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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

manufacturer

Defined in Article 2, Medical Device Regulation (MDR)

Uses as of 01/09/2017

Definitions over time (1)

25/05/2017 – 24/04/2020 applies on 01/09/2017 Article 2, Medical Device Regulation (MDR) Scope: Whole act

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

‘manufacturer’ means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark;

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(30)

Used in (578 places in 91 provisions on 01/09/2017)

Medical Device Regulation (MDR) (578 in 91)

Recital 12² · Recital 15² · Recital 19 · Recital 22 · Recital 29 · Recital 31 · Recital 32² · Recital 34 · Recital 35⁵ · Recital 36 · Recital 38³ · Recital 45 · Recital 46 · Recital 48 · Recital 51 · Recital 52² · Recital 57² · Recital 60 · Recital 63 · Recital 74² · Recital 76² · Recital 78 · Recital 83 · Recital 92 · Recital 98² · Article 2²⁵ · Article 9² · Article 10²⁶ · Article 11¹⁴ · Article 12³ · Article 13¹² · Article 14¹³ · Article 15³ · Article 16⁹ · Article 17⁴ · Article 18³ · Article 19³ · Article 21 · Article 22⁶ · Article 25 · Article 26 · Article 27⁵ · Article 28 · Article 29⁴ · Article 30³ · Article 31⁴ · Article 32³ · Article 33 · Article 36 · Article 44² · Article 45³ · Article 46⁷ · Article 51⁵ · Article 52¹³ · Article 53⁵ · Article 54³ · Article 56⁴ · Article 58³ · Article 60³ · Article 61¹⁷ · Article 62² · Article 71 · Article 83⁴ · Article 85 · Article 86⁵ · Article 87¹⁶ · Article 88³ · Article 89¹⁶ · Article 90 · Article 91² · Article 92⁶ · Article 95 · Article 105 · Article 106⁵ · Article 117² · Article 120 · Article 122² · Annex I³⁷ · Annex II⁶ · Annex III³ · Annex IV² · Annex IX⁵¹ · Annex VI¹⁹ · Annex VII⁷⁶ · Annex VIII² · Annex X¹³ · Annex XI²³ · Annex XII⁵ · Annex XIII⁵ · Annex XIV¹⁰ · Annex XV⁵