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Annex XV

Reproduced from official EUR-Lex 10/1/2025.

CORRELATION TABLE

Directive 98/79/EC

This Regulation

Article 1(1)

Article 1(1)

Article 1(2)

Article 2

Article 1(3)

points (54) and (55) of Article 2

Article 1(4)

—

Article 1(5)

Article 5(4) and (5)

Article 1(6)

Article 1(9)

Article 1(7)

Article 1(5)

Article 2

Article 5(1)

Article 3

Article 5(2)

Article 4(1)

Article 21

Article 4(2)

Article 19(1) and (2)

Article 4(3)

Article 19(3)

Article 4(4)

Article 10(10)

Article 4(5)

Article 18(6)

Article 5(1)

Article 8(1)

Article 5(2)

—

Article 5(3)

Article 9

Article 6

—

Article 7

Article 107

Article 8

Articles 89 and 92

Article 9(1) first subparagraph

Article 48(10) first subparagraph

Article 9(1) second subparagraph

Article 48(3) second subparagraph, Article 48(7) second subparagraph and Article 48(9) second subparagraph

Article 9(2)

Article 48(3) to (6)

Article 9(3)

Article 48(3) to (9)

Article 9(4)

Article 5(6)

Article 9(5)

—

Article 9(6)

Article 11(3) and (4)

Article 9(7)

Article 10(7)

Article 9(8)

Article 49(1)

Article 9(9)

Article 49(4)

Article 9(10)

Article 51(2)

Article 9(11)

Article 48(12)

Article 9(12)

Article 54(1)

Article 9(13)

Article 48(2)

Article 10(1) and (2), second sentence of Article 10(3) and Article 10(4)

Articles 26(3), 27 and 28

Article 10(3), first sentence

Article 11(1)

Article 11(1)

Articles 82(1) and 84(2)

Article 11(2)

Article 82(10) and Article 82(11) first subparagraph

Article 11(3)

Article 84(7)

Article 11(4)

—

Article 11(5)

Article 86

Article 12

Article 30

Article 13

Article 93

Article 14(1)(a)

—

Article 14(1)(b)

Article 47(3) and (6)

Article 14(2)

—

Article 14(3)

—

Article 15(1)

Article 38 and Article 39

Article 15(2)

Article 32

Article 15(3)

Article 40(2) and (4)

Article 15(4)

—

Article 15(5)

Article 51(5)

Article 15(6)

Article 51(4)

Article 15(7)

Article 34(2) and Article 40(2)

Article 16

Article 18

Article 17

Articles 89 to 92

Article 18

Article 94

Article 19

Article 102

Article 20

Article 97

Article 21

—

Article 22

—

Article 23

—

Article 24

—

Official catalogue · non-binding

Related guidance (1)

Current English catalogue entries that refer to Annex XV. Guidance is non-binding and kept separate from the regulation text.

Browse topics
MDCG 2019-7 - rev.1Guidance on article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC)December 2023
Non-binding guidanceOpen guidance page
Catalogue section
Person responsible for regulatory compliance (PRRC)
Published
December 2023
Topics

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