01

Start with the protected risk and real claim

Identify what the equipment worn or held by a person is intended to protect against, its model, materials, sizes and use limits. Under Regulation 2016/425 the Annex I risk determines the reasoned category. A product name, fabric or glove shape does not determine the route; exclusions must also be checked for the actual use.

Example: a glove has mechanical test results, but the new offer claims protection against a harmful chemical. The mechanical report does not establish the new protection. Define the chemical/use claim, category and applicable evidence before extending the label or assuming the existing type covers it.

02

Choose the category-specific procedure and evidence

Category I uses internal production control. Category II uses EU type-examination B and conformity-to-type C. Category III generally combines B with supervised product checks C2 or production quality assurance D; actual special provisions must be checked. A type certificate alone does not complete a required production stage.

Prepare risk/design documentation, representative samples, performance results, material/size/variant mapping, instructions and production-consistency records. Fit and compatibility with other equipment matter where relevant. Verify a required body’s PPE and procedure scope in NANDO. A material or size outside the tested configuration cannot be included without justified evidence.

03

Retain manufacturer and workplace responsibilities

The manufacturer links the final product, supported protection levels and limits to the declaration and marking. Instructions and marketing claims must remain consistent with the actual evidence. A supplier’s certificate or company ISO system is not a substitute for the product assessment and series-production duties.

Kayra can coordinate scope, records and external work but is not the notified body or test laboratory and cannot guarantee the decision. Material, design, size range or protection-claim changes need review. Product CE does not replace the employer’s workplace risk assessment, equipment selection, maintenance and actual use obligations.

04

Responsibility

Kayra supports the scope note, evidence plan and assessment coordination. It does not claim notified-body or accredited laboratory status and does not guarantee a positive result or fixed certificate date. Manufacturer and required assessment-body duties remain separate. This guide addresses the EU/EEA route; national market and operation rules need their own check.

Official sources

Reviewed: 3 October 2026. Check the current rules and assessment route for the actual product.