Product Safety · Hazloc Labs

EU PPE Regulation 2016/425: Categories and Conformity Paths

Personal protective equipment placed on the EU market falls under Regulation (EU) 2016/425. Unlike many electronics that self-declare under LVD/EMC, PPE categories often require Notified Body involvement — especially Category III.

Categories (simplified)

CategoryRisk levelTypical conformity flavor
IMinimal risksManufacturer module with technical documentation
IIRisks neither minimal nor deadly/irreversible (mid)EU-type examination by a Notified Body commonly required
IIIRisks that may cause death or irreversible damageType examination plus production quality surveillance modules

What product teams forget

Related: self-certification vs Notified Body and CE CoC guide.

Need a scoped path? Hazloc Labs helps multi-directive products (PPE + electronics) structure evidence. Book a consultation.

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