{
  "node_id": "eu-medical-devices-regulation-mdr-2017-745-implementation",
  "title": "Regulation (EU) 2017/745 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC",
  "domain": "Pharmaceuticals & Life Sciences",
  "version": "1.0.0",
  "last_updated": "2026-04-21",
  "bluf": "The EU Medical Devices Regulation (MDR) 2017/745 establishes a comprehensive framework for the safety and performance of medical devices in the EU, requiring manufacturers to classify devices (Annex VIII), generate robust clinical…",
  "paywall": {
    "status": "LOCKED",
    "unlock_cost_usd": "0.01",
    "skyfire_id": "41779894-ece2-4163-9761-b3b1b76e19b0"
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  "crosswalks": {
    "_available_keys": [
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    "_note": "Full crosswalk values included in vault response"
  },
  "dependencies": [
    "eu-gmp-annex-1-sterile-manufacture-2022",
    "ich-q10-pharmaceutical-quality-system-2008",
    "fda-21-cfr-part-312-ind-investigational-new-drug",
    "fda-real-world-evidence-program-guidance-2018"
  ],
  "primary_citations_count": 5,
  "workflow_steps_count": 10,
  "schema_fields_count": 10,
  "citation_preview": [
    "Regulation (EU) 2017/745, Article 51 - Rules for classification of devices",
    "Regulation (EU) 2017/745, Annex VIII - Classification rules"
  ]
}