CHAPTER V

CLASSIFICATION AND CONFORMITY ASSESSMENT
SECTION 1

Classification

Classification of devices
Article 51. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SECTION 2

Conformity assessment

Conformity assessment procedures
Article 52. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Involvement of notified bodies in conformity assessment procedures
Article 53. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Clinical evaluation consultation procedure for certain class III and class IIb devices
Article 54. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Mechanism for scrutiny of conformity assessments of certain class III and class IIb devices
Article 55. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Certificates of conformity
Article 56. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Electronic system on notified bodies and on certificates of conformity
Article 57. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Voluntary change of notified body
Article 58. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Derogation from the conformity assessment procedures
Article 59. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Certificate of free sale
Article 60. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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))