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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

implantable device

Defined in Article 2, Medical Device Regulation (MDR)

Uses as of 24/12/2017

Definitions over time (1)

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

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

‘implantable device’ means any device, including those that are partially or wholly absorbed, which is intended: to be totally introduced into the human body, or to replace an epithelial surface or the surface of the eye,

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(5)

Used in (51 places in 25 provisions on 24/12/2017)

Medical Device Regulation (MDR) (51 in 25)

Recital 48 · Recital 56 · Recital 58 · Recital 63 · Article 2² · Article 10 · Article 18 · Article 27³ · Article 32 · Article 52⁴ · Article 54 · Article 61³ · Article 86 · Article 105 · Article 108 · Article 123 · Annex I⁸ · Annex IX² · Annex VI⁶ · Annex VII · Annex VIII⁴ · Annex X · Annex XI² · Annex XIII · Annex XV²