官方：这些CE认证无效（附认证机构名单）

admin · 发表于 2020-10-14 12:29:35

                  <section data-role="paragraph" data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section><p><p><img src="image/20201014/86b79d371e9862b01189f0252a03b2cd_1.png" /></p></p></section><section><section><span><strong></strong></span></section><p><span>医疗器械媒体报道先锋</span></p><p><span>分享专业医疗器械知识</span></p></section><section><section><section><span>关注</span></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><p><br  /></p><p><span><span>来源：</span><span>赛柏蓝器械</span></span></p><section><section><section><section><section><section><br  /></section></section></section></section></section></section><p><span><strong><span>1、两类CE认证无效</span></strong></span></p><p><br  /></p><p><span>根据上海市监局官微4月14日消息，近日上海市监局发现一些个人和组织以牟利为目的，通过网络平台、短信等方式发布“可快速办理CE认证”等信息。</span></p><p><br  /></p><p><span>这些个人和组织</span><span><strong>通过诱导企业委托其代理实际无效或者没有必要的所谓“CE认证证书”，并以此收取高额费用</strong></span><span>，不仅使企业蒙受经济损失，更严重扰乱了认证市场秩序。</span></p><p><br  /></p><p><span>针对医用口罩和个人防护口罩，以下两类文件并不是CE认证证书。</span></p><p><br  /></p><p><span>第一类针对医用口罩（非无菌）（Disposable medical protective mask (not sterile)），</span><span><strong>相关证明文件上标示“CE文件审核（CE Documentation Review）”，这类文件不是认证证书。</strong></span></p><p><br  /></p><p><span><p><img src="image/20201014/662ac351e642c84b94093ef4afcf9049_2.png" /></p></span></p><p><br  /></p><p><span>第二类针对个人防护口罩(Disposable daily productive mask)，</span><strong><span>相关证明文件上标示“符合性证书（Certificate of Compliance）”或类似字样，但颁发该证书的机构并不是欧盟的公告机构，或者虽然是公告机构，但授权范围不包括PPE法规。</span></strong></p><p><br  /></p><p><span><p><img src="image/20201014/269c2ad78fb827c627e207db62397af3_3.png" /></p></span></p><p><br  /></p><p><span>上海市监局还表示，近期市场上出现大量以ENTE CERTIFICAZIONE MACCHINE SRL公司名义向国内口罩生产企业颁发的针对口罩类产品（个人防护口罩及医用口罩（非无菌））的证明文件。</span></p><p><br  /></p><p><span>文件上均标注该公司的“ECM”标志及CE标志。经查明，ENTE CERTIFICAZIONE MACCHINE SRL在（EU）2016/425（PPE）领域并非获得授权的公告机构，不能对个人防护口罩进行CE认证。</span></p><p><br  /></p><p><span><strong><span>2、CE认证机构名单，国家市监局公布</span></strong></span></p><p><br  /></p><p><span>近期国家市监局发布《口罩等防疫用品出口欧盟及美国市场认证信息指南》表示，对口罩出口欧盟提供信息指南。</span></p><p><br  /></p><p><span>指南显示，欧盟根据用途将口罩分为两类：医用口罩和个人防护口罩。</span></p><p><br  /></p><p><span><strong><span>医用口罩：</span></strong></span><span>医用口罩需按照欧盟医疗器械指令93/42/EEC（MDD）或欧盟医疗器械条例EU2017/745（MDR）加贴CE标志，对应的标准是EN14683。根据口罩产品无菌或非无菌状态，采取的合格评定模式也不同。</span></p><p><br  /></p><p><span>（1）无菌医用口罩：必须由授权公告机构进行CE认证。</span></p><p><span>（2）非无菌医用口罩：企业只需进行CE自我符合性声明，不需要通过公告机构认证。在准备好相应文件及测试报告等资料后，即可自行完成符合性声明。</span></p><p><br  /></p><p><span><strong><span>个人防护口罩：</span></strong></span><span>个人防护口罩不属于医疗器械，但需符合欧盟个人防护设备条例EU2016/425（PPE）要求，由授权公告机构进行CE认证并颁发证书，对应的标准是EN149。</span></p><p><br  /></p><p><span>同时，国家市监局还公布了中国境内具有口罩等防疫用品CE认证能力的认证机构名录，以及可以开展医疗器械管理体系（ISO13485）认证的机构名录，具体如下：</span></p><p><br  /></p><section><span><strong><span>中国境内具有口罩等防疫用品CE认证能力的认证机构名录：</span></strong></span></section><section><br  /></section><p><p><img src="image/20201014/f242341429f060c92d5e0b8682ad7b7e_4.png" /></p></p><p><br  /></p><section><span><strong><span>中国境内可以开展医疗器械管理体系（ISO13485）认证的机构名录：<br  /></span></strong></span></section><section><br  /></section><section><span><strong><p><img src="image/20201014/262010f8c172be4a82313167e8dd8c61_5.jpg" /></p></strong></span></section><section><br  /></section><section data-role="outer" label="Powered by gulangu"><section data-role="paragraph" data-color="#757576"><section data-role="paragraph"><section><section><section 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