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

harmonised standard

Definitions over time (1)

20/04/2016 – 29/05/2026 Article 3, Regulation (EU) 2016/425 Scope: Whole act

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

‘harmonised standard’ means a harmonised standard as defined in point (c) of point 1 of Article 2 of Regulation (EU) No 1025/2012;

Each has its own scope, dates and uses. Open one to see when it applies.

No text uses this concept on 12/11/2026.