CE marking is the gateway to the European market for personal protective equipment. Without it, PPE cannot legally be placed on the EU market — regardless of how good the product is. For brands importing PPE from Taiwan or any non-EU country, understanding what CE actually requires is not optional.
What is covered by EU PPE Regulation 2016/425
The EU PPE Regulation (EU) 2016/425 came into force on 21 April 2018. It covers "equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person's health or safety."
For Power Honour's core product areas, this includes: - Carabiners, connectors, and anchor devices used in fall protection (EN 362, EN 795) - Full-body harnesses and work-positioning systems (EN 361, EN 358) - Self-retracting lifelines and lanyards (EN 360, EN 354, EN 355) - Helmets for climbing and industrial work (EN 397, EN 12492) - Ice tools and crampons used in mountaineering (CE EN certification path varies by standard)
It does not cover general hardware, fasteners, or structural components that are not themselves the protective device — though those components must comply with the materials and manufacturing standards specified in the relevant EN standards.
Understanding the three PPE categories
Category I — Minimal risk: Products that protect against minor risks only (gardening gloves, sunglasses). The manufacturer self-declares conformity. No third-party involvement required.
Category II — Intermediate risk: Products that are neither Category I nor Category III. Requires type examination by a notified body (a government-accredited testing lab). The notified body issues an EU Type Examination Certificate.
Category III — Irreversible or fatal risk: This covers most fall-protection and climbing products. In addition to notified body type examination, the manufacturer must implement either random product checks by the notified body or a certified quality system (ISO 9001) under notified body supervision. This is the most rigorous category and requires ongoing surveillance after initial certification.
Almost all fall-protection hardware, life-critical connectors, and load-bearing climbing gear falls under Category III. Brands should not assume Category II without checking with their notified body.
The CE certification process: step by step
Step 1 — Identify the applicable harmonised standards. For example, for a carabiner: EN 362 (connectors), EN 365 (general requirements for PPE for protection against falls). Harmonised standards are published in the EU Official Journal. Your notified body can confirm which apply.
Step 2 — Select a notified body. Notified bodies for PPE (EU) 2016/425 are listed in the NANDO database. For Category III products, the notified body must be accredited for the specific product type. Power Honour works with several accredited labs across Europe and can facilitate coordination.
Step 3 — Prepare samples for type examination. The notified body tests samples against the applicable standards' requirements — typically including static tensile load, dynamic load, gate-open load (for carabiners), corrosion resistance, and dimensional compliance.
Step 4 — Build the technical file. The technical file is the manufacturer's complete documentation package: product drawings, material specs, test reports, risk assessment, instructions for use (IFU) in required EU languages, and the Declaration of Conformity (DoC). This file must be retained for 10 years and made available to authorities on request.
Step 5 — Issue the Declaration of Conformity. The DoC declares which standards are met, names the notified body, and is signed by the manufacturer. CE marking is then applied to the product and/or packaging.
Step 6 — For Category III, arrange ongoing surveillance. This means either quarterly random product checks shipped to the notified body, or a quality management system audit programme.
Common mistakes that cause re-testing
Design changes without notified body notification. Even small dimensional changes to a load-bearing component can invalidate a CE Type Examination Certificate. Any change to materials, geometry, or manufacturing process should be assessed for certification impact before production.
Incomplete IFU. Instructions for use must be in all official languages of the countries where the product is sold. Missing language versions are a common compliance gap found during market surveillance.
Incorrect CE marking format. CE marking has specific size requirements (minimum 5mm height) and must appear on the product or, where not possible, on the packaging and accompanying documentation. It cannot appear only on a website or catalogue.
Missing post-market surveillance. Category III requires ongoing market surveillance — collecting field feedback, monitoring incidents, and updating the technical file. This is not a one-time certification exercise.
Power Honour's role in your CE journey
We support the full process: test sample preparation, notified body coordination (Europe, US, Asia), technical file drafting, factory audit readiness, and Declaration of Conformity documentation. For brands entering the EU market for the first time, we typically recommend starting with a pre-assessment consultation to map out the standards, timeline, and budget before committing to product development.