[Home](/)/[Resources](/resources)/PPE Regulation CE marking EURegulation guide # PPE Regulation (EU) 2016/425: CE Marking for Protective Equipment PPE CE marking is category-driven. The product's risk protection level — not the product type — determines whether you can self-certify or must involve a Notified Body. Misclassifying a Category III product as Category II is one of the most common and serious compliance failures in this space. Copy Link[Share on WhatsApp](https://wa.me/?text=https%3A%2F%2Fkrono-labs.com%2Fguides%2Fppe-regulation-ce-marking) At a glance PPE categories 3 Key standards 7 Technical file items 8 ## PPE categories and conformity routes Category I ### Minimal risk **Examples:** Gardening gloves, sunglasses for non-industrial use, simple protective clothing for minor cuts and abrasions. **Conformity route:** Module A — manufacturer self-certifies. No Notified Body required. Manufacturer draws up Declaration of Conformity and affixes CE mark. Category II ### Intermediate risk — hazards not covered by Category I or III NB required **Examples:** Safety helmets for construction, high-visibility clothing, safety shoes (EN ISO 20345), protective gloves for chemical handling at intermediate risk. **Conformity route:** Module B (EU type-examination by NB) + Module C (conformity to type). Notified Body issues EU type-examination certificate. Category III ### Severe risk — irreversible or mortal injury NB required **Examples:** Respiratory protection (face masks, respirators), fall-protection harnesses, protective equipment against electric arcs, high-voltage gloves, chemical protection suits. **Conformity route:** Module B + Module C2, D, or F. NB type examination plus production QA or product verification. Most rigorous route. ## Key harmonised standards EN ISO 20345 Personal protective equipment — safety footwear EN 397 Industrial safety helmets — shock absorption and penetration resistance EN ISO 374-1 Protective gloves against dangerous chemicals and micro-organisms EN 166 Personal eye protection — specifications EN 149 Respiratory protective devices — filtering half masks (FFP classifications) EN 361 Personal protective equipment against falls from a height — full body harnesses EN ISO 11612 Protective clothing against heat and flame ## Technical file checklist 01 Product description and intended use, including risk category classification rationale 02 Design drawings, manufacturing specifications, and bill of materials 03 EU type-examination certificate number and issuing Notified Body (Category II and III) 04 List of harmonised standards applied with OJ citation verification 05 Test reports from accredited laboratories 06 Risk assessment covering all identified hazards 07 User information and instructions in all required languages 08 Quality management documentation (Category III) ## Frequently asked questions ### What changed when the PPE Directive became the PPE Regulation? The PPE Regulation (EU) 2016/425 replaced the old PPE Directive 89/686/EEC from April 2019. The core category system remained similar, but the Regulation introduced more detailed obligations for economic operators (manufacturers, importers, distributors), stronger requirements for instructions and information, and clearer rules on the EU Authorised Representative role. Products certified under the old directive needed reassessment. ### Is a face mask (surgical mask) covered by the PPE Regulation? Surgical masks primarily intended to protect the patient from the wearer are Medical Devices (MDR), not PPE. Masks intended to protect the wearer from the environment — filtering face pieces (FFP1, FFP2, FFP3) — are Category III PPE under EN 149. Some products are dual-use and must comply with both frameworks. The intended use stated on the packaging is the key determining factor. ### Can the same PPE be certified under multiple categories? No — a PPE product has a single category classification based on its worst-case risk protection function. If a product provides protection against both intermediate and severe risks, it is classified as Category III overall, and the most stringent conformity route (Module B+C2/D/F) applies to the whole product. ### How long does a PPE EU type-examination certificate last? EU type-examination certificates for PPE are typically issued with a validity period set by the Notified Body — often five years. They can be withdrawn or suspended if the Notified Body identifies that the product no longer meets the certified standards. Manufacturers must notify their NB of any design changes, and significant changes require a new examination. **Disclaimer:** Educational resource only. PPE category classification can have life-safety consequences — verify your classification with a qualified engineer or your Notified Body before placing any PPE on the EU market. 🇪🇺 CE Marking roadmap for PPE Every standard, document, and test that applies — free, no account required. See your free roadmap[ Want an expert to take PPE through 🇪🇺 CE Marking compliance for you? One consultant from Krono's compliance team takes your product from requirements to legal sale, with a fixed quote before any work starts. 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