Notified body

# Notified body A notified body is an independent conformity assessment organisation designated by an EU member state to carry out third-party assessment tasks under EU harmonisation legislation. Notified bodies perform EU type examinations, approve quality systems and verify products, and their involvement is mandatory for higher-risk products before CE marking can be affixed. ## Key facts - Notified bodies are designated by national notifying authorities and notified to the European Commission, which lists them in the public NANDO database. - Each notified body receives a four-digit identification number that follows the CE marking when the body was involved in the production control phase of conformity assessment. - They operate under specific EU directives and regulations, with a defined scope of products and conformity assessment modules. - Designation requires demonstrated competence, impartiality and independence, typically evidenced by accreditation to ISO/IEC 17025 or ISO/IEC 17065. - Well-known examples include organisations such as TUV, BSI, DEKRA, SGS and Bureau Veritas, each notified for many legislative scopes. - In Great Britain, the equivalent organisations are called approved bodies and are listed by the UK government for UKCA marking. - Choosing the wrong body, or one without the right scope, invalidates the certification and the CE marking. ## What notified bodies do EU product legislation defines conformity assessment modules, labelled A through H, that describe who assesses conformity and how. For low-risk products, Module A allows the manufacturer to assess conformity internally without any third-party involvement. As product risk rises, the legislation requires a notified body to examine the product type, audit the manufacturer's quality system or verify production. Typical tasks include EU type examination (Module B), where the body examines the technical design and tests a specimen; conformity to type based on internal production control plus supervised product checks (Module C2); quality assurance of the production process (Module D) or of the product (Module E); and full quality assurance covering design and production (Module H). For medical devices, machinery, pressure equipment, radio equipment and many other categories, the applicable module combination determines exactly when a notified body must be engaged. The notified body's output is a certificate or approval decision, such as an EU type-examination certificate, which the manufacturer keeps as part of the technical documentation. The manufacturer then draws up the EU Declaration of Conformity and affixes the CE marking, adding the notified body's four-digit number where the legislation requires it for the production phase. ## Designation, NANDO and scope A body becomes a notified body through a formal process. It applies to the notifying authority of its member state, demonstrating competence for the requested legislation and modules, usually through accreditation by the national accreditation body. The authority assesses the application, and if satisfied, notifies the body to the European Commission and the other member states. After a standstill period for objections, the Commission publishes the body in NANDO, the New Approach Notified and Designated Organisations database, with its identification number and precise scope. Scope is everything. A body notified for the Medical Devices Regulation cannot certify toys unless it is also notified for the Toy Safety Directive, and notification for Module B does not automatically cover Module D. Manufacturers must check NANDO for the legislation, the product categories and the modules before engaging a body, and should confirm that the scope will remain valid for the expected lifetime of the certificate. Screenshots or exports of the NANDO entry should be kept in the technical file as evidence of due diligence. Notified bodies are monitored after designation. Notifying authorities reassess them periodically, and the Commission and member states can challenge a notification if doubts arise about competence or impartiality. A body whose notification is withdrawn or restricted can leave manufacturers scrambling to transfer certificates, which is why the body's reputation and stability matter commercially. ## Impartiality and the limits of the role Notified bodies must be independent of the products they assess. They cannot be the designer, manufacturer, supplier or installer of the products they certify, and their remuneration must not depend on the number or outcome of assessments. This independence is audited during designation and reassessment, and it is what gives the CE marking system its credibility. Manufacturers sometimes misunderstand the relationship. The notified body assesses conformity against the legislation; it does not design the product, write the technical documentation or take responsibility for compliance. The legal responsibility for the product remains with the manufacturer, who signs the declaration of conformity. Treating the notified body as a consultant that will fix compliance gaps leads to failed assessments and delays. Confidentiality is protected: bodies must safeguard proprietary information obtained during assessment. At the same time, they must inform notifying authorities and cooperate with market surveillance when they find serious non-compliance, and they must share information about negative assessment results with other notified bodies to prevent certificate shopping after a refusal. | Module | Notified body involvement | Typical products | |---|---|---| | A | None, internal production control | Low-risk electrical goods, toys | | B + C | EU type examination, then internal control | Machinery, radio equipment | | B + D | Type examination plus production quality assurance | Medical devices, pressure equipment | | G | Unit verification of each product | One-off pressure vessels, lifts | | H | Full quality assurance of design and production | High-risk medical devices | | H1 | Full QA plus design examination | Highest-risk categories | ## Working with a notified body: practical steps Engagement typically starts with an application describing the product, the applicable legislation and the desired modules. The body reviews the technical documentation, agrees a test and assessment plan, and may witness testing or carry it out in its own or subcontracted laboratories. For quality system modules, auditors visit the manufacturing sites. Timelines range from weeks for straightforward type examinations to many months for complex medical devices. Costs are significant and should be budgeted from the product planning stage: application fees, documentation review, testing, audits, travel and annual surveillance all add up. Delays usually come from incomplete technical documentation, so preparing the file to the body's guidance before applying saves both time and money. Many bodies publish application guides and pre-assessment checklists. Certificate maintenance is ongoing. Design changes must be notified to the body, which decides whether re-examination is needed. Quality system certificates require periodic surveillance audits, and certificates have expiry dates, typically up to five years depending on the legislation. Letting a certificate lapse while products are still being placed on the market breaks the conformity chain. ## Approved bodies and the UK After Brexit, the United Kingdom created a parallel system of approved bodies for UKCA marking, designated by the UK government under the relevant UK statutory instruments. Many are the UK-established entities of the same groups that operate as notified bodies in the EU. A body cannot be both a notified body and an approved body in the same legal entity for the same purpose; the roles attach to the jurisdiction. For products sold in both Great Britain and the EU, manufacturers may need both an approved body assessment for UKCA and a notified body assessment for CE, unless the applicable rules allow self-declaration. Northern Ireland follows special arrangements under which CE marking and notified bodies continue to apply for goods placed on the Northern Ireland market. Checking the current UK guidance for each product category is essential, because recognition arrangements have evolved since 2021. ## Frequently asked questions How do I find a notified body for my product? Search the Commission's NANDO database by legislation, filtering for the product category and the conformity assessment modules you need. Verify the body's scope covers your exact product type before applying. Does using a notified body transfer legal responsibility? No. The manufacturer remains legally responsible for the product's conformity and signs the EU Declaration of Conformity. The notified body's certificate is evidence supporting that declaration, not a substitute for it. What does the four-digit number after the CE marking mean? It identifies the notified body involved in the production control phase, where the legislation requires it. It allows market surveillance authorities to trace which body assessed the product. Can a notified body refuse to certify? Yes, and it must refuse where the product does not meet the requirements. Refusals are shared with other notified bodies, so addressing the underlying non-compliance is the only productive response. How long does notified body assessment take? It varies widely: weeks for simple type examinations, several months for quality system approvals, and longer for high-risk medical devices with clinical evaluation. Early engagement and complete documentation shorten the process. What happens if my notified body loses its notification? Certificates it issued may become invalid for new production, depending on the legislation and transitional provisions. Manufacturers should monitor their body's status and have contingency plans, including the possibility of transferring certificates to another body. ## Sources - EU notified bodies overview - NANDO database of notified bodies - New Legislative Framework building blocks