Regulatory
Organisation designated by an EU member state to assess conformity of regulated products before EU market placement.
The Commission’s definition is the one that governs: “A notified body is an organisation designated by an EU country to assess the conformity of certain products before being placed on the market.” Designation is the member state’s act, made on principles laid down in Decision 768/2008/EC, and the Commission publishes the resulting lists on NANDO with each body’s identification number and the tasks it has been notified for. A notified body must be non-discriminatory, transparent, neutral, independent and impartial, adequately insured, and competent — verified at regular intervals following accreditation practice. It may serve any economic operator inside or outside the EU, and a manufacturer is free to choose any body legally designated for the procedure. What the term does not cover is Great Britain: UK guidance is explicit that Notified Bodies “can only be used to certify against EU requirements”, and the British equivalents are UK Approved Bodies accredited by UKAS and listed on UKMCAB. Using the wrong one is a common and expensive mistake.
Conformity marking is a self-declaration backed by evidence. In both the UK and EU regimes the manufacturer carries the responsibility: the mark records the manufacturer’s own claim, supported by a technical file and, where the legislation demands a third party, by a conformity assessment body’s involvement. Which route applies is set by the product-specific legislation, not by the marking rules in general — so the sector regulation, not this entry, is the last word for any particular product.
Not all products require a Notified Body. Self-declaration of conformity is sufficient for lower-risk products. Notified Body assessment is required for: Class II-III medical devices, high-risk machinery (e.g., lifts, pressure vessels), PPE Category III, construction products needing Type Examination, radio equipment with new spectrum. Search for NANDO (New Approach Notified and Designated Organisations) database for EU Notified Bodies — TUV SUD, Bureau Veritas, SGS are the most commonly used by Indian exporters.
From the AJG lexicon archive (July 2026).
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