Personal Protective Equipment (PPE) CE Marking
Europe
We manage complex PPE CE marking—so you can protect users and access the EU market.
The Personal Protective Equipment Regulation (EU) 2016/425 mandates stringent requirements based on risk. Don't let complex risk categories (I, II, III), Notified Body (Module B/C2/D) approvals, or technical documentation block your market access. We manage the entire certification pathway.
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Common certification pitfalls to avoid
Understand your fastest path to CE
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Common certification pitfalls to avoid
Supporting global consumer brands
Know your PPE category and compliance path.
PPE Classification & Compliance Assessment
We classify your PPE into Category I (simple, self-certified), Category II (intermediate), or Category III (complex/mortal risks). This classification dictates the conformity route. We identify all applicable harmonised standards (e.g., EN 388 for gloves, EN 149 for masks) and create a full project plan.
Prepare your documentation for Notified Body review.
Technical File Development & Notified Body Coordination
For Category II & III PPE, a Notified Body is mandatory. We prepare the Technical File and testing plans required for the EU Type-Examination (Module B). We then arrange the handover to the Notified Body and help you prepare for ongoing surveillance (Module C2 or D).
Launch with a compliant DoC and user instructions.
Declaration of Conformity & User Information Review
We draft the EU Declaration of Conformity (which must be provided with PPE) and compile your Technical File. We conduct a detailed review of your user instructions and markings , which have very specific requirements under the PPER, to ensure they are fully compliant.
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