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REF-MDR-EU

Field Value
Title Regulation (EU) 2017/745 on medical devices (MDR)
Type eu_reg
URL https://eur-lex.europa.eu/eli/reg/2017/745/oj
Notes EU lifecycle and market-placement requirements for medical devices.
Linked rules 1

Rules Using This Reference

Rule Pack Severity Title
MED-001 F_OVERLAY critical Must meet EU MDR requirements for placing devices on market + safety/performance

Sources

  • D:\02_Code\36_RapidDraft_DFMBenchmark_ExpertMode\server\dfm\manifest.json
  • D:\02_Code\36_RapidDraft_DFMBenchmark_ExpertMode\server\dfm\rule_library.json
  • D:\02_Code\36_RapidDraft_DFMBenchmark_ExpertMode\server\dfm\references.json
  • D:\02_Code\36_RapidDraft_DFMBenchmark_ExpertMode\server\dfm\process_classifier.json
  • D:\02_Code\36_RapidDraft_DFMBenchmark_ExpertMode\server\dfm\overlays.json
  • D:\02_Code\36_RapidDraft_DFMBenchmark_ExpertMode\server\dfm\roles.json
  • D:\02_Code\36_RapidDraft_DFMBenchmark_ExpertMode\server\dfm\report_templates.json
  • D:\02_Code\36_RapidDraft_DFMBenchmark_ExpertMode\server\dfm\ui_bindings.json