What changes on 11/03/2023

The text in force from 24/04/2020 compared with the text from 11/03/2023.

Read the act as of 11/03/2023 · other versions: 25/05/2017 · 24/04/2020 · 20/03/2023 · 09/07/2024 · 10/01/2025 · 01/01/2026 · 19/07/2026

Chapter I

• amended Article 1 - Subject matter and scope
• amended Article 4 - Regulatory status of products

Chapter II

• amended Article 8 - Use of harmonised standards
• amended Article 15 - Person responsible for regulatory compliance
• amended Article 17 - Single-use devices and their reprocessing

Chapter III

• amended Article 34 - Functionality of Eudamed

Chapter IV

• amended Article 42 - Designation and notification procedure
• amended Article 44 - Monitoring and re-assessment of notified bodies

Chapter V › Section 2

• amended Article 59 - Derogation from the conformity assessment procedures

Chapter VI

• amended Article 73 - Electronic system on clinical investigations
• amended Article 74 - Clinical investigations regarding devices bearing the CE marking

Chapter VII › Section 2

• amended Article 88 - Trend reporting

Chapter VIII

• amended Article 103 - Medical Device Coordination Group
• amended Article 106 - Provision of scientific, technical and clinical opinions and advice

Chapter X

• amended Article 115 - Exercise of the delegation
• amended Article 119 - Amendment to Regulation (EC) No 1223/2009
• amended Article 120 - Transitional provisions
• amended Article 123 - Entry into force and date of application