CE Marking Compliance Services for European Market Access

A Notified Body is an organization designated by an EU country or through a mutual recognition agreement that certifies whether products meet European Union regulations and industry standards. EU countries notify conformity assessment bodies within their jurisdictions, which are insured and cover their own professional activities unless the national legislation of the notifying country assures liability. Find the official list of EU-recognized UL Solutions Notified Bodies here.

Notified Bodies streamline the certification process and enable manufacturers to sell their products in EU markets with confidence. They perform conformity assessment services to help demonstrate that your products meet technical requirements and quality standards necessary to place your products on the EU market.

Manufacturers may choose any legally designated Notified Body to conduct their conformity assessment services. According to Decision 768/2008/EC, NBs can:

• Carryout conformity assessments based in EU or non-EU territories.
• Provide non-discriminatory, transparent, neutral, independent and impartial services.
• Ensure that services are performed by qualified personnel according to applicable laws and standards.
• Preserve the confidentiality of the information collected.
• Provide information to your notifying authority, the market surveillance authorities and other NBs.

Market surveillance helps ensure that products sold in the European Union conform to applicable laws and regulations, including the latest health and safety requirements. By fostering a level playing field for economic operators, market surveillance also helps maintain consumer confidence in European products. EU-wide cooperation occurs through informal groups called Administrative Cooperation groups (AdCos), including AdCo RED, which represents electromagnetic compatibility,and the Radio Equipment Directive (RED). Member states appoint AdCos to represent the national authorities responsible for a particular sector. They’re able to:

• Cover a full range of actions, including oversight of the market, and enforce corrective measures and penalties when necessary. This involves close contact with manufacturers, importers, distributors, online platforms, retail shops, consumers and consumer organizations.
• Work with brick-and-mortar shops and online markets to collect or assemble samples and send them to specialized laboratories for analysis to monitor product safety and issue alerts.
• Cooperate closely with customs to prevent unsafe or non-compliant products from entering the EU market.

Each country’s market surveillance authority is able to initiate actions outside the coordinated surveillance initiatives conducted by the Administrative Cooperation group. However, local authorities are still responsible for conducting investigations in the product sectors in which they occur. AdCo members meet several times per year at the EU level to share information and coordinate action plans for each sector. The European Commission then releases the results of these initiatives to all EU member states, authorities and citizens.

See the list of national market surveillance authorities by country or by sector.

Over the last ten years, many AdCo-coordinated action initiatives have addressed electromagnetic compatibility (EMC) and radio products. The European Commission has published these results and removed non-compliant EMC and radio products from circulation. A product can be barred from entering the market for even a minor nonconformity, costing manufacturers and importers money and time as well as damaging consumer opinion and brand value. Learn more about market surveillance activity and find the 2022 AdCo RED Report on the 10th RED Market Surveillance Campaign on IoT.

• Manufacturers must meet the latest safety and EMC and radio compliance obligations and apply all applicable European Norm (EN) standards published in the latest edition of the Official Journal of the European Union (OJEU) before their products can circulate in the EU market.
• Some EN standards are not available or harmonized, are in draft form or only partially cover a product. When standards are not listed in the RED OJEU, manufacturers are required to work with a Notified Body.
• A Notified Body can help demonstrate product compliance even where harmonized standards are available.
• Market surveillance exercises show that even if an EN standard fully covers a product, nonconformities may still be present that require corrective measures or are subject to complete market removal because of significant deviations from expected EN standards. Products that have undergone testing and achieved approval may sometimes still not comply with field tests or display unexpected behavior.

2022 noncompliance rates from RED AdCo

• 62.12% of products exhibited some form of noncompliance.

You’re probably already aware that withdrawing products from the market can result in substantial financial losses, but did you know that NBs can provide you with a group of experts with in-depth knowledge of your products?

Engaging a Notified Body to check your technical files before a market surveillance exercise can help identify and reduce the number of noncompliance issues, allowing you to avoid considerable costs and delays in bringing your product to market. A Notified Body is also required to review your technical file and issue a type evaluation certificate (TEC) before your product is allowed to access the global market. Manufacturers often engage Notified Bodies:

• When not using harmonized standards listed in the OJEU.
• To ensure a technical file correctly reflects the latest thinking regarding standards and Technical Guidance Notes (TGN).
• To acquire the TEC for global market access.