MEDICAL DEVICES

IN VITRO DIAGNOSTIC MEDICAL DEVICES

Annex XV: 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 Article 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), Article 10(3) second sentence and Article 10(4) Article 26(3), Article 27 and 28
Article 10(3) first sentence Article 11(1)
Article 11(1) Articles 82(1) and Article 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 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 Article 89 to 92
Article 18 Article 94
Article 19 Article 102
Article 20 Article 97
Article 21
Article 22
Article 23
Article 24