F1CHAPTER VIIPOST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE
F1Section 1Post-market surveillance
F1Article 78Post-market surveillance system of the manufacturer
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F1Article 79Post-market surveillance plan
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F1Article 80Post-market surveillance report
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F1Article 81Periodic safety update report
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F1Section 2Vigilance
F1Article 82Reporting of serious incidents and field safety corrective actions
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F1Article 83Trend reporting
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F1Article 84Analysis of serious incidents and field safety corrective actions
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F1Article 85Analysis of vigilance data
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F1Article 86Implementing acts
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F1Article 87Electronic system on vigilance and post-market surveillance
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F1Section 3Market surveillance
F1Article 88Market surveillance activities
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F1Article 89Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance
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F1Article 90Procedure for dealing with devices presenting an unacceptable risk to health and safety
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F1Article 91Procedure for evaluating national measures at Union level
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F1Article 92Other non-compliance
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F1Article 93Preventive health protection measures
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F1Article 94Good administrative practice
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F1Article 95Electronic system on market surveillance
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Regulation revoked (31.12.2020) by The Medical Devices Regulations 2002 (S.I. 2002/618), reg. 4P (as inserted by S.I. 2019/791, regs. 1(1), 3(7) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 9(m)); 2020 c. 1, Sch. 5 para. 1(1))