Annex XVII

Annex XVII

Reproduced from official EUR-Lex 1/1/2026.

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) 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 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	—

SCOPE AND DEFINITIONS

MAKING AVAILABLE ON THE MARKET AND PUTTING INTO SERVICE OF DEVICES, OBLIGATIONS OF ECONOMIC OPERATORS, REPROCESSING, CE MARKING, FREE MOVEMENT

IDENTIFICATION AND TRACEABILITY OF DEVICES, REGISTRATION OF DEVICES AND OF ECONOMIC OPERATORS, SUMMARY OF SAFETY AND CLINICAL PERFORMANCE, EUROPEAN DATABASE ON MEDICAL DEVICES

NOTIFIED BODIES

CLASSIFICATION AND CONFORMITY ASSESSMENT

CLINICAL EVALUATION AND CLINICAL INVESTIGATIONS

POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE

COOPERATION BETWEEN MEMBER STATES, MEDICAL DEVICE COORDINATION GROUP, EXPERT LABORATORIES, EXPERT PANELS AND DEVICE REGISTERS

CONFIDENTIALITY, DATA PROTECTION, FUNDING AND PENALTIES

FINAL PROVISIONS

Comparing

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