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。
なぜならば、欧州のCEマーキング制度は自己宣言であるためである。
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。
MDR(欧州医療機器規制)における整合規格
2022年1月4日付で新たに9つの規格が欧州整合規格として認定された。医療機器の生物学的評価、滅菌、無菌処理、品質管理システム、製品情報での記号の使用などの規格である。
これで欧州MDRの下で認定された整合規格は現時点で14規格になった。
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。
整合規格に準拠するメリット
整合規格に準拠するという意味は下記の通りである。
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.
(欧州議会および理事会(2)の規則(EU)2017/745の第8条(1)に従い、関連する整合規格またはそれらの規格の関連部分に準拠している機器、EU官報に掲載されているものは、それらの規格またはその一部がカバーするその規則の要件に準拠していると推定される。)
つまり、整合規格に準拠すれば、MDRの該当する要件を満たしているとpresume(推定)されるというのが整合規格への準拠のメリットである。
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。
関連商品
[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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