21 CFR Part 803 MDR

Part 803 MEDICAL DEVICE REPORTING とは
  • FDAの医療機器の有害事象報告制度に関する規則
  • 21 CFR Part803の下で、製造業者、ユーザ施設、輸入業者は特定の医療機器に関する有害事象をFDAに報告する義務を負う
  • 21CFR Part803の邦訳はこちら
Part 803　MEDICAL DEVICE REPORTING　目次
  • Subpart A–通則
    • § 803.1 -本Partは、何をカバーするか？
    • § 803.3 -本Part で使用された用語は、FDAではどのように定義されているか？
    • § 803.9 -報告の中のどのような情報を公衆に公開しなければならないか？
    • § 803.10 -一般的に、私にどのような報告要求事項が適用されるか？
    • § 803.11 -個別の副作用報告は、どのようなフォームで提出しなければならないか？
      そのフォームは何処で入手できるか？
    • § 803.12 -報告、および追加の情報は、何処に、どのように報告するか？
    • § 803.13 -報告は、英語でしなければならないか？
    • § 803.15 -医療機器報告に関して追加情報の要求がある場合、どのように知らされるか？
    • § 803.16 -報告を提出する場合、報告中の情報は、医療機器が報告すべき事例の原因または報告すべき事例に寄与したものであることを容認したことになるか？
    • § 803.17 -文書化されたMDR手順の確立、維持、および実施に関して、私に適用される要求事項は何か？
    • § 803.18 -MDRのファイルの確立、および維持、または記録に関して、私に適用されるか要求事項は何か？
    • § 803.19 – 有害事象報告に関する要求事項に除外、特例、または代替手段はあるか？
  • Subpart B–個別有害事象報告に関して一般的に適用される要求事項
    • § 803.20 -個別の有害事象報告は、どのように完成し、提出するか？
    • § 803.21 -医療機器報告を使用して有害事象報告を行うための報告コードは、どこにあるか？?
    • § 803.22 -どのような状況の場合、私は、報告をファイルすることを要求されないか？
    • § 803.23 – MDRを電子的なフォーマットで作成する方法についての情報はどこにあるか？
    • § 803.20 -個別の有害事象報告は、どのように完成し、提出するか？
    • § 803.21 -医療機器報告を使用して有害事象報告を行うための報告コードは、どこにあるか？?
    • § 803.22 -どのような状況の場合、私は、報告をファイルすることを要求されないか？
    • § 803.23 – MDRを電子的なフォーマットで作成する方法についての情報はどこにあるか？
  • Subpart C– ユーザファシリティに対する報告要求事項
    • § 803.30 -ユーザファシリティである場合、私にはどのような報告要求事項が適用されるか？
    • § 803.32 -ユーザファシリティである場合、個別の有害事象報告には、どのような情報を提出しなければならないか？
    • § 803.33 -ユーザファシリティである場合、年次報告には、どのような事項を含め、何時提出しなければならないか？
  • Subpart D–輸入業者に対する報告要求事項
    • § 803.40 -輸入業者である場合、どのような個別の有害事象報告を、何時、誰に提出しなければならないか？
    • § 803.42 -輸入業者である場合、個別の有害事象報告には、どのような情報を提出しなければならないか？
  • Subpart E–製造業者に対する報告要求事項
    • § 803.50 -製造業者である場合、どのような報告要求事項が適用されるか？
    • § 803.52 -製造業者である場合、個別の有害事象報告では、どのような情報を提出しなければならないか？?
    • § 803.53 -製造業者である場合、どのような場合に5日報告を提出しなければならないか？
    • § 803.56 -製造業者である場合、どのような場合に補足、またはフォローアップ報告を提出しなければならないか？そしてこれらの報告の要求事項は何か？
    • § 803.58 -国外製造業者
MDRに関する製造業者の義務
  • 死亡、重大な障害および機能不全に関する初回報告の30暦日以内の提出（part803.50）
  • 5労働日以内の5日報告の提出（part803.53）
  • 新規または変更情報を入手した場合の30暦日以内の追加報告の提出（part803.56）
  • MDR手順の確立（part803.17）
  • MDRイベントファイルの確立・維持（part803.18）
  • 事象の原因を究明するための調査（part803.50(b)）
  • 各事象に関する完全な調査の実施（part820.198）
  • 事象に関し、以下を含む合理的に知った全ての情報のFDAへの提供 （part803.52）
    • 報告者に連絡を取ることで得た情報
    • 製造業者が持つあらゆる情報　または
    • 分析、試験、その他評価等によって得られたあらゆる情報
ＵＤＩ規制の目的
  • 流通・使用の間に機器を適切に特定できるシステムの確立
    • 迅速かつ正確な機器の特定を容易にする
    • 機器に関する重要な情報へのアクセスを可能にする
    • 電子的なヘルスレコード、クリニカルインフォメーションシステム、レセプトデータソースおよびレジストリに機器の使用を文書化するための 標準的でかつ明確な方法を提供する
製造業者のMDR報告義務についての一般的規定（803.10）
  • 報告すべき死亡、重大な障害または機能不全について認識（become aware）した日から30日以内の報告（30日報告）
  • 個々の有害事象について以下の事項を認識（become aware）した日から5日以内の報告（5日報告）：
    • 公衆衛生への重大な危害を引き起こす不当なリスクを防ぐために緊急措置が必要である報告すべき事象
    • FDAが文書によるリクエストを行った報告すべき事象
  • 最初の報告で報告することができなかった事項についての補足レポート
製造業者のMDR報告義務の規定
  • 30日報告（803.50）
    • 市販している機器に関して合理的に以下に掲げる事項の情報を、あらゆる情報源から受け取ったか、もしくは認識した（become aware）日から30暦日以内にFDAに報告しなければならない：
      • 死亡または重大な障害を引き起こした、または寄与した可能性（caused or contributed）がある
      • 当該機器または類似の機器が機能不全（malfunction）を抱えており、その機能不全が再発した場合、死亡や重大な事象を引き起こす可能性がある
  • 5日報告（803.53）
    • 下記の事象を認識した（become aware）日から5労働日以内に要求される情報を含めた5日報告をFDAに提出しなければならない：
      • 公衆衛生への潜在的な危害の不当なリスクを防ぐために改善措置が必要とするMDR報告すべき事象を認識した時。
      • FDAが文書によるリクエストで5日報告の提出を求めた場合。
引き起こした、または寄与した（caused or contributed）とは
  • 死亡または重大な障害が医療機器によって引き起こされたまたはその可能性がある 　
    または
  • 以下を含む事象の結果として、医療機器が死亡または重大な障害の要素となったまたはその可能性がある：
    • 故障
    • 機能不全
    • 不適切な設計
    • 製造の問題
    • ラベリングの問題
    • ユーザエラー
重大な障害とは
  • 重大な障害とは以下の障害または病気のことをいう：
    • 生命を脅かす
    • 身体機能に恒久的な障害をもたらす、または身体構造に恒久的なダメージを与える
    • 身体機能への恒久的な障害または身体構造への恒久的なダメージを除去するために医療的または外科的な介入を必要とする
      • 恒久的とは不可逆的な身体構造または機能への障害またはダメージのことをいい、ささいな機能障害またはダメージを除く
機器の機能不全を報告すべき場合
  • 機器が仕様を満たさないまたは意図されたとおりに動作しない
    および
  • 当該機能不全が再発した場合、機器が死亡または重大な障害を引き起こすまたは寄与しうる
「認識した」（become aware）とは
  • 次の場合、企業はある事象を認識（become aware）している：
    • 従業員が30日報告で報告されるべき事象またはFDAが要求した5日報告をすべき事象を合理的に示す情報を認識した場合
    • 規制や科学または技術に関する責任（コンサルタントや契約業者を含む）または有害事象の報告の責任を持つ者に関するマネジメントまたは監督責任をもつ従業員が（傾向分析を含む）あらゆる情報源から公衆衛生への重大な危害を引き起こす不当なリスクを防ぐために緊急措置が必要である報告すべき事象を認識した場合
報告の種類
海外（アメリカ国外）事象についてのMDR
  • アメリカ国外で有害事象が起こった場合の報告義務は以下のテーブルによる：
報告方法
  • Form FDA 3500Aを使用し、電子的にFDAへ報告（eMDR）
MDR手順書 （part803.17）
  • 製造業者/輸入業者はMDR手順を確立し、以下を確実にしなければならない
    • MDRとなり得るイベントのタイムリーで効果的な識別、情報伝達および評価
    • 報告基準へ該当するかどうかを決定するための標準化されたレビュプロセス/手順
    • 完全な報告のタイムリーな伝達
  • MDR手順において、以下の文書化および記録の維持について定めなければならない
    • 当該事象が報告すべきものかどうかを決定するために評価したあらゆる情報
    • 提出されたすべての医療機器報告および情報
    • FDAによるタイムリーなフォローアップおよび査察を容易にする情報へのアクセスを確実にするシステム
MDRイベントファイル（part803.18）
  • 製造業者はMDRイベントファイルを確立、維持しなければならない。
  • ファイルは紙/電子どちらの形式でも良く、その他の情報（患者情報、医療機器情報等）を引用しうる
  • ファイルには以下を含めなければならない：
    • 当該事象に関して製造業者が有するまたは参照する情報
    • 死亡、重大な障害または機能不全が報告すべき事象であったかどうかの意思決定プロセスの文書化
    • FDAへ提出したMDRの写し
    • eMDRの提出に対するレスポンスとしてFDAが送信したすべての電子的なアクノリッジメント
    • 必要な情報をFDAへ提出しなかった/できなかった理由の説明
    • 各事象に関する評価結果
  • MDRイベントファイルは次のうちどちらか長い方の期間維持しなければならない
    • ファイルに記録を含めた日から2年間
    • 機器の予想耐用年数の間
受託製造業者に関する免除リクエスト
  • Specification developerのために製品を製造し、自らは販売・流通を行わない受託製造業者（contract manufacturer）はPart803.50の報告義務を負わない（specification developerは報告義務を負う）
  • 受託製造業者が販売・流通を行う場合には、Specification developerおよび受託業者の双方がMDR報告義務を負う
  • Specification developerまたは受託製造業者のどちらか一方のみに報告義務を負わせたい場合、803.19(b)に従い、FDAに免除リクエストをする必要がある

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