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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

system

Defined in Article 2, Medical Device Regulation (MDR)

Uses as of 20/12/2017

Definitions over time (1)

25/05/2017 – 24/04/2020 applies on 20/12/2017 Article 2, Medical Device Regulation (MDR) Scope: Whole act

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

‘system’ means a combination of products, either packaged together or not, which are intended to be inter-connected or combined to achieve a specific medical purpose;

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(11)

Used in (328 places in 76 provisions on 20/12/2017)

Medical Device Regulation (MDR) (328 in 76)

Recital 30 · Recital 32⁴ · Recital 33 · Recital 41⁴ · Recital 42² · Recital 43 · Recital 44 · Recital 46⁴ · Recital 47² · Recital 50 · Recital 67³ · Recital 74² · Recital 75 · Recital 85 · Recital 96³ · Recital 97 · Article 2² · Article 5 · Article 8³ · Article 10⁹ · Article 13 · Article 15⁵ · Article 16³ · Article 17² · Article 22¹⁰ · Article 27¹⁷ · Article 29³ · Article 30³ · Article 31⁵ · Article 33¹³ · Article 40 · Article 42 · Article 43 · Article 44² · Article 46³ · Article 47 · Article 53 · Article 54 · Article 55 · Article 56 · Article 57² · Article 63² · Article 69² · Article 70⁴ · Article 73³ · Article 74 · Article 75 · Article 76² · Article 77⁴ · Article 78⁴ · Article 80³ · Article 81 · Article 83⁵ · Article 84 · Article 86³ · Article 87 · Article 88 · Article 89⁴ · Article 90² · Article 92¹⁰ · Article 93³ · Article 95⁴ · Article 97 · Article 98 · Article 99 · Article 100² · Article 106 · Annex ES² · Annex I¹³ · Annex II² · Annex IX⁴¹ · Annex VI²³ · Annex VII³¹ · Annex VIII¹³ · Annex XI⁷ · Annex XII⁵