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EU MDR
Dynamic EU MDR 2017/745 Full Text
Chapter 1 (Art 1 - 4) Scope and definitions
Chapter 2 (Art 5 - 24) – Making available on the market and putting into service of devices, obligations of economic operators, reprocessing, CE marking, free movement
Chapter 3 (Art 25 - 34) – Identification and traceability of devices, registration of devices and of economic operators, summary of safety and clinical performance, European database on medical devices
Chapter 4 (Art 35 - 50) – Notified bodies
Chapter 5 (Art. 51 – 60) Classification and conformity assessment
Chapter 6 (Art. 61 – 82) Clinical evaluation and clinical investigations
Chapter 7 (Art. 83 – 100) Post-market surveillance, vigilance and market surveillance
Chapter 8 (Art. 101 – 108) Cooperation between member states, medical device coordination group, expert laboratories, expert panels and device registers
Chapter 9 (Art. 109 – 113) Confidentiality, data protection, funding and penalties
Chapter 10 (Art. 114 – 123) Final provisions
Annexes
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Annexes
Annex 17 – Correlation table
Council Directive 90/385/EEC
Council Directive 93/42/EEC
This Regulation
Article 1(1)
Article 1(1)
Article 1(1)
Article 1(2)
Article 1(2)
Article 2
Article 1(3)
Article 1(3) first subparagraph
Article 1(9)
first subparagraph
Article 1(3)
Article 1(3) first subparagraph
Article 1(9)
first subparagraph
—
Article 1(3) second subparagraph
Article 1(9)
second subparagraph
Article 1(4) and (4a)
Article 1(4) and (4a)
Article 1(8)
first subparagraph
Article 1(5)
Article 1(7)
Article 1(11)
Article 1(6)
Article 1(5)
Article 1(6)
—
Article 1(6)
—
—
Article 1(8)
Article 1(13)
—
Article 1(8)
Article 1(13)
Article 2
Article 2
Article 5(1)
Article 3 first paragraph
Article 3 first paragraph
Article 5(2)
Article 3 second paragraph
Article 3 second paragraph
Article 1(12)
Article 4(1)
Article 4(1)
Article 24
Article 4(2)
Article 4(2)
Article 21(1) and (2)
Article 4(3)
Article 4(3)
Article 21(3)
Article 4(4)
Article 4(4)
Article 10(11)
Article 4(5)(a)
Article 4(5) first subparagraph
Article 20(6)
Article 4(5)(b)
Article 4(5) second subparagraph
—
Article 5(1)
Article 5(1)
Article 8(1)
Article 5(2)
Article 5(2)
Article 8(2)
Article 6(1)
Articles 5(3) and 6
—
Article 6(2)
Article 7(1)
Article 114
Article 7
Article 8
Articles 94
to
97
—
Article 9
Article 51
Article 8(1)
Article 10(1)
Articles 87(1)
and
89 (2)
Article 8(2)
Article 10(2)
Article 87(10)
and
Article 87(11)
first subparagraph
Article 8(3)
Article 10(3)
Article 89(7)
Article 8(4)
Article 10(4)
Article 91
Article 9(1)
Article 11(1)
Article 52(3)
—
Article 11(2)
Article 52(6)
—
Article 11(3)
Article 52(4)
and
(5)
—
Article 11(4)
—
—
Article 11(5)
Article 52(7)
Article 9(2)
Article 11 (6)
Article 52(8)
Article 9(3)
Article 11(8)
Article 11(3)
Article 9(4)
Article 11(12)
Article 52(12)
Article 9(5)
Article 11(7)
—
Article 9(6)
Article 11(9)
Article 53(1)
Article 9(7)
Article 11(10)
Article 53(4)
Article 9(8)
Article 11(11)
Article 56(2)
Article 9(9)
Article 11(13)
Article 59
Article 9(10)
Article 11(14)
Article 4(5)
and
Article 122
third paragraph
—
Article 12
Article 22
—
Article 12a
Article 17
Article 9a(1) first indent
Article 13(1)(c)
—
Article 9a(1) second indent
Article 13(1)(d)
Article 4(1)
—
Article 13(1)(a)
Article 51(3)(a)
and
Article 51(6)
—
Article 13(1)(b)
Article 51(3)(b)
and
Article 51(6)
Article 10
Article 15
Articles 62
to
82
Article 10a(1), second sentence of Article 10a(2) and Article 10a(3)
Article 14(1), second sentence of Article 14(2) and Article 14(3)
Articles 29(4)
,
30
and
31
Article 10a(2), first sentence
Article 14(2) first sentence
Article 11(1)
Article 10b
Article 14a
Articles 33
and
34
Article 10c
Article 14b
Article 98
Article 11(1)
Article 16(1)
Articles 42
and
43
Article 11(2)
Article 16(2)
Article 36
Article 11(3)
Article 16(3)
Article 46(4)
Article 11(4)
Article 16(4)
—
Article 11(5)
Article 16(5)
Article 56(5)
Article 11(6)
Article 16(6)
Article 56(4)
Article 11(7)
Article 16(7)
Articles 38(2)
and
44(2)
Article 12
Article 17
Article 20
Article 13
Article 18
Articles 94
to
97
Article 14
Article 19
Article 99
Article 15
Article 20
Article 109
Article 15a
Article 20a
Article 102
Article 16
Article 22
—
Article 17
Article 23
—
—
Article 21
—
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