{"id":2657,"date":"2020-04-15T03:07:58","date_gmt":"2020-04-15T00:07:58","guid":{"rendered":"https:\/\/www.eurocert-eqc.com\/?page_id=2657"},"modified":"2023-05-20T03:30:05","modified_gmt":"2023-05-20T00:30:05","slug":"medical-devices-eu-2017-745-ce-mark-mdr","status":"publish","type":"page","link":"https:\/\/www.eurocert-eqc.com\/en\/certification\/ce-certification\/medical-devices-eu-2017-745-ce-mark-mdr\/","title":{"rendered":"Medical Devices (EU) 2017\/745 – CE Mark MDR"},"content":{"rendered":"

(EU) 2017\/745 – CE Certification for Medical Devices<\/h3>\n

After more than four years of negotiations at European level, Regulation (EU) 2017\/745 on medical devices came into force on May 25, 2017. With a few exceptions, the regulation will apply from May 26, 2020 and will replace the two medical device directives 90\/385 \/ EEC and 93\/42 \/ EEC.<\/p>\n

    \n
  • Significant innovations in MDR (EU) 2017\/745 include:<\/li>\n
  • Specification of the requirements for the creation and maintenance of the technical documentation for the medical devices,<\/li>\n
  • Tightening of the requirements for clinical evaluation,<\/li>\n
  • Introduction of a new group of reusable surgical instruments, which are intended for reprocessing,Introduction of an additional control<\/li>\n
  • procedure for high-risk medical devices by a panel of experts (so-called Scrutiny procedure),<\/li>\n
  • Tightening of the provisions on post-market surveillance of medical devices and the vigilance system,<\/li>\n
  • Regulation of the reprocessing of single-use products including the prohibition of the reprocessing of certain single-use products,Improving the<\/li>\n
  • identification and traceability of products by introducing a unique product identification number (UDI),Obligation of the manufacturer to provide coverage in the event of liability,<\/li>\n
  • Extension of transparency through the European database (EUDAMED), some of which is publicly accessible,
    \nNew classification rules for software, products with nanomaterials and material medical products, among others<\/li>\n<\/ul>\n<\/div><\/div><\/div>
      \n
    • <\/li>\n<\/ul>\n

      “CE mark for medical devices MDR – As of May 26, 2020, the Medical Device Regulation MDR (EU 2017\/745) will replace the previously applicable Medical Device Directive MDD (93\/42 \/ EEC).”<\/span><\/p>\n<\/div><\/div><\/div><\/div>

      <\/span><\/div>
      <\/div>
      <\/span><\/div>
      <\/div><\/div><\/div><\/div><\/div>
        \n
      • <\/li>\n<\/ul>\n

        “CE mark for medical devices MDR – As of May 26, 2020, the Medical Device Regulation MDR (EU 2017\/745) will replace the previously applicable Medical Device Directive MDD (93\/42 \/ EEC).”<\/span><\/p>\n<\/div><\/div><\/div><\/div>

        <\/span><\/div>
        <\/div>
        <\/span><\/div>
        <\/div><\/div><\/div>

        (EU) 2017\/745 – CE Certification for Medical Devices<\/h3>\n

        After more than four years of negotiations at European level, Regulation (EU) 2017\/745 on medical devices came into force on May 25, 2017. With a few exceptions, the regulation will apply from May 26, 2020 and will replace the two medical device directives 90\/385 \/ EEC and 93\/42 \/ EEC.<\/p>\n

          \n
        • Significant innovations in MDR (EU) 2017\/745 include:<\/li>\n
        • Specification of the requirements for the creation and maintenance of the technical documentation for the medical devices,<\/li>\n
        • Tightening of the requirements for clinical evaluation,<\/li>\n
        • Introduction of a new group of reusable surgical instruments, which are intended for reprocessing,Introduction of an additional control<\/li>\n
        • procedure for high-risk medical devices by a panel of experts (so-called Scrutiny procedure),<\/li>\n
        • Tightening of the provisions on post-market surveillance of medical devices and the vigilance system,<\/li>\n
        • Regulation of the reprocessing of single-use products including the prohibition of the reprocessing of certain single-use products,Improving the<\/li>\n
        • identification and traceability of products by introducing a unique product identification number (UDI),Obligation of the manufacturer to provide coverage in the event of liability,<\/li>\n
        • Extension of transparency through the European database (EUDAMED), some of which is publicly accessible,
          \nNew classification rules for software, products with nanomaterials and material medical products, among others<\/li>\n<\/ul>\n<\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":2110,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"100-width.php","meta":{"footnotes":""},"class_list":["post-2657","page","type-page","status-publish","hentry"],"yoast_head":"\nMedical Devices (EU) 2017\/745 - CE Mark MDR - EQC EN \/\/ Made in Germany<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.eurocert-eqc.com\/en\/certification\/ce-certification\/medical-devices-eu-2017-745-ce-mark-mdr\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medical Devices (EU) 2017\/745 - 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