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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

medical device

Defined in Article 2, Medical Device Regulation (MDR)

Uses as of 01/06/2017

Definitions over time (1)

25/05/2017 – 24/04/2020 applies on 01/06/2017 Article 2, Medical Device Regulation (MDR) Scope: Whole act

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

‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability, investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,

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(1)

Used in (116 places in 55 provisions on 01/06/2017)

Medical Device Regulation (MDR) (116 in 55)

Recital 1³ · Recital 2⁴ · Recital 3 · Recital 4 · Recital 5² · Recital 6⁴ · Recital 7² · Recital 8 · Recital 9 · Recital 10² · Recital 11 · Recital 12 · Recital 19³ · Recital 22 · Recital 23 · Recital 30 · Recital 37 · Recital 44² · Recital 45 · Recital 56 · Recital 64 · Recital 71 · Recital 82⁶ · Recital 86² · Recital 95 · Recital 98 · Recital 101² · Preamble · Article 1⁸ · Article 2⁷ · Article 4⁵ · Article 15⁶ · Article 22 · Article 26² · Article 27 · Article 33 · Article 35² · Article 40 · Article 46⁴ · Article 49² · Article 61 · Article 78 · Article 102 · Article 103⁸ · Article 106³ · Article 107² · Article 114 · Article 117 · Article 118 · Article 121 · Annex I² · Annex III · Annex VI · Annex VII · Annex VIII²