ISO 13485の認証取得・遵守は必須か

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。日米欧においてはISO 13485の認証取得は必須ではない。
ただし、国によってはISO 13485等の認証取得を医療機器承認申請の条件としている場合があるので、注意が必要である。

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。
本邦においては、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(または免除)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。

欧州においてもISO 13485の認証取得は必須ではない。
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。
EN 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。(ただし、多くの医療機器は第三者認証機関の認証が必要である。)

各国における国際規格の取り扱い

本邦においては、ISO/IEC等の国際規格は、JISに取り込まれた後に省令や基本要件基準に採用される。
2021年に改正されたQMS省令は、JIS Q 13485:2018に基づくものである。

米国においてはそもそもISOに対する認証は官民ともに関心が薄い。
ただし、FDAがConsensus Standard(認知規格)としてISO/IECを指定することがある。
FDAは現在、QSRをISO 13485に整合させ、QMSR(Quality Management System Regulation)として改定することを発表している。
しかしながら、FDAはこれまでISO 13485をConsensus Standardとして認めて来なかった歴史がある。

欧州においては、ISO/IECは、日本におけるJIS規格と同様にEN ISO/IEC(EN規格)に取り込まれる。
ENとはEuropean Normのことである。Normはノルマのことで達成すべき基準のことである。
一般に国際規格は各国で本文や付属資料を改訂することは許されていない。
EN規格には国際規格に関するEU独自の付属書であるAnnex Zsが付随することがある。
Annex Zsには、規格要求事項への適合が、MDR等の規制要求事項への適合となるか否かを明示した情報や、規格要求事項とMDR等の規制要求事項の差分が示される場合もある。
EU MDR遵守の上では、EN規格のAnnex Zsの確認が非常に重要である。

MDR(欧州医療機器規制)における整合規格とは

MDRでは、欧州整合規格(機器が整合規格に準拠して採択した国家規格)またはCommon Specification(CS:共通仕様)に適合しているならば、安全性と性能の要求事項(GSPR)に適合しているとみなされる。
GSPRを満たすことを示す上で、もし適用可能な欧州整合規格またはCSがある場合は、それを使用することがほぼ必須である。
適用可能な欧州整合規格があるかどうかは、欧州整合規格のリストにより、製造業者として調査する必要がある。
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、EN ISO 13485:2016がMDRの整合規格となった。実にMDR施行後5年経ってからのことである。
なお、欧州MDRの下で認定された整合規格は2022年6月時点で16規格である。

整合規格に準拠するメリット

欧州整合規格への準拠は「Voluntary」とされている。
欧州整合規格に準拠することのベネフィットは「関連する法的要件への適合が推定(presumption)される」ことである。
製造業者は、欧州整合規格以外の規格(整合規格化されていないEUの規格、その他の国際規格等)を自主的に選択することも可能である。
ただし、適用可能な欧州整合規格があるにもかかわらず、他の方法でGSPRへの適合性を証明(法規へのコンプライアンスを証明)する場合は、少なくとも、該当の欧州整合規格の内容を調査した上でそれと同等以上の安全性を保証していることをエビデンスに基づいて説明できることが求められる。

https://www.youtube.com/watch?v=JT0kjBlUSP4

関連商品

[blogcard url=”https://ecompliance.co.jp/SHOP/O083.html” title=”【VOD】欧州医療機器規則(MDR)対応手順書作成セミナー【MDR対応手順書サンプル配布】” content=”MDR(Medical Device Regulation:欧州医療機器規則)は2021年5月26日から完全施行されました。

日本の企業はMDRの全貌を適切に理解しておらず、対応が後手に回っていると思われます。
MDRは、FDAや日本の規制要件、および医薬品の規制要件などを参考に構築されており、いわば世界一厳しい医療機器規制要件となりました。
Manufacturer は、MDRの要求に従ってQMSを適切に改訂しなければなりません。
しかしながらMDRは条文が難解で非常にわかりにくいのが難点です。

いったいどのようなQMSを作成したら良いのでしょうか?

本セミナーでは、MDR対応QMSのサンプルを配布し、MDR対応QMSの構築方法を分かりやすく解説します。”]

[blogcard url=”https://ecompliance.co.jp/SHOP/EL-103.html” title=”【セミナービデオ】欧州医療機器規則(MDR)対応手順書作成セミナー【MDR対応手順書サンプル配布】” content=”MDR(Medical Device Regulation:欧州医療機器規則)は2021年5月26日から完全施行されました。

日本の企業はMDRの全貌を適切に理解しておらず、対応が後手に回っていると思われます。
MDRは、FDAや日本の規制要件、および医薬品の規制要件などを参考に構築されており、いわば世界一厳しい医療機器規制要件となりました。
Manufacturer は、MDRの要求に従ってQMSを適切に改訂しなければなりません。
しかしながらMDRは条文が難解で非常にわかりにくいのが難点です。

いったいどのようなQMSを作成したら良いのでしょうか?

本セミナーでは、MDR対応QMSのサンプルを配布し、MDR対応QMSの構築方法を分かりやすく解説します。”]

[blogcard url=”https://ecompliance.co.jp/SHOP/MD-QMS-168.html” title=”【MDR対応QMSひな形】欧州指定代理人用手順書” content=”CEマーキングを貼付し、欧州に医療機器を輸出している医療機器企業は、MDDに置き換わって2021年5月25日までに欧州医療機器規則(MDR:Medical Device Regulation)に対応する必要があります。
製造業者(Manufacturer)は、この移行期間中に技術文書を改訂し、新しい要求事項に対応しなければなりません。

MDRは、従来のMDDと能動埋め込み型医療機器指令 Active Implantable Medical Device Directive (90/385/EEC)を統合し置き換えるものです。
MDDからMDRへの改正内容は多岐に渡り、また上市済の製品の対策も必要となるため、強制化に間に合うように計画的に対策を進める必要があります。

MDRは、日本や米国の法規制を参考にして作成され、世界で最も厳しい規制となりました。
しかしながらMDRは条文が難解で非常にわかりにくいのが難点です。
本邦におけるQMS省令や米国FDAのQSRにはない要求事項も含まれます。
そのため、多くのQMSに対して加筆修正が発生し、また追加で作成しなければならないQMSもあります。

本MDR対応QMSひな形を使用することで、より短時間で品質良くMDRに対応したQMSを構築することが出来ます。

納品形式:MS-Word”]

[blogcard url=”https://ecompliance.co.jp/SHOP/MD-QMS-169.html” title=”【MDR対応QMSひな形】サプライチェーン管理手順書” content=”CEマーキングを貼付し、欧州に医療機器を輸出している医療機器企業は、MDDに置き換わって2021年5月25日までに欧州医療機器規則(MDR:Medical Device Regulation)に対応する必要があります。
製造業者(Manufacturer)は、この移行期間中に技術文書を改訂し、新しい要求事項に対応しなければなりません。

MDRは、従来のMDDと能動埋め込み型医療機器指令 Active Implantable Medical Device Directive (90/385/EEC)を統合し置き換えるものです。
MDDからMDRへの改正内容は多岐に渡り、また上市済の製品の対策も必要となるため、強制化に間に合うように計画的に対策を進める必要があります。

MDRは、日本や米国の法規制を参考にして作成され、世界で最も厳しい規制となりました。
しかしながらMDRは条文が難解で非常にわかりにくいのが難点です。
本邦におけるQMS省令や米国FDAのQSRにはない要求事項も含まれます。
そのため、多くのQMSに対して加筆修正が発生し、また追加で作成しなければならないQMSもあります。

本MDR対応QMSひな形を使用することで、より短時間で品質良くMDRに対応したQMSを構築することが出来ます。

納品形式:MS-Word”]

[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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