due to issues regarding:

• CE Marking  
• Type, batch or serial number detailed on the product
• Name and address of the manufacturer
• Name and address of the importer
• Declaration of conformity 

One in four products non-compliant due to technical documentation

Technical documentation was the cause of 63% of non-compliance in 2018. The omission of a general description of the product in the technical documentation is a particularly common problem. The absence of a full list of the harmonized standards used is also a frequent reason for failure.

Example: CE Marking of radio products

With radio equipment as an example, it is apparent that non-compliance is not always related to administrative issues or technical documentation. One in three (36%) radio products failed due to technical issues, essential requirements of the directive. The majority of these are related to the radio parameters (Article 3.2). Perhaps one of the most significant concerns is the discovery that one in every ten radio products randomly tested is not considered compliant to the technical requirements for safety or EMC.

In conclusion, the majority of products failing to comply with CE Marking, radio or otherwise, are a result of administrative errors. This finding suggests a lack of knowledge of the requirements or directives that apply to the product in question.  These types of errors are relatively straight-forward to correct by ensuring that professional CE Marking advice is taken during a product’s testing and approvals journey. The discovered failures indicate that more guidance is also required for products through the critical stages of development ahead of the qualification process. To learn more about testing and approvals for CE Marking your device, please contact Element’s Engaged Experts. As a Notified Body for the key EU product safety and communications directives, including radio (RED), Element’s Advisory Services provide a continuous resource for compliance issues and expert help and guidance during final testing and certification.