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New version applies from 20/04/2016.
116 provisions change.
Later versions: 29/05/2026.
Regulation (EU) 2016/425
20/04/2016 → 29/05/2026: 5 inserted · 0 removed · 42 amended · 0 moved · 10 renamed · 74 unchanged
Position-only shifts inside the same heading are not changes. Amended = the printed text changed.
Preamble
Preamble · 1 unchanged
Recitals
Recitals · 57 unchanged
Recital 1 · Recital 2 · Recital 3 · Recital 4 · Recital 5 · Recital 6 · Recital 7 · Recital 8 · Recital 9 · Recital 10 · Recital 11 · Recital 12 · Recital 13 · Recital 14 · Recital 15 · Recital 16 · Recital 17 · Recital 18 · Recital 19 · Recital 20 · Recital 21 · Recital 22 · Recital 23 · Recital 24 · Recital 25 · Recital 26 · Recital 27 · Recital 28 · Recital 29 · Recital 30 · Recital 31 · Recital 32 · Recital 33 · Recital 34 · Recital 35 · Recital 36 · Recital 37 · Recital 38 · Recital 39 · Recital 40 · Recital 41 · Recital 42 · Recital 43 · Recital 44 · Recital 45 · Recital 46 · Recital 47 · Recital 48 · Recital 49 · Recital 50 · Recital 51 · Recital 52 · Recital 53 · Recital 54 · Recital 55 · Recital 56 · Recital 57
Chapter I - GENERAL PROVISIONS
- amended Article 2 - Scope Chapter I
- amended Article 3 - Definitions Chapter I
- amended Article 7 - Free movement Chapter I
Chapter II - OBLIGATIONS OF ECONOMIC OPERATORS
- amended Article 8 - Obligations of manufacturers Chapter II
- amended Article 9 - Authorised representatives Chapter II
- amended Article 10 - Obligations of importers Chapter II
- amended Article 11 - Obligations of distributors Chapter II
- amended Article 13 - Identification of economic operators Chapter II
Chapter II · 1 unchanged
Chapter III - CONFORMITY OF THE PPE
- amended Article 15 - EU declaration of conformity Chapter III
- amended Article 17 - Rules and conditions for affixing the CE marking Chapter III
Chapter III · 2 unchanged
Chapter IV - CONFORMITY ASSESSMENT
- amended Article 19 - Conformity assessment procedures Chapter IV
Chapter IV · 1 unchanged
Chapter V - NOTIFICATION OF CONFORMITY ASSESSMENT BODIES
- amended Article 21 - Notifying authorities Chapter V
- amended Article 22 - Requirements relating to notifying authorities Chapter V
- amended Article 24 - Requirements relating to notified bodies Chapter V
- amended Article 26 - Subsidiaries of and subcontracting by notified bodies Chapter V
- amended Article 27 - Application for notification Chapter V
- amended Article 28 - Notification procedure Chapter V
- amended Article 29 - Identification numbers and lists of notified bodies Chapter V
- amended Article 30 - Changes to notifications Chapter V
- amended Article 31 - Challenge of the competence of notified bodies Chapter V
- amended Article 32 - Operational obligations of notified bodies Chapter V
- amended Article 34 - Information obligation on notified bodies Chapter V
Chapter V · 6 unchanged
Article 20 · Article 23 · Article 25 · Article 33 · Article 35 · Article 36
Chapter VI - UNION MARKET SURVEILLANCE, CONTROL OF PPE ENTERING THE UNION MARKET AND UNION SAFEGUARD PROCEDURE
- amended Article 38 - Procedure at national level for dealing with PPE presenting a risk Chapter VI
- amended Article 39 - Union safeguard procedure Chapter VI
- amended Article 40 - Compliant PPE which presents a risk Chapter VI
- amended Article 41 - Formal non-compliance Chapter VI
Chapter VI · 1 unchanged
Chapter VIA - EMERGENCY PROCEDURES inserted
- inserted Article 41a - Application of emergency procedures Chapter VIA
- inserted Article 41b - Prioritisation of the conformity assessment of PPE designated as crisis-relevant goods Chapter VIA
- inserted Article 41c - Derogation from the conformity assessment procedures requiring the mandatory involvement of a notified body Chapter VIA
- inserted Article 41d - Presumption of conformity based on standards and common specifications Chapter VIA
- inserted Article 41e - Prioritisation of market surveillance activities and mutual assistance among authorities Chapter VIA
Chapter VII - DELEGATED AND IMPLEMENTING ACTS
- amended Article 42 - Delegated power Chapter VII
- amended Article 43 - Exercise of the delegation Chapter VII
- amended Article 44 - Committee procedure Chapter VII
Chapter VIII - TRANSITIONAL AND FINAL PROVISIONS
- amended Article 45 - Penalties Chapter VIII
- amended Article 47 - Transitional provisions Chapter VIII
- amended Article 48 - Entry into force and application Chapter VIII
Chapter VIII · 1 unchanged
Annexes
- amendedrenamed Annex I - RISK CATEGORIES OF PPE was “Annex I”
- amendedrenamed Annex II - ESSENTIAL HEALTH AND SAFETY REQUIREMENTS was “Annex II”
- amendedrenamed Annex III - TECHNICAL DOCUMENTATION FOR PPE was “Annex III”
- amendedrenamed Annex IV - INTERNAL PRODUCTION CONTROL was “Annex IV”
- amendedrenamed Annex V - EU TYPE-EXAMINATION was “Annex V”
- amendedrenamed Annex VI - CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL was “Annex VI”
- amendedrenamed Annex VII - CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRODUCT CHECKS AT RANDOM INTERVALS was “Annex VII”
- amendedrenamed Annex VIII - CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS was “Annex VIII”
- amendedrenamed Annex IX - EU DECLARATION OF CONFORMITY No …(4) was “Annex IX”
- amendedrenamed Annex X - CORRELATION TABLE was “Annex X”