MDCG 2020-7_guidance_pmcf_plan_template_en
MDCG 2020-7 上市后临床随访计划模板 PMCF Plan Template.pdf,Ref. Ares(2020)2214397 - 24/04/2020 Medical Device Medical Device Coordination Group Document MDCG 2020-7 MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template A guide for manufacturers
The Medical Device n Group (MDCG) has released the MDCG 2020-7 document。which provides guidance on post-market clinical follow-up plans for medical devices。This document is XXX (IVDR). Post-Market Clinical Follow-Up Plan Template The MDCG 2020-7 document includes a template for post-marke...
a. 目前MDCG已经发布的关于PMPF指南MDCG 2020-7 Guidance on PMCF Plan Template,适用于MDR。 b. 根据MDCG发布的2023年指导文件最新更新时间表,可知预计 Q2 2023将新发布指南Guidance on Post-Market Surveillance requirements,可能涉及IVDR产品的PMPF要求,届时制造商可及时跟进学习。 4. 怎么提交PMPF plan ? 与技...
制造商根据MDR,附录XIV, B部分要求,编制上市后临床跟踪(PMCF)计划和报告,同时可使用 MDCG 2020-7 Post-market clinical follow-up (PMCF)Plan TemplatePMCF 计划模板和 MDCG 2020-8 Post-market clinical follow-up (PMCF)Evaluation Report TemplatePMCF 报告模板。
Guidance Post-market Surveillance PMCF Plan Template (MDCG 2020-7) ec.europa.eu/health/sys Guidance Post-market Surveillance Periodic Safety Update Report (PSUR) according to the MDR (MDCG 2022-21) health.ec.europa.eu/lat Guidance Post-market Surveillance (Vigilance) Q&A on Vigilance terms and...
MDCG 指南清单2022年
内容提示: Medical Device Medical Device Coordination Group Document MDCG 2020-8 1 MDCG 2020-8 Post-market clinical follow-up (PMCF) Evaluation Report Template A guide for manufacturers and notified bodies April 2020 This document has been endorsed by the Medical Device Coordination Group (MDCG) ...
2020May MDCG 2020-10/1 ndix Clinical investigation su 附录 :临床试验总 2020 mmary safety report form 结安全报告表 Guidance on PMCF evaluation PMCF 评价报告模 MDCG 2020-8 April 2020 report template 板的指南 Guidance on PMCF plan temp PMCF 计划模板的 MDCG 2020-7 April 2020 late 指南 ...
内容提示: Medical Device M ed i c a l D e v i c e C oo r d i na t i on G r oup D o c u m en t MDCG 2020-8 1 MDCG 2020-8 上市后临床随访 (PMCF) 评估报告模板 制造商和公告机构指南 April 2020 本文件已通过法规(EU) 2017/745第103条建立的医疗器械协调小组(MDCG)的认可...