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Sans CJK SC", "WenQuanYi Micro Hei", sans-serif;">歐盟醫(yī)療器械CE注冊流程</p><p style="margin-top: 1.4em; margin-bottom: 1.4em; padding: 0px; background-color: rgb(255, 255, 255); color: rgb(18, 18, 18); font-size: medium; line-height: 40px; text-wrap: wrap; font-family: -apple-system, Bl<i></i>inkMacSystemFont, "Helvetica Neue", "PingFang SC", "Microsoft YaHei", "Source Han Sans SC", "Noto Sans CJK SC", "WenQuanYi Micro Hei", sans-serif;">1）你首先需要的是得到一個合格的PRRC（負(fù)責(zé)法規(guī)遵從性的人）。通常由同一個人擔(dān)任ISO13485定義的管理者代表。但是，這可以分包給合格的顧問（如CMS）。</p><p style="margin-top: 1.4em; margin-bottom: 1.4em; padding: 0px; background-color: rgb(255, 255, 255); color: rgb(18, 18, 18); font-size: medium; line-height: 40px; text-wrap: wrap; font-family: -apple-system, Bl<i></i>inkMacSystemFont, "Helvetica Neue", "PingFang SC", "Microsoft YaHei", "Source Han Sans SC", "Noto Sans CJK SC", "WenQuanYi Micro Hei", sans-serif;">2）接下來，您需要根據(jù)醫(yī)療器械法規(guī)（MDR）附件VIII對您的器械進(jìn)行分類。</p><p style="margin-top: 1.4em; margin-bottom: 1.4em; padding: 0px; background-color: rgb(255, 255, 255); color: rgb(18, 18, 18); font-size: medium; line-height: 40px; text-wrap: wrap; font-family: -apple-system, Bl<i></i>inkMacSystemFont, "Helvetica Neue", "PingFang SC", "Microsoft YaHei", "Source Han Sans SC", "Noto Sans CJK SC", "WenQuanYi Micro Hei", sans-serif;">3）根據(jù)ISO13485制定了質(zhì)量管理體系（QMS）。如果您是一級自我認(rèn)證產(chǎn)品，則無需獲得認(rèn)證機(jī)構(gòu)（如TUV、BSI、等）的審核。之所以要在編制技術(shù)文檔之前先開發(fā)QMS，是因?yàn)槟梢蚤_始以有序和正式的方式記錄您的規(guī)范、設(shè)計(jì)輸入和輸出。這是為了防止在產(chǎn)品設(shè)計(jì)完成后需要做回顧性文檔。</p><p style="margin-top: 1.4em; margin-bottom: 1.4em; padding: 0px; background-color: rgb(255, 255, 255); color: rgb(18, 18, 18); font-size: medium; line-height: 40px; text-wrap: wrap; font-family: -apple-system, Bl<i></i>inkMacSystemFont, "Helvetica Neue", "PingFang SC", "Microsoft YaHei", "Source Han Sans SC", "Noto Sans CJK SC", "WenQuanYi Micro Hei", sans-serif;">4）根據(jù)MDR附件II和附件III編制技術(shù)文件。格式與舊MDD的基本需求清單略有不同。請注意，在MDR和Meddev2.7.1版本4下，CER不再那么容易通過CE要求。即使是有經(jīng)驗(yàn)的監(jiān)管人員也可能需要尋求有經(jīng)驗(yàn)的臨床作者來為制造商審查或起草CER。</p><p style="margin-top: 1.4em; margin-bottom: 1.4em; padding: 0px; background-color: rgb(255, 255, 255); color: rgb(18, 18, 18); font-size: medium; line-height: 40px; text-wrap: wrap; font-family: -apple-system, Bl<i></i>inkMacSystemFont, "Helvetica Neue", "PingFang SC", "Microsoft YaHei", "Source Han Sans SC", "Noto Sans CJK SC", "WenQuanYi Micro Hei", sans-serif;">歐盟MDD轉(zhuǎn)換為MDR的常見錯誤：</p><ul class=" list-paddingleft-2" style="list-style-type: none;"><li><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; font-size: 1pc; line-height: 40px;">EC DOC中未包含UDI</p></li><li><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; font-size: 1pc; line-height: 40px;">在同一EU MDR DOC中未包含對其他歐盟法規(guī)的引用，例如（藥品，PPE，RoHS）</p></li><li><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; font-size: 1pc; line-height: 40px;">使用相同的MDD一致性路由附件參考，而不是MDR一致性路由附件參考。</p></li><li><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; font-size: 1pc; line-height: 40px;">不確認(rèn)僅提供電子IFU是否符合MDR。</p></li><li><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; font-size: 1pc; line-height: 40px;">完全不遵守附件二的技術(shù)文檔要求</p></li><li><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; font-size: 1pc; line-height: 40px;">臨床評估計(jì)劃缺失</p></li><li><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; font-size: 1pc; line-height: 40px;">缺少PMCF計(jì)劃和報(bào)告或?yàn)楹尾恍枰狿MCF的理由</p></li></ul><p style="margin-top: 1.4em; margin-bottom: 1.4em; padding: 0px; background-color: rgb(255, 255, 255); color: rgb(18, 18, 18); font-size: medium; line-height: 40px; text-wrap: wrap; font-family: -apple-system, Bl<i></i>inkMacSystemFont, "Helvetica Neue", "PingFang SC", "Microsoft YaHei", "Source Han Sans SC", "Noto Sans CJK SC", "WenQuanYi Micro Hei", sans-serif;">另外，記住從GS1這樣的組織獲取您的唯一設(shè)備標(biāo)識符（UDI）。請參閱此處查看UDI實(shí)施時(shí)間表。您還需要選擇合格評定路線。大多數(shù)公司會選擇附件九作為默認(rèn)。同樣，這是不需要的類自我認(rèn)證的產(chǎn)品。</p><p><img src="http://whitemicrobikini.com/skin/b2b/image/lazy.gif" class="lazy" original="http://image.007swz.com/2022/05-17/1830219927.jpg"/></p><p><img src="http://whitemicrobikini.com/skin/b2b/image/lazy.gif" class="lazy" original="http://image.007swz.com/2022/05-18/1332898081.jpg"/></p><p><img src="http://whitemicrobikini.com/skin/b2b/image/lazy.gif" class="lazy" original="http://image.007swz.com/2022/05-24/3205394254.jpg"/></p><p><br/></p><p> </p> </div> </div> <div id="gv0czshfr" class="m"> <div id="gv0czshfr" class="side_head"><div><strong>相關(guān)注冊申請產(chǎn)品</strong></div></div><div id="gv0czshfr" class="side_body"><ul class="relapro"><li><a href="http://whitemicrobikini.com/xinxi/cjiteax.html"><div>醫(yī)療CE歐代注冊申請時(shí)間多久下來</div></a>2023-11-25</li><li><a 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