CHAPTER VII

POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE
SECTION 1

Post-market surveillance

Post-market surveillance system of the manufacturer
Article 83. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Post-market surveillance plan
Article 84. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Post-market surveillance report
Article 85. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Periodic safety update report
Article 86. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SECTION 2

Vigilance

Reporting of serious incidents and field safety corrective actions
Article 87. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Trend reporting
Article 88. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Analysis of serious incidents and field safety corrective actions
Article 89. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Analysis of vigilance data
Article 90. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Implementing acts
Article 91. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Electronic system on vigilance and on post-market surveillance
Article 92. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SECTION 3

Market surveillance

Market surveillance activities
Article 93. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance
Article 94. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Procedure for dealing with devices presenting an unacceptable risk to health and safety
Article 95. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Procedure for evaluating national measures at Union level
Article 96. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Other non-compliance
Article 97. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Preventive health protection measures
Article 98. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Good administrative practice
Article 99. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Electronic system on market surveillance
Article 100. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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))