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Personal Protective Equipment (PPE) Regulation In force since 21 April 2018

Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC
32016R0425 · official text on EUR-Lex

This English text is a careful, terminology-researched translation prepared by eucite.com — not an official government translation. The German original linked above is the legally authoritative text.

Articles

Chapter I GENERAL PROVISIONS

• Article 1 — Subject matter
• Article 2 — Scope
• Article 3 — Definitions
• Article 4 — Making available on the market
• Article 5 — Essential health and safety requirements
• Article 6 — Provisions concerning the use of PPE
• Article 7 — Free movement

Chapter II OBLIGATIONS OF ECONOMIC OPERATORS

• Article 8 — Obligations of manufacturers
• Article 9 — Authorised representatives
• Article 10 — Obligations of importers
• Article 11 — Obligations of distributors
• Article 12 — Cases in which obligations of manufacturers apply to importers and distributors
• Article 13 — Identification of economic operators

Chapter III CONFORMITY OF THE PPE

• Article 14 — Presumption of conformity of PPE
• Article 15 — EU declaration of conformity
• Article 16 — General principles of the CE marking
• Article 17 — Rules and conditions for affixing the CE marking

Chapter IV CONFORMITY ASSESSMENT

• Article 18 — Risk categories of PPE
• Article 19 — Conformity assessment procedures

Chapter V NOTIFICATION OF CONFORMITY ASSESSMENT BODIES

• Article 20 — Notification
• Article 21 — Notifying authorities
• Article 22 — Requirements relating to notifying authorities
• Article 23 — Information obligation on notifying authorities
• Article 24 — Requirements relating to notified bodies
• Article 25 — Presumption of conformity of notified bodies
• Article 26 — Subsidiaries of and subcontracting by notified bodies
• Article 27 — Application for notification
• Article 28 — Notification procedure
• Article 29 — Identification numbers and lists of notified bodies
• Article 30 — Changes to notifications
• Article 31 — Challenge of the competence of notified bodies
• Article 32 — Operational obligations of notified bodies
• Article 33 — Appeal against decisions of notified bodies
• Article 34 — Information obligation on notified bodies
• Article 35 — Exchange of experience
• Article 36 — Coordination of notified bodies

Chapter VI UNION MARKET SURVEILLANCE, CONTROL OF PPE ENTERING THE UNION MARKET AND UNION SAFEGUARD PROCEDURE

• Article 37 — Union market surveillance and control of PPE entering the Union market
• Article 38 — Procedure at national level for dealing with PPE presenting a risk
• Article 39 — Union safeguard procedure
• Article 40 — Compliant PPE which presents a risk
• Article 41 — Formal non-compliance

Chapter VII DELEGATED AND IMPLEMENTING ACTS

• Article 42 — Delegated power
• Article 43 — Exercise of the delegation
• Article 44 — Committee procedure

Chapter VIII TRANSITIONAL AND FINAL PROVISIONS

• Article 45 — Penalties
• Article 46 — Repeal
• Article 47 — Transitional provisions
• Article 48 — Entry into force and application