{
  "node_id": "eu-medical-devices-regulation-2017-745-mdr-conformity-assessment",
  "title": "EU Medical Devices Regulation 2017/745 (MDR) - Conformity Assessment and CE Marking",
  "domain": "Medical & Healthcare",
  "version": "1.0.0",
  "last_updated": "2024-05-26",
  "bluf": "Regulation (EU) 2017/745 (MDR) replaced Directive 93/42/EEC from May 2021, establishing enhanced conformity assessment requirements for medical devices placed on the EU market. Higher-risk devices (Class IIa, IIb, Class III, implantables) require involvement of a Notified Body for CE marking. Manufacturers must implement a Quality Management System (ISO 13485), conduct clinical evaluations, establish post-market surveillance, and register in EUDAMED. Unique Device Identification (UDI) is mandatory for all classes.",
  "paywall": {
    "status": "LOCKED",
    "unlock_cost_usd": "0.01",
    "skyfire_id": "41779894-ece2-4163-9761-b3b1b76e19b0"
  },
  "crosswalks": {
    "_available_keys": [
      "industry_mapping",
      "use_cases",
      "related_standards",
      "geographic_scope",
      "compliance_timeline"
    ],
    "_note": "Full crosswalk values included in vault response"
  },
  "dependencies": [
    "iso-13485-2016-medical-devices-quality-management",
    "iso-14971-medical-risk"
  ],
  "primary_citations_count": 5
}