ISO 13485の認証取得は必須か

ISO 13485の認証取得は必須か

筆者はしばしば医療機器のスタートアップ企業などから、ISO 13485の認証取得の支援コンサルテーションを依頼される。
しかしである。ISO 13485の認証取得は必ずしも必須ではない。
日本の場合、QMS省令に適合してQMSを構築・運用していれば良く、米国の場合は21 CFR Part 820 QSRなどに準拠してQMSを構築・運用していれば良い。
また、実は欧州においてもISO 13485の認証取得は必須ではないのである。
ISO 13485を遵守して医療機器の設計・製造を実施している旨を適合宣言書として自己宣言すれば良いのである。


これにより、EN ISO 13485:2016も、やっとMDRの整合規格となったのである。



In accordance with Article 8(1) of Regulation (EU) 2017/745 of the European Parliament and of the Council (2), devices that are in conformity with the relevant harmonised standards, or the relevant parts of those standards, the references of which have been published in the Official Journal of the European Union, are to be presumed to be in conformity with the requirements of that Regulation covered by those standards or parts thereof.

本邦においても、ISO 13485の認証を取得していれば、品目申請時の実地調査が軽減されることがあり、ISO 13485の認証を取得するメリットはある。


[blogcard url=”” title=”QMS(手順書)ひな形 医療機器関連” ]

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