MDR (EU) 2017/745 · Annex I · General Safety and Performance Requirements (GSPR)
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MDR Annex I, Chapter I, Section 3 requires the manufacturer to establish, document and maintain a risk management system across the device's whole life cycle . The system is built on the harmonised standard EN ISO 14971:2019; the risk management plan defines the acceptability criteria and risk control measures .
Data from post-market surveillance is fed back continuously into risk management; residual risks are weighed in the benefit-risk analysis .