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PPE & Protective Equipment Compliance

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    PPE & Protective Equipment Compliance

    CE marking, conformity assessment coordination, and EU representation for PPE manufacturers.

    • PPE Regulation 2016/425

      Full regulatory compliance review.

    • Risk Category Classification

      Cat I/II/III determination.

    • Notified Body Coordination

      For Cat II/III products.

    • Technical File

      Documentation compilation.

    • Declaration of Conformity

      EU DoC review.

    • EU Authorised Rep

      Amsterdam-based presence.

    What You Need

    Personal Protective Equipment (PPE) sold in the EU must comply with PPE Regulation (EU) 2016/425. Products are classified into three risk categories: Category I (minimal risk — e.g., gardening gloves), Category II (intermediate risk — e.g., safety glasses, high-visibility clothing), and Category III (serious/fatal risk — e.g., respiratory protection, fall protection). Category II and III products require third-party conformity assessment by a Notified Body. You need a Declaration of Conformity, a technical file, and an EU Authorised Representative.

    • EU Market Access
    • Surveillance Liaison
    • Labeling Review
    • Regulatory Support

    What We Do

    We coordinate CE marking for PPE products across all three categories. We help determine which risk category your product falls into, coordinate conformity assessment with Notified Bodies for Category II/III products, compile or review your technical file, and serve as your EU Authorised Representative.

    PPE compliance starts at €2,490/year. Book a call for a custom quote.