What is EU type-examination (module B) in product compliance?

Dutch term: EU-typeonderzoek (module B) | Legal basis: Decision 768/2008/EC + sector-specific legislation

EU type-examination (module B) is a conformity assessment procedure in which a notified body examines the technical design of a product (or a representative sample) and verifies that it meets the essential requirements of the applicable EU harmonised legislation. The result is an EU type-examination certificate, which confirms that the product type complies with the applicable requirements.

Module B is the examination phase; it must be followed by a production-phase module (C, D, E or F) that ensures ongoing production conformity. The combination of modules (B+C, B+D, B+F, etc.) is specified in the applicable directive or regulation and depends on the risk level of the product. The notified body assesses the technical documentation, may perform or commission tests, and issues the certificate for a defined period (typically five years, renewable).

Why it matters for international businesses

For manufacturers of higher-risk products (certain machinery categories, medical devices, pressure equipment, personal protective equipment, pyrotechnics), the EU type-examination is a mandatory gateway to the EU market. Engaging the right notified body early in the product development cycle ensures that design decisions align with the essential requirements before production investment.