EU regulation
PPE Regulation: risk categories, evidence and CE marking
Overview
Short answer
Regulation (EU) 2016/425 governs personal protective equipment made available on the EU market. Intended protection and risk category determine conformity assessment. Under the ordinary procedure, the manufacturer needs technical documentation and an EU declaration before CE marking can be used. Art. 1-3,8,18-19.
Legal status
Law in force
The Regulation is in force. This review covers the consolidation of 29 May 2026, including Regulation (EU) 2024/2748 and its corrigendum. Chapter VIa contains conditional emergency procedures; this overview describes ordinary assessment.
Part 1
Protection determines scope
PPE includes equipment worn or held to protect a person against health or safety risks. Certain interchangeable components and connection systems are also covered. Exclusions include equipment specifically designed for military or law-enforcement use and certain private-use equipment against ordinary weather. Assess intended function, not only the product name. Art. 2-3.
Part 2
Determine category before planning tests
Annex I divides risks into categories I, II and III. Category I contains expressly listed minimal risks. Category III contains listed risks with very serious consequences, such as falls from height and harmful noise. Category II covers the remaining risks. Record the protection claims made for your product and the category they entail. Art. 18; Annex I.
Part 3
Type examination and production control
Category I uses internal production control. Category II requires EU type-examination followed by conformity to type. Category III normally also requires supervised product checks or production quality assurance. Article 19 provides a specific derogation for category III PPE produced as a single unit for an individual user. Select the procedure for the actual product. Art. 19; Annex IV-VIII.
Part 4
Evidence must concern the same equipment
Annex III requires a description of the equipment and intended use, risk assessment, applicable requirements and design evidence, among other items. Tests, materials and instructions need to match the version sold. The manufacturer retains technical documentation and the EU declaration for ten years after placing on the market. Treat supplier or material changes as decisions requiring review. Art. 8.3-4; Annex III.
Part 5
What the importer needs to verify
The importer verifies that the manufacturer completed the appropriate assessment and prepared technical documentation, and that markings and accompanying documents are present. For category III using production control under module C2 or D, CE marking is followed by the identification number of the body involved in production control. Check that documents identify the model and protective function ordered, packaged and described in instructions. Art. 10,17.
Part 6
Emergency rules have specific conditions
Amendment 2024/2748 introduced emergency procedures. They require designated crisis-relevant goods, an activated emergency mode and relevant EU decisions. A general reference to shortages therefore does not justify omitting a notified body. In ordinary work, decide category, assessment procedure and evidence together and revisit them when the product design changes. Art. 8.4,41a-41e.
Checklist
Key takeaways
- Start with the risk the equipment is intended to protect against.
- Categories I, II and III follow different assessment procedures.
- A type-examination certificate does not replace other manufacturer duties.
- Link materials, tests and instructions to the correct design.
Questions and answers
Frequently asked questions
Does all PPE require a notified body?
No. Category I uses internal production control under the ordinary procedure. Art. 19(a).
Is an EU type-examination certificate enough?
No. Manufacturer duties, the production procedure, documentation and marking remain. Art. 8,19.
Does the product name determine the category?
No. Start with the risks the equipment is intended to protect against. Art. 18; Annex I.
Does the Regulation only cover workplace equipment?
No. Private-use equipment can also be covered; check the specified exclusions. Art. 2-3.
Further reading
Official sources
How Verca helps
How Verca can support the process
Verca can connect product structure and documentation to the correct product version. This provides a shared place for the evidence behind an assessment and makes changes easier to follow. The company remains responsible for identifying applicable requirements, evaluating evidence and making product decisions. Verca platform description.