医療機器ソフトウェアの開発について

2017年11月25日以降は、プログラム（ソフトウェア）を用いた医療機器の承認または認証の際、申請書添付資料において、JIS T 2304（IEC 62304）への適合を説明しなければならなくなった。
2017 年５月 17 日に発出された『医療機器の基本要件基準第12条第２項の適用について』（薬生機審発 0517 第１号）と呼ばれる課長通知の別添にJIS T 2304への適合の根拠となる文書の記載例が示されている。
IEC 60601などのような安全規格の場合は、試験結果の合否が明確であるのに対して、JIS T 2304（IEC 62304）はプロセス規格であるため、適合したかどうかはほぼ自己宣言の形に近いものとなる。
JIS T 2304（IEC 62304）はウォーターフォールモデルを用いた一般のソフトウェア開発プロセスと大きな差異はない。
異なる点は、アーキテクチャ仕様書において、アイテム分割を行い、アイテム毎にソフトウェア安全性クラス分類を実施することである。
なぜならば医療機器は安全でなければならないためである。
安全性クラス分類においては、JIS T 2304（IEC 62304）では他のリスクコントロール手段（例：ハードウェア）によってリスク低減が可能であれば、リスク低減後の安全性クラスを記載しても良いこととなっている。
一方で、FDAの場合「General Principles of Software Validation」によって、リスクコントロール前のソフトウェアに関するリスクによりLevel of Concernを決定しなければならないので、注意が必要である。

筆者が医療機器スタートアップ企業などでしばしば質問を受けることは、QMS省令とJIS T 2304（IEC 62304）の関連性である。
QMS省令の設計開発は、主にH/Wを中心に要求されている。そのため、ソフトウェア部分に関しては、QMS省令の設計開発の要求ではなく、JIS T 2304（IEC 62304）に従って設計開発を実施する必要がある。
単体プログラム（SaMD：Software as Medical Device）の場合は、JIS T 2304（IEC 62304）にのみ従えば良いこととなる。
スタートアップ企業が、製造販売業許可をとる際には、設計開発以外のQMSも構築しなければならない。
業許可のための立ち入り調査において、QMS省令およびGVP省令への適合性を調査されることとなる。

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