2020年11月2日 2020年4月,欧盟委员会(EC)公布了医疗器械协调小组(MDCG) MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template 和MDCG 2020-8 Post-market clinical follow-up (PMCF) Evaluation R…
Group Document MDCG 2020-7 Introduction The Medical Device Regulation (EU) 2017/745 (MDR) considers the post-market clinical follow-up (PMCF) as a continuous process that updates the clinical evaluation and that shall be addressed in the manufacturer’s post-market surveillance (PMS) plan. The...
Article 79规定了PMS Plan应作为技术文件的一部分,与技术文件一起提交给公告机构。 PMS report 要点 A类和B类IVD产品的制造商应准备一份PMS report,总结根据PMS Plan收集的上市后监督数据的分析结果和结论,以及所采取的任何预防和纠正措施的理由和描述。报告应在必要时予以更新,并应要求提供给公告机构和主管当局。 P...
MDCG 2020-7_guidance_pmcf_plan_template_en
TheMedicalDeviceRegulation(EU)2017/745(MDR)considersthepost-marketclinicalfollow-up(PMCF)asacontinuousprocessthat updates the clinical evaluation and that shall be addressed in the manufacturer’s post-market surveillance (PMS) plan. The MDR reinforcesthePMCFprocessbythemanufacturer,devotingpartBofAnnexXIV...
updates the clinical evaluation and that shall be addressed in the manufacturer’s post-market surveillance (PMS) plan. The MDR reinforces the PMCF process by the manufacturer, devoting part B of Annex XIV to it and providing a set of requirements for developing ...
If the device is a system of several components/devices, each device in the system should have a Basic UDI-DI but also one Basic UDI-DI for the system. It is the Basic UDI-DI for the system that is intended to be provided in section 1.4 in the template, and that will be associated...
《医疗器械规例》(欧盟)2017/745 (MDR)认为,上市后临床随访(PMCF)是一个不断更新临床评估的过程,应在制造商的上市后监督(PMS)计划中予以处理。MDR加强了制造商的PMCF流程,将附件十四的B部分纳入其中,并提供了一套制定实施PMCF所需计划的要求。 A PMCF plan shall specify the methods and procedures set up by...
the PMCF process is an essential part of the manufacturer’s PMS plan。and it aims to ensure the ongoing safety and performance of medical devices XXX implementing a PMCF plan。which should be XXX the latest clinical data and emerging risks。By following the PMCF requirements。manufacturers XXX....
PMS, PMCF and the plan for updates 20 Section G: IFU, SSCP, labelling and other information supplied with the device 21 Overall Conclusions: 24 Specific Considerations 25 Section I: Clinical evaluation consultation procedure for certain class III and class IIb devices (Article 54) 25 Section J:...