CHAPTER VI

CLINICAL EVALUATION AND CLINICAL INVESTIGATIONS

Clinical evaluation
Article 61. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

General requirements regarding clinical investigations conducted to demonstrate conformity of devices
Article 62. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Informed consent
Article 63. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Clinical investigations on incapacitated subjects
Article 64. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Clinical investigations on minors
Article 65. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Clinical investigations on pregnant or breastfeeding women
Article 66. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Additional national measures
Article 67. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Clinical investigations in emergency situations
Article 68. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Damage compensation
Article 69. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Application for clinical investigations
Article 70. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Assessment by Member States
Article 71. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Conduct of a clinical investigation
Article 72. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Electronic system on clinical investigations
Article 73. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Clinical investigations regarding devices bearing the CE marking
Article 74. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Substantial modifications to clinical investigations
Article 75. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Corrective measures to be taken by Member States and information exchange between Member States
Article 76. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early termination
Article 77. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Coordinated assessment procedure for clinical investigations
Article 78. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Review of coordinated assessment procedure
Article 79. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Recording and reporting of adverse events that occur during clinical investigations
Article 80. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Implementing acts
Article 81. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Requirements regarding other clinical investigations
Article 82. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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))