Frequently Asked Question

Does my product need a Notified Body for EU market access?

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.