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Preamble
Recitals 101
Chapter I - SCOPE AND DEFINITIONS (Article 1-4) 4
Chapter II - MAKING AVAILABLE ON THE MARKET AND PUTTING INTO SERVICE OF DEVICES, OBLIGATIONS OF ECONOMIC OPERATORS, REPROCESSING, CE MARKING, FREE MOVEMENT (Article 5-24) 20
Chapter III - IDENTIFICATION AND TRACEABILITY OF DEVICES, REGISTRATION OF DEVICES AND OF ECONOMIC OPERATORS, SUMMARY OF SAFETY AND CLINICAL PERFORMANCE, EUROPEAN DATABASE ON MEDICAL DEVICES (Article 25-34) 10
Chapter IV - NOTIFIED BODIES (Article 35-50) 16
Chapter V - CLASSIFICATION AND CONFORMITY ASSESSMENT (Article 51-60) 10
Chapter VI - CLINICAL EVALUATION AND CLINICAL INVESTIGATIONS (Article 61-82) 22
Chapter VII - POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE (Article 83-100) 18
Chapter VIII - COOPERATION BETWEEN MEMBER STATES, MEDICAL DEVICE COORDINATION GROUP, EXPERT LABORATORIES, EXPERT PANELS AND DEVICE REGISTERS (Article 101-108) 8
Chapter IX - CONFIDENTIALITY, DATA PROTECTION, FUNDING AND PENALTIES (Article 109-113) 5
Chapter X - FINAL PROVISIONS (Article 114-123) 10
Annexes 18
- Annex ES
- Annex I
- Annex II
- Annex III
- Annex IV
- Annex V
- Annex VI
- Annex VII
- Annex VIII
- Annex IX
- Annex X
- Annex XI
- Annex XII
- Annex XIII
- Annex XIV
- Annex XV
- Annex XVI
- Annex XVII

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New version applies from 24/04/2020. 125 provisions change. Later versions: 11/03/2023, 20/03/2023, 09/07/2024, 10/01/2025, 01/01/2026, 19/07/2026. Article 118 changes in this version: compare with the current text.

View as of 24/04/2020 What changes

Article 118 - Amendment to Regulation (EC) No 178/2002

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Article 118

Amendment to Regulation (EC) No 178/2002

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In the third paragraph of Article 2 of Regulation (EC) No 178/2002, the following point is added:

((i))

medical devices within the meaning of Regulation (EU) 2017/745 of the European Parliament and of the Council (^*2).

Official text · the act as published Open full page ↗

Metadata

✓ In force

↻ Amendments (2)

24/04/2020 current
25/05/2017
05/05/2017 first version in the database

Used here (1)

medical device1