欧州におけるUDI規制
MDCG(Medical Device Coordination Group)は、2021年7月にガイダンス文書「Guidance note integration of the UDI within an organisation’s quality management system(MDCG 2021-19 )」を発出した。
参考邦訳はこちら
本ガイダンス文書は、製造業者がUDIシステムをそのQMSに取り入れる上での考慮事項について解説するものである。
MDR第10条(9)(h)およびIVDR第10条(8)(h)は「機器に割り当てられたUDIの確認およびEUDAMEDに登録された情報の一貫性および妥当性の保証」を製造業者等の品質マネジメントシステム(QMS)に組み入れ、対応しなければならない旨規定している。
本ガイダンス文書は製造業者等が上記の義務を果たすためのガイダンスを提供することを目的としている。
UDI(UDI-DI+UDI-PI)および基本UDI-DIの割り当て、ならびにUDI関連情報の管理は、他の多くのライフサイクルQMSプロセスに影響を与える可能性がある。
UDIシステムに関する規制への準拠を確実にするための正しい評価/決定が行われ、適切な文書化された証拠が作成されるようにするための手段として、製造業者はUDI実装のための計画を確立し、QMSで規定した適切な手段を用いることができる。
本ガイダンス文書では、QMSにUDIの義務を取り入れる上で検討すべき事項として、以下に関する説明を提供している。
- 設計開発
- 製品の文書および保持
- 製造
- 重大なインシデントおよび市場安全性是正措置
- 購買管理
- 文書化および記録
- ERP
- EUDAMEDデータベースへのUDIデータの提供
また、付属書(Annex)において、QMSにUDIの実装に係るプロセスを取り入れるための具体的な考慮事項や、UDI実施計画の例が示されている。
―目次―
Introduction(導入)
Integration of UDI in the Quality Management System 品質マネジメントシステムへのUDIの組み込み
Design and Development 設計および開発
Product documentation and retention 製品の文書および保持
Production and process 製造およびプロセス
Serious incidents and field safety corrective actions 重大なインシデントおよび市場安全性是正措置
Purchasing controls 購買管理
Documentation and records 文書化および記録
Enterprise Resource Planning エンタープライズリソースプランニング
UDI data to be provided to EUDAMED database EUDAMEDデータベースに提供されるUDIデータ
Appendix I – QMS process implementing UDI at the manufacturer’s site 製造業者のサイトでUDIを実装するQMSプロセス
Plan for product traceability 製品のトレーサビリティの計画
UDI assignment process UDIの割り当てプロセス
Placing UDI Carrier and direct marking UDIキャリアの配置とダイレクトマーキング
UDI linkage to applicable quality records 該当する品質記録へのUDIのリンク
UDI information in EUDAMED EUDAMEDにおけるUDIの情報
Appendix II – Example of a UDI implementation plan UDI実施計画の例
Auditing the implementation of the UDI system UDIシステムの実装の監査
関連商品
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