MDCG 2019-5 EUDAMEDへのレガシー機器の登録

2019年4月にMDCGガイダンス「MDCG 2019-5 Registration of legacy devices in EUDAMED」が発出されました。

当該ガイダンス文書は、2021年5月26日のMDR適用日以降もMDD認証書の下でEU市場に出荷される機器(=レガシー機器)に関する情報のEUDAMEDへの登録について説明するものです。

当該ガイダンスの参考和訳は以下をご覧ください。

「MDCG 2019-5 EUDAMEDへのレガシー機器の登録 参考和訳」

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[blogcard url=https://xn--2lwu4a.jp/qms-md/ title=”QMS(手順書)ひな形 医療機器関連” ]

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