イーコンプライアンス CEマーキング制度情報
*万が一文中に解釈の間違い等がありましても、当社では責任をとりかねます。
本文書の改訂は予告なく行われることがあります。
CEマークは、医療機器、電気製品、通信機器、産業機械など、製品分野ごとに21種類の指令が定められている。
それぞれの分野に該当する指令の要求事項を満たした製品がCEマークを貼付でき、EU域内での販売が認められる。
医療機器への指令は「欧州埋込型能動医用機器指令︓ AIMD(90/385/EEC)」「欧州医療機器指令︓ MDD(93/42/EEC)」「欧州体外診断医療機器指令︓ IVDD (98/79/EC)」が該当する。
現行の指令でも、欧州で医療機器を販売するためには、当局から認可を受けた認証機関による審査を通過することにより、CEマークを自己責任として貼付することが必要である。CEマークなしでは欧州で医療機器を販売することはできない。
医療機器に関するCEマークのための審査が現行指令から新規制に変更となる。
MDR(欧州医療機器規制)はCEマーク表示を得るための新しい規制である。
MDRに準拠できなければCEマークを取得できず、欧州市場で医療機器を販売できなくなる。
CEマークは、医療機器のEU健康安全環境保護指令・規制順守を示す重要な指標である。
CEマークは、EU加盟国に加え、アイスランド、リヒテンシュタイン、ノルウェー、スイス、トルコにて適応されており、アジア太平洋領域の主要国でもCEマークを適用している。
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