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

  1. Is the product PPE within Regulation (EU) 2016/425? If its intended purpose is protection against a risk — yes.
  2. Which category? The nature of the risk decides: minimal (I), intermediate (II), fatal or irreversible (III).
  3. 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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