Preamble
Recitals 57
Chapter I - GENERAL PROVISIONS (Article 1-7) 7
Chapter II - OBLIGATIONS OF ECONOMIC OPERATORS (Article 8-13) 6
Chapter III - CONFORMITY OF THE PPE (Article 14-17) 4
Chapter IV - CONFORMITY ASSESSMENT (Article 18-19) 2
Chapter V - NOTIFICATION OF CONFORMITY ASSESSMENT BODIES (Article 20-36) 17
Chapter VI - UNION MARKET SURVEILLANCE, CONTROL OF PPE ENTERING THE UNION MARKET AND UNION SAFEGUARD PROCEDURE (Article 37-41) 5
Chapter VIA - EMERGENCY PROCEDURES (Article 41a-41e) 5
Chapter VII - DELEGATED AND IMPLEMENTING ACTS (Article 42-44) 3
Chapter VIII - TRANSITIONAL AND FINAL PROVISIONS (Article 45-48) 4
Annexes 10

Union harmonisation legislation

Definitions over time (1)

29/05/2026 – today applies on 10/11/2026 Article 3, Regulation (EU) 2016/425 Scope: Whole act

For the purposes of this Regulation, the following definitions apply:

‘Union harmonisation legislation’ means any Union legislation harmonising the conditions for the marketing of products;

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