CE marking for PPE manufactured outside the EU: the exporter's route

The rule that surprises exporters

Regulation (EU) 2016/425 — the PPE Regulation — sets requirements for the product and for the conformity assessment, not for the manufacturer’s address. A safety-shoe factory in Chennai, a glove maker in Sialkot, a leather-suit producer in Istanbul or a UK brand after Brexit can each be the named holder of an EU type-examination certificate. What is fixed is the other side of the table: the certificate must come from a notified body designated by an EU member state, listed in the European Commission’s register.

The route, step by step

1. Category check — most protective footwear, gloves and clothing are Category II; protection against irreversible harm (for example certain heat, chemical or cut risks) is Category III.
2. Harmonised standard — the product is tested against the standard that gives presumption of conformity (EN ISO 20345 for safety footwear, EN 388 for mechanical glove risks, EN ISO 11611/11612 for welding and heat, and so on).
3. Technical documentation — drawings, materials, user information, risk assessment; for the procedure, English documentation is standard practice.
4. EU type-examination (Module B) — the notified body assesses the file and tests the type samples, then issues the certificate.
5. Category III surveillance — Module C2 or D keeps series production under notified-body oversight.
6. Declaration of conformity + CE marking — drawn up by the manufacturer, on the basis of the certificate.

The whole Module B procedure can run without travelling: documentation moves electronically and samples move by courier.

One certificate, EU and Great Britain

Since 1 October 2024, the UK recognises CE marking for PPE on the Great Britain market indefinitely (Product Safety and Metrology etc. (Amendment) Regulations 2024). An exporter certifying with an EU notified body therefore covers the EU-27 and GB with a single procedure; Northern Ireland follows EU rules under the Windsor Framework. Check gov.uk for the current position before relying on it for a specific product.

Common mistakes that cost months

• Testing without the procedure — an accredited report alone does not authorise CE marking for Category II/III PPE.
• Incomplete user information — the information notice is a formal requirement of the regulation, not marketing material.
• Wrong sample count — agree the sample list with the notified body before shipping; a second courier round is the most common avoidable delay.
• Marking promises ahead of results — classes and levels (S3, cut level D, Class AAA) exist only when the measurement supports them.