Every regime ยท European Union
PPE Regulation (EU) 2016/425
Personal protective equipment in three categories by the risk it protects against. Category I is self-declared; categories II and III need an EU type-examination certificate from a notified body, and category III needs ongoing conformity surveillance with the notified body number beside the CE mark.
named This regime is named, not quoted: what it covers and the documents it expects are described in our own words, and no requirement text is reproduced. On the sheet its chip is outlined; a product whose regimes are all named stands as reference.
What it expects in the file
- Technical file
The technical documentation: design, drawings, bill of materials, the standards applied, the conformity assessment route, and the evidence that the requirements are met. Kept for the retention period the regime sets, typically ten years from the last unit placed on the market. - Declaration of conformity
The EU or UK declaration of conformity (or the food-contact declaration of compliance), signed by the manufacturer, naming the product, the legislation and the standards, and the notified or approved body where one was involved. - Risk assessment
The documented hazard identification and risk assessment for the product across its lifecycle, updated when the design, the use or the field data changes. - Test reports
Test reports from an accredited or accepted laboratory against the standards the technical file names, tied to the exact model and revision tested. - Labelling and instructions
Markings on the product and packaging (conformity mark, identification, warnings, manufacturer and importer details) and the instructions and safety information in the language of the market. - Third-party certificate
A type-examination certificate, notified or approved body certificate, or listing from a recognised laboratory, with the scope and the expiry.
Product categories that engage it
See which of your products engage it
Paste the list and every product that engages PPE Reg in the markets you sell to shows it as a chip, with the documents it expects ticked against what you hold. Five products free, no account.
Build my conformity sheet