IVDR自测制品出口欧盟，需符合这些监管需求！
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">1、</span>体外诊断自测<span style="color: black;">制品</span>的定义</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">Self-testing自测，<span style="color: black;">指的是</span>制造商预期用于非专业人士的医疗器械，<span style="color: black;">包含</span><span style="color: black;">经过</span>社会信息服务向非专业人员<span style="color: black;">供给</span>测试服务的医疗器械。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">2、</span>体外诊断自测<span style="color: black;">制品</span>的欧盟监管<span style="color: black;">需求</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">1.标签和说明书</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">IVDR法规第10条<span style="color: black;">需求</span>，制造商有义务为自测用器械<span style="color: black;">供给</span>易于理解的标签和说明书，且<span style="color: black;">运用</span>成员国指定的欧盟官方语言。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">制造商应<span style="color: black;">根据</span>IVDR法规附录I第20条的<span style="color: black;">需求</span><span style="color: black;">供给</span>标签和说明书，还应<span style="color: black;">根据</span>EN ISO18113-1、EN ISO 18113-4、EN ISO18113-5等标准编制自测器械的标签和说明书。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">1.1说明书</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">自测<span style="color: black;">制品</span>说明书应<span style="color: black;">供给</span>器械预期用途，让<span style="color: black;">运用</span>者<span style="color: black;">认识</span>医疗背景以及能够正确理解检测结果。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">说明书还应<span style="color: black;">供给</span>测试限制、<span style="color: black;">显现</span>非预期测试结果时应采取的<span style="color: black;">办法</span>、可能影响检测结果的<span style="color: black;">行径</span>或信息、<span style="color: black;">运用</span>者<span style="color: black;">是不是</span><span style="color: black;">必须</span>培训或<span style="color: black;">必须</span>具备的资格等。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">1.2标 签</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">标签<span style="color: black;">必须</span>注明自测用途、<span style="color: black;">运用</span>的样本类型、测试过程中<span style="color: black;">必须</span>的其他材料、获取<span style="color: black;">意见</span>和<span style="color: black;">帮忙</span>的联系方式。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">标签<span style="color: black;">运用</span>的图标应符合EN ISO15223-1标准。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="//q2.itc.cn/images01/20240802/28d4cd28dfd447d18f26b69435515704.jpeg" style="width: 50%; margin-bottom: 20px;"></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">2.符合性<span style="color: black;">评定</span>流程</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">自测<span style="color: black;">制品</span>需要<span style="color: black;">经过</span>公告<span style="color: black;">公司</span>审核，审核<span style="color: black;">经过</span>后获颁证书。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">制造商可<span style="color: black;">选取</span>IVDR法规附录IX的符合性<span style="color: black;">评定</span>流程，<span style="color: black;">亦</span>可<span style="color: black;">选取</span>附录X结合附录XI的符合性<span style="color: black;">评定</span>流程。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">2.1附录IX的符合性<span style="color: black;">评定</span>流程，将对制造商质量体系进行审核，以及对所申报<span style="color: black;">制品</span>的技术文档进行<span style="color: black;">评定</span>。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">技术文档应<span style="color: black;">包括</span>：对预期<span style="color: black;">运用</span>者的测试报告、自测<span style="color: black;">制品</span>满足其预期用途的数据，必要时需<span style="color: black;">供给</span><span style="color: black;">制品</span>样品、标签和说明书应<span style="color: black;">供给</span>的内容。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">2.2附录X结合附录XI的符合性<span style="color: black;">评定</span>流程，则采用以生产为重点的质量管理体系进行<span style="color: black;">评定</span>。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">重视</span>：无论<span style="color: black;">选取</span>哪种符合性<span style="color: black;">评定</span>流程，技术文档都应当<span style="color: black;">根据</span>附件II和附件III编制。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">3.EUDAMED数据库</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">按照</span>IVDR法规附录VI，自测<span style="color: black;">制品</span>在EUDAMED数据库中注册时，需<span style="color: black;">知道</span>为自测用途。</p>
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<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="//q1.itc.cn/q_70/images01/20240730/f67311175d564e678158584dda35a486.jpeg" style="width: 50%; margin-bottom: 20px;"><a style="color: black;"><span style="color: black;">返回<span style="color: black;">外链论坛：www.fok120.com</span>，查看<span style="color: black;">更加多</span></span></a></p>
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