Personal Protective Equipment Regulation (PPE)

PPE Personal Protective Equipment Regulation (EU) 2016/425 · Consolidated version of 29 May 2026 · Official text on EUR-Lex

Contents of the act

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
• Article 41a – Application of emergency procedures
• Article 41b – Prioritisation of the conformity assessment of PPE designated as crisis-relevant goods
• Article 41c – Derogation from the conformity assessment procedures requiring the mandatory involvement of a notified body
• Article 41d – Presumption of conformity based on standards and common specifications
• Article 41e – Prioritisation of market surveillance activities and mutual assistance among authorities

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

Annexes

• ANNEX I – RISK CATEGORIES OF PPE
• ANNEX II – ESSENTIAL HEALTH AND SAFETY REQUIREMENTS
• ANNEX III – TECHNICAL DOCUMENTATION FOR PPE
• ANNEX IV – INTERNAL PRODUCTION CONTROL
• ANNEX V – EU TYPE-EXAMINATION
• ANNEX VI – CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL
• ANNEX VII – CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRODUCT CHECKS AT RANDOM INTERVALS
• ANNEX VIII – CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS
• ANNEX IX – EU DECLARATION OF CONFORMITY No …