欧州医療機器規則(MDR: Medical Device Regulation)では、欧州における現行医療機器規制である医療機器指令(MDD: Medical Device Directive)に比べて、様々な要求事項が厳格化されています。


■MDRにおける主要な改正事項 (欧州委員会ウェブサイトより)

  • stricter ex-ante control for high-risk devices via a new pre-market scrutiny mechanism with the involvement of a pool of experts at EU level
    → 高リスク機器の管理強化
  • the reinforcement of the criteria for designation and processes for oversight of Notified Bodies
  • the inclusion of certain aesthetic devices which present the same characteristics and risk profile as analogous medical devices under the scope of these Regulations
    → 医療目的を持たない美容機器等への規制
  • the introduction of a new risk classification system for in vitro diagnostic medical devices in line with international guidance
    → IVDのクラス分類ルールの見直し(国際整合)
  • improved transparency through the establishment of a comprehensive EU database on medical devices and of a device traceability system based on Unique Device Identification
  • the introduction of an “implant card” containing information about implanted medical devices for a patient
    → 埋込医療機器の管理強化
  • the reinforcement of the rules on clinical evidence, including an EU-wide coordinated procedure for authorisation of multi-centre clinical investigations
  • the strengthening of post-market surveillance requirements for manufacturers
  • improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance
    → ビジランスや市場監視における加盟国間の連携強化