Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance)
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| 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 | — |
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