CHAPTER IV

NOTIFIED BODIES

Authorities responsible for notified bodies
Article 35. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Requirements relating to notified bodies
Article 36. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Subsidiaries and subcontracting
Article 37. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Application by conformity assessment bodies for designation
Article 38. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Assessment of the application
Article 39. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Nomination of experts for joint assessment of applications for notification
Article 40. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Language requirements
Article 41. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Designation and notification procedure
Article 42. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Identification number and list of notified bodies
Article 43. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Monitoring and re-assessment of notified bodies
Article 44. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Review of notified body assessment of technical documentation and clinical evaluation documentation
Article 45. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Changes to designations and notifications
Article 46. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Challenge to the competence of notified bodies
Article 47. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Peer review and exchange of experience between authorities responsible for notified bodies
Article 48. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Coordination of notified bodies
Article 49. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

List of standard fees
Article 50. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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))