コロナ禍により、本来今年の5/26から完全施行される予定であったMDR（Medical Device Regulation）が1年延期となった。
欧州に製品を輸出している多くの医療機器企業はホッとしたのではないだろうか。
そもそもMDDがMDRになったきっかけは、いわゆる”PIPスキャンダル”である。
フランスのPIP社が製造した豊胸用バッグの破裂率が非常に高く、またコストを下げるために人体用シリコンではなく工業用シリコンを使用していた。
そのため、インプラント手術を受けた女性の体内でバックが破裂し、また生体適合性の問題で癌になったとされる症例（死亡例を含む）も発生した。
当然のことながらPIP社とその経営者は刑事罰を受けることとなったが、当該製品を認証したNBまでもが罰金刑（有罪）となってしまったのである。
ところがである。問題はそれでは済まない。実はPIP社の製品がインプラントされた女性のうち16万人もの人がトレースできない状況なのである。
つまり埋め込み型医療機器において、トレーサビリティが不完全であったためである。
このPIPスキャンダルは、いわば欧州医療機器規制の重大な汚点となった。
この事件をきっかけに約20年も続いたMDDがMDRへと移行されることが決定され、世界で最も厳しい規制要件となった。
MDRにおいては埋込み型医療機器はインプラントカードの発行が必須となる。
また米国同様UDI規制が導入され、全クラスのトレーサビリティの確立が求められることとなった。
さらにUDIは電子データベースに登録が義務付けられ、ビジランスシステムと融合して、事故報告などをリンクするような仕組みとなっている。
医薬品の規制において、欧州のビジランスシステム（ファーマコビジランス）は世界で最も厳しい規制であるが、これと同様の規制が医療機器でも要求されることになった訳である。
ビジランスシステムとは、製品の不具合により患者へ健康被害を及ぼすような事象を当局 に報告する手順である。
不具合事象の報告と、製品のFSCA（Field Safety Corrective Action ＝ 市場での安全に関わる是正処置）の手順を文書化することが要求される。
更に、市場投入後の製品に関する情報収集を通して当該医療機器の改良や今後の製品開発へのフィードバックが行えるような体制の構築が必要になる。
製造業者の品質システムにおいて、機器の特性による故障や異常に関する情報が入り、それによって死亡および重大な健康被害を与える恐れがある場合、製造業者はFSCAを開始しなけらばならない。
また、前述の通り、ビジランスのデータはUDIデータベースに登録することになる。
MDRが日米の規制と異なる点は、法定代理人（欧州代理人）が対応しなければならないことである。米国代理人はほとんど責任がなく、当局報告も実施しないが、欧州代理人はそれと異なる。
またサプライチェーンの事業者全体がMDRを遵守しなければならない。製造業者、輸入業者、販売業者などである。
MDRの施行が1年延びたことは幸運である。できるだけ早く法定代理人、輸入業者、販売業者を巻き込んだシステム（手順書）の構築が望まれる。
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