2021年7月15日に、MDCGガイダンスMDCG 2021-19 「Guidance note integration of the UDI within an organisation’s quality management system」が発出されました。
本ガイダンス文書の翻訳はこちらをご覧ください。(株式会社オフィスヴィレッジのサイトに遷移します。)
当該ガイダンスはUDIシステムの実装に当たり、組織の品質マネジメントシステムに以下に組み込んでいくかについて解説したものです。
UDIの施行期限は以下のように規定されています:
![](http://xn--2lwu4a.jp/wp-content/uploads/2021/07/image.png)
![](http://xn--2lwu4a.jp/wp-content/uploads/2021/07/image-1.png)
施行期限までに、UDIを適切に実施するための仕組みを品質マネジメントシステムに組み込む必要があります。
本ガイダンス文書の翻訳はこちらをご覧ください。(株式会社オフィスヴィレッジのサイトに遷移します。)
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