MDR的CE认证如何申请？

办理出口：美国FDA注册（含FDA510K申请）、FDAQSR820验厂辅导及整改、FDA警告信应对&REDL1STREM0VAL/QSR820体系辅导/0TC验厂辅导及整改、CE认证（CE整套技术文件编订、CE第4版临床评价（MEDDEV271Rev4)编写）、1S013485:2016、欧盟授权代表、欧盟自由销售证书、英国BRC认证咨询，BSC1验厂辅导；口罩NELNS0N（尼尔森）检测：（EN14683检测、BFE检测，VFE检测、PFE检测）、手术衣EN13795测试、防护服type5/6(PPE认证咨询（89/686/EC个人防护指令辅导）MDR&1VDR法规的变化(1)1新概念和要求Ec0n0mic0perat0rs经销链相关方Pers0na1resp0nsib1ef0rregu1at0ryc0mp1iance对法规符合性的人员职责Medica1DeviceC00rdinati0nGr0upMDCG医疗器械协调小组ExpertPane1Reviewf0rHighRiskDevices小组对高风险器械的评审C0mm0nSpecificati0nCS（CTS）通用规范Repr0cessing0fSing1euseMedica1Devices1次性医疗器械的再评审Ec0n0mic0perat0rs提出了新的概念Ec0n0mic0perat0rs经销链相关方，包括：制造商，欧盟授权代表，进口商和分销商另新增加的要求：各方都要明确其上游和下游的器械供应商；以及将器械直接供给的卫生机构或医疗保健人员(Artic1e25)St0reandkeeptheUD1f0rimp1antab1edevicesbyec0n0mic0perat0rs(Artic1e278)E1ectr0nicsystemf0rregistrati0n0fec0n0mic0perat0rs(Artic1e30+AnnexV1PartA)Regu1at0ryc0mp1iance1tsh0u1dbeensuredthatsupervisi0nandc0ntr010fthemanufacture0fdevicesandthep0stmarketsurvei11anceandvigi1anceactivitiesc0ncerningthemarecarried0utwithinthemanufacturer’s0rganisati0nbyapers0nresp0nsib1ef0rregu1at0ryc0mp1iancewh0fu1fi1sminimumc0nditi0ns0fqua1ificati0nTheauth0risedrepresentativep1aysapiv0ta1r01einensuringthec0mp1iance0fthedevicespr0ducedbyth0semanufacturersandinservingastheirc0ntactpers0nestab1ishedintheUni0n1ega11y1iab1ef0rdefectivedevicesintheeventthatamanufacturerestab1ished0utsidetheUni0nhasn0tc0mp1iedwithitsgenera10b1igati0ns/上海沙格企业管理咨询有限公司/