『MDRの最新スケジュール』

MDRの最新スケジュールについて

欧州委員会が6月3日付でMDR（Medical Device Regulation：欧州医療機器規則）・IVDR（In Vitro Diagnostic Regulation：欧州体外診断用医療機器規則）に関するRolling Planを公表した。
MDRは新型コロナウィルスのパンデミックの影響で適用開始日が1年延期された。
また、EUにおける医療機器データベースであるEUDAMEDの適用についても、最初に公開される予定であるアクター登録モジュールの公開予定が当初の2020年5月から2021年3月に延期されている。
Rolling Planでは以下を公開している。
・MDR及びIVDRに関する実装行為（Implementing Acts）及びタイムライン並びにステータス
・実装行為（Implementing Acts）以外に実施すべき事項及びタイムライン並びにステータス
実装行為としてリストされた項目には以下のようなものがある：
・単回使用機器の再処理に関する事項
・医療目的でない機器に関する共通仕様
・expert labolatoriesの指定
・IVDRの元でのEU参照laboratoriesに関する指定
・EUDAMEDに関する事項
等
とりわけ、EUDAMEDに関しては、Rolling Planにおいて以下の計画がなされている。
・EUDAMEDの完全稼働：2022年
・ただし、各モジュールは機能するようになった時点で五月雨式に公開予定
・その他Help Deskに関する事項 等

MDRに関するセミナーはこちらをご視聴ください。

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