ANNEXES
ANNEX II

TECHNICAL DOCUMENTATION
The technical documentation and, if applicable, the summary thereof to be drawn up by the manufacturer shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements listed in this Annex.
1.

DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS AND ACCESSORIES
1.1.

Device description and specification
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.

Reference to previous and similar generations of the device
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.

INFORMATION TO BE SUPPLIED BY THE MANUFACTURER
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.

DESIGN AND MANUFACTURING INFORMATION
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.

GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.

BENEFIT-RISK ANALYSIS AND RISK MANAGEMENT
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.

PRODUCT VERIFICATION AND VALIDATION
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Regulation revoked (31.12.2020) by The Medical Devices Regulations 2002 (S.I. 2002/618), reg. 4O (with savings and transitional provisions for N.I. in reg. 3ZA) (as amended by S.I. 2019/791, regs. 1(1), 3(7) and by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2; and as amended (27.7.2021) by The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 4, 32); 2020 c. 1, Sch. 5 para. 1(1))