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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

performance

Defined in Article 2, Medical Device Regulation (MDR)

Uses as of 26/07/2019

Definitions over time (1)

25/05/2017 – 24/04/2020 applies on 26/07/2019 Article 2, Medical Device Regulation (MDR) Scope: Whole act

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

‘performance’ means the ability of a device to achieve its intended purpose as stated by the manufacturer;

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(22)

Used in (185 places in 50 provisions on 26/07/2019)

Medical Device Regulation (MDR) (185 in 50)

Recital 5 · Recital 10 · Recital 16 · Recital 18 · Recital 22 · Recital 23 · Recital 30 · Recital 38 · Recital 48 · Recital 49 · Recital 61 · Recital 63² · Recital 92 · Article 1⁷ · Article 2⁷ · Article 5⁸ · Article 7 · Article 9² · Article 10 · Article 13 · Article 17⁴ · Article 23³ · Article 32⁵ · Article 35 · Article 45 · Article 55² · Article 57 · Article 61¹³ · Article 62² · Article 71² · Article 81 · Article 83³ · Article 93 · Article 101 · Article 105³ · Article 106¹² · Article 108 · Article 117² · Annex ES · Annex I¹⁹ · Annex II⁹ · Annex III · Annex IX⁵ · Annex VI³ · Annex VII¹⁴ · Annex VIII⁶ · Annex X³ · Annex XIII⁴ · Annex XIV⁹ · Annex XV¹²