臨床評価の重要性

臨床評価の重要性

ISO 13485 7.3.7『設計・開発のバリデーション』に以下の要求がある。
『設計・開発のバリデーションの一部として、組織は、適用される規制要求事項に従い、医療機器の臨床評価または性能評価を実施する。』
医療機器においては『臨床評価』の実施が必須であり、体外診断用医薬品においては『性能評価』が必須である。

なぜ臨床評価が重要か？

そもそも医療機器はヒトに対して使用するものであり、臨床評価により安全性および有効性を評価することは当然である。
臨床評価は、医療機器の安全性と性能が、十分な臨床的エビデンスに基づいて、市場における機器のライフサイクルを通して継続的に評価されていることを保証するために重要である。

なぜ継続的な臨床評価が必要か？

MDR（欧州医療機器規制）において、PMCF（市販後の臨床フォローアップ）に関する要求が厳しくなった。
MDRにおいて、PMCF計画書などは技術文書の一つとして数えられ、適切に作成・維持および遵守が求められる。
多くの医療機器企業において、PMCFを実施しないと決定していることが見受けられる。
しかしである。医療機器の設計・開発において、残留リスクが受容可能ではなく、リスク/ベネフィット比を根拠に開発を推進するケースがある。
しかしながら、医療機器の設計・開発時に想定されたリスク/ベネフィット比は、時間の経過とともに変化することを忘れてはならない。
なぜならば、医療機器の製造販売後において、
・ベネフィット（有効性）は下がるのみ。
・リスクは上がるのみ。（新たなハザードの発見）
だからである。

つまり、当該医療機器の設計・開発当時よりも、より良い治療・診断技術が発明され、または医薬品などの開発により代替されることもある。これにより、ベネフィットは下がってしまうのである。
一方において、リスクが下がることはまず考えられず、むしろ設計・開発時に想定していなかった新たなハザードが発見されることがある。つまり、当該医療機器の設計・開発当時よりもリスクは高くなってしまうのである。

最新のリスク/ベネフィット比を知るには、臨床的知見の蓄積は必須である。またState of the art（最先端）も変化するため、最新の安全性情報（類似品など）、規制要件、国際規格、共通仕様などを取り込まなければならない。

継続的な臨床評価プロセスにより、製造業者が機器のライフサイクルを通じて常に機器のリスク/ベネフィット比を評価し、必要に応じて機器を改良する必要性があるのである。
今後、新規医療機器を開発するにあたって、よほどリスクマネジメントが完全・完璧でない限りはPMCFに実施は必須となるであろう。

Image

【IEC-62304対応】規程・手順書ひな形販売開始

（サンプルはこちら ［規程］・［手順書］）

本邦において、2017年11月より、IEC 62304（医療機器ソフトウェア ‐ ソフトウェアライフサイクルプロセス）が、実質的な規制要件となりました。
IEC 62304は、2006年5月に発行され、日本では2012年にJIS化（JIS T 2304）されました。
米国FDAにおいても、2008年7月にRecognized Consensus Standardと認定されています。

IEC 62304は「医療機器ソフトウェア」の開発と保守に関するプロセスを規定しています。 
日本以外でも、欧州・北米・中国などにおいて、医療機器申請時にIEC 62304に基づくソフトウェア開発の証拠が必要です。 
つまり、IEC 62304に従って、「医療機器ソフトウェア」を開発しなければ、国内外においてソフトウェアを搭載した医療機器（単体プログラムを含む）を販売することができません。 しかしながら、 IEC 62304は非常に難解です。具体的に、どのような対応をとればよいのでしょうか。

一般にIEC 62304のようなプロセス規格は各社によってまちまちの解釈が行われ、手順書の内容が大きく異なってしまいます。 
・IEC 62304を読んでも、対応すべき内容や方法が分からない。
・IEC 62304を読んでも、どこまでやるべきなのかの範囲が分からない。 
・IEC 62304の詳細の内容が、不明なまま文書構築を行っている。
などといった疑問点が多く寄せられます。 

本「IEC 62304対応規程・手順書ひな形」を導入いただくことによってIEC 62304に準拠したQMSを効率的・効果的に作成することができます。

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