What changes on 29/05/2026

The text in force from 20/04/2016 compared with the text from 29/05/2026.

Read the act as of 29/05/2026 · other versions:

Chapter I

• amended Article 2 - Scope
• amended Article 3 - Definitions
• amended Article 7 - Free movement

Chapter II

• amended Article 8 - Obligations of manufacturers
• amended Article 9 - Authorised representatives
• amended Article 10 - Obligations of importers
• amended Article 11 - Obligations of distributors
• amended Article 13 - Identification of economic operators

Chapter III

• amended Article 15 - EU declaration of conformity
• amended Article 17 - Rules and conditions for affixing the CE marking

Chapter IV

• amended Article 19 - Conformity assessment procedures

Chapter V

• amended Article 21 - Notifying authorities
• amended Article 22 - Requirements relating to notifying authorities
• amended Article 24 - Requirements relating to notified bodies
• amended Article 26 - Subsidiaries of and subcontracting by notified bodies
• amended Article 27 - Application for notification
• amended Article 28 - Notification procedure
• amended Article 29 - Identification numbers and lists of notified bodies
• amended Article 30 - Changes to notifications
• amended Article 31 - Challenge of the competence of notified bodies
• amended Article 32 - Operational obligations of notified bodies
• amended Article 34 - Information obligation on notified bodies

Chapter VI

• amended Article 38 - Procedure at national level for dealing with PPE presenting a risk
• amended Article 39 - Union safeguard procedure
• amended Article 40 - Compliant PPE which presents a risk
• amended Article 41 - Formal non-compliance

Chapter VIA

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

Chapter VII

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

Chapter VIII

• amended Article 45 - Penalties
• amended Article 47 - Transitional provisions
• amended Article 48 - Entry into force and application

Outside any heading

• amended Annex I - RISK CATEGORIES OF PPE
• amended Annex II - ESSENTIAL HEALTH AND SAFETY REQUIREMENTS
• amended Annex III - TECHNICAL DOCUMENTATION FOR PPE
• amended Annex IV - INTERNAL PRODUCTION CONTROL
• amended Annex IX - EU DECLARATION OF CONFORMITY No …(4)
• amended Annex V - EU TYPE-EXAMINATION
• amended Annex VI - CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL
• amended Annex VII - CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRODUCT CHECKS AT RANDOM INTERVALS
• amended Annex VIII - CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS
• amended Annex X - CORRELATION TABLE