MDR (EU) 2017/745 · Annex I · Technical Documentation

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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 [#1]. The system is built on the harmonised standard EN ISO 14971:2019; the risk management plan defines the acceptability criteria and risk control measures [#2].

Data from post-market surveillance is fed back continuously into risk management; residual risks are weighed in the benefit-risk analysis [#3].

Source documents

MDR (EU) 2017/745 — Annex I, Chapter I, Section 3.1 · mdr-pdf_c0844_fce03621
EN ISO 14971:2019 — risk management for medical devices · mdr-pdf_c0847_a19b2d55
MDR (EU) 2017/745 — Article 10(2) and Annex III, post-market surveillance · std-csv_r0112_7c4e8801

3 sources cited content outside sources: none