How does the PPE Regulation affect product compliance?

Dutch term: PBM-verordening | Legal basis: Regulation (EU) 2016/425

The PPE Regulation (Regulation (EU) 2016/425 on Personal Protective Equipment) governs products designed to be worn or held by a person for protection against one or more health and safety risks. It covers three risk categories (I, II, III) with increasingly stringent conformity assessment requirements. Category III (protection against mortal danger) requires EU type-examination plus ongoing production monitoring by a notified body.

Manufacturers must carry out the applicable conformity assessment, compile technical documentation, draw up the EU Declaration of Conformity, affix the CE marking, and provide instructions and information in the language of the member state where the PPE is made available. The PPE must meet the essential health and safety requirements set out in Annex II of the regulation.

Why it matters for international businesses

For PPE manufacturers and importers, the risk category determines the level of notified body involvement and the ongoing compliance obligations. MAAK Advocaten advises on PPE compliance and on the contractual allocation of obligations between manufacturers and distributors.