規制動向

米国

MDSAPに参加

  • 定期査察の代替としてMDSAP調査結果を受入
  • これまでのrisk-based approach査察からfor causeを中心とした査察への移行を意図

2018年2月、FDAの医療機器に関する品質規則であるQSR(Quality System Regulations)をISO13485へ整合させる意向を表明

  • 医療機器QMS規則の国際ハーモナイゼーションのための取組の一環
  • 企業のコンプライアンスや記録の保持等の負担を減らすこと、およびより多くの医療機器企業の米国への参入を促すことが目的。
  • 現在、ISO13485:2016要求事項を評価し、QSRとの差分を検出するために両要求事項のマッピング作業を実施中
  • 2019年春頃、ISO13485に準拠したQSR改正案を発表予定
EU

2017年5月27日に欧州医療機器規則(Medical Device Regulation 2017 /745: MDR)が発効

  • 医療機器指令(Medical Devices Directive 93/42/EEC: MDD)および能動植込医療機器指令(Active Implantable Medical Devices Directive 90/385/EEC: AIMDD)を統合・代替
  • 移行期間は3年(2020年5月26日まで)

2017年5月27日に欧州体外診断用医療機器規則 (In Vitro Diagnostic Regulation 2017/746:IVDR )が発効

  • IVD Directive (98/79/EC:IVDD) を代替
  • 移行期間は5年(2022年5月26日まで)。移行期間が長い理由は下記:
    • クラス分類の大幅な変更
    • 現在IVDD下で認証を受けている体外診断用医療機器であってもIVDRの下での再認証の取得が必要

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