Does the EU type-examination certificate name the foreign manufacturer?

Yes. The certificate is issued to the manufacturer identified in the technical documentation, wherever it is established. Buyers and market-surveillance authorities can match the certificate to the product and the factory behind it.

Is an accredited test report from our own country enough for CE?

No. For Category II and III PPE, CE marking requires an EU type-examination certificate issued by an EU notified body. The report does not replace that procedure, but it can be submitted to it: BIMEO assesses existing test reports first and determines what can be used and what additional testing, if any, is required. Under BIMEO's acceptance procedure, eligible test reports may be accepted up to 10 years after testing, subject to technical review; this does not mean that every report remains automatically acceptable for 10 years.

What does Category III add on top of the certificate?

Category III PPE (for example most respiratory, chemical and fall protection, and certain gloves and clothing against irreversible harm) additionally requires ongoing conformity assessment — Module C2 (supervised product checks) or Module D (audits of the quality system), at least once a year — with a notified body of the manufacturer's choice. The CE marking is then followed by that body's identification number.

Who carries the obligations when the product lands in the EU?

The manufacturer holds the technical file and the declaration of conformity; the importer must verify that the PPE is CE-marked and documented before placing it on the market. An economic operator established in the EU must be responsible for the product (Regulation (EU) 2019/1020, Article 4): usually the importer; appointing an authorised representative is optional under the PPE Regulation.

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

Technically reviewed: 2026-08-01

In short

A manufacturer established outside the EU can CE-mark PPE: Regulation (EU) 2016/425 does not require the manufacturer to be in the EU. The EU type-examination certificate must come from an EU notified body, and an economic operator established in the EU (usually the importer) must be responsible for the product on the EU market (Regulation (EU) 2019/1020, Article 4). The procedure runs remotely: English technical documentation, samples by courier, certificate to the manufacturer. Since October 2024, Great Britain recognises CE-marked PPE indefinitely, so one certificate serves both markets.

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

Category check — most protective footwear, gloves and clothing are Category II; protection against irreversible harm (for example high heat, hazardous chemicals or hand-held chainsaws) is Category III.
Applicable standard — the product is tested against the standard that applies to it; harmonised standards (EN ISO 20345 for safety footwear, EN 388 for mechanical glove risks) additionally give the presumption of conformity.
Technical documentation — drawings, materials, user information, risk assessment; for the procedure, English documentation is standard practice.
EU type-examination (Module B) — the notified body assesses the file and tests the type samples; where the type meets the requirements, it issues the certificate.
Category III: ongoing conformity assessment — Module C2 or D keeps series production under notified-body oversight.
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.

Frequently asked questions

Does the EU type-examination certificate name the foreign manufacturer?: Yes. The certificate is issued to the manufacturer identified in the technical documentation, wherever it is established. Buyers and market-surveillance authorities can match the certificate to the product and the factory behind it.
Is an accredited test report from our own country enough for CE?: No. For Category II and III PPE, CE marking requires an EU type-examination certificate issued by an EU notified body. The report does not replace that procedure, but it can be submitted to it: BIMEO assesses existing test reports first and determines what can be used and what additional testing, if any, is required. Under BIMEO's acceptance procedure, eligible test reports may be accepted up to 10 years after testing, subject to technical review; this does not mean that every report remains automatically acceptable for 10 years.
What does Category III add on top of the certificate?: Category III PPE (for example most respiratory, chemical and fall protection, and certain gloves and clothing against irreversible harm) additionally requires ongoing conformity assessment — Module C2 (supervised product checks) or Module D (audits of the quality system), at least once a year — with a notified body of the manufacturer's choice. The CE marking is then followed by that body's identification number.
Who carries the obligations when the product lands in the EU?: The manufacturer holds the technical file and the declaration of conformity; the importer must verify that the PPE is CE-marked and documented before placing it on the market. An economic operator established in the EU must be responsible for the product (Regulation (EU) 2019/1020, Article 4): usually the importer; appointing an authorised representative is optional under the PPE Regulation.

Related standards

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