When is EU type-examination required for PPE?
Technically reviewed: 2026-07-31
In short
EU type-examination is mandatory for every Category II and III item of personal protective equipment — that is, everything outside minimal-risk Category I. Safety footwear, mechanical-risk gloves, welding and firefighter PPE: all require type-examination. In Category I (e.g. garden gloves) the manufacturer self-assesses.
The decision logic
- Is the product PPE within Regulation (EU) 2016/425? If its intended purpose is protection against a risk — yes.
- Which category? The nature of the risk decides: minimal (I), intermediate (II), fatal or irreversible (III).
- Category I: the manufacturer self-assesses through internal production control. Category II and III: EU type-examination by a notified body is mandatory; Category III adds ongoing production surveillance.
Typical misconceptions
- “Small series don’t need it.” The obligation attaches to placing on the market, not to quantity.
- “My supplier’s certificate covers me too.” A certificate covers the type and its manufacturer. Selling under your own brand can make you the manufacturer — with your own procedure to run.
- “A test report is the same as a certificate.” No: a report records measurement results; a certificate is the outcome of a conformity-assessment procedure. The former can feed the latter, but does not replace it.
If the classification is uncertain
Settle the category question at the start of development — it can be decided from the product’s functions, target group and the manufacturer’s intent, and the cost and timeline of the certification route depend on it.
Frequently asked questions
- As an importer, do I have to start a type-examination?
- Type-examination is the manufacturer's procedure. The importer's duty is to verify it took place: a valid EU type-examination certificate exists, an EU declaration of conformity exists, and the product's marking is correct. An importer selling under its own brand name becomes a manufacturer — with the obligations that carries.
- We modified an existing product. Is a new type-examination needed?
- If the change can affect the protective function or conformity — material, construction, production technology — its impact on the certificate must be clarified with the notified body. Unreported modification is the most common way a certified product silently becomes non-conforming.
- Is occupational footwear (EN ISO 20347) also subject to type-examination?
- Yes: occupational footwear is Category II PPE even without a toecap. The category follows from the risk, not from the presence of a protective toecap.
Related standards
Where next?
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