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Medical Device Regulation (MDR)

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

instructions for use

Defined in Article 2, Medical Device Regulation (MDR)

Uses as of 01/12/2018

Definitions over time (1)

25/05/2017 – 24/04/2020 applies on 01/12/2018 Article 2, Medical Device Regulation (MDR) Scope: Whole act

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

‘instructions for use’ means the information provided by the manufacturer to inform the user of a device's intended purpose and proper use and of any precautions to be taken;

Other definitions of this term in this act (1)

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

Article 2(14)

Used in (39 places in 17 provisions on 01/12/2018)

Medical Device Regulation (MDR) (39 in 17)

Article 2² · Article 7 · Article 13 · Article 16 · Article 17² · Article 20 · Article 32 · Article 52 · Article 55 · Article 83 · Annex I¹⁹ · Annex II · Annex IX² · Annex VI² · Annex VII · Annex XII · Annex XV