由于EMDN主要用于支持MDR和IVDR要求的监管目的,因此它在MDR/IVDR器械文件和技术文件、由公告机构进行的技术文件采样 (sampling of technical documentation)、上市后监督 (PMS)、警戒和上市后数据分析(vigilance and post-market data analysis)中也发挥着关键作用。它旨在支持所
2019年12月,欧盟委员会(EC)公布了医疗器械协调小组(MDCG)“MDCG 2019-13关于评估MDR IIa类/ IIb类和IVDR B类/ C类器械的采样指南”( MDCG 2019-13 Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation)。该指南...
sampling of device MDCG 2019-1 用于技术文档评估的器械取样 s for the assessment of the tech December 2019 3 指南 nical documentation Designating authoritys final asse MDCG 2019-1 公告机构的最终评估表格 关键 ssment form Key information (E October 2019 2 资料(EN) N) Application of transitional...
sampling of devices for the December translations of the assessment of the technical documentation 2019 preceding link••• MDCG 2019-12Search for available Designating authoritys final assessment form: Key October translations of the information (EN) 2019 preceding link••• MDCG 2019-10...
mdcg_2022-2_en体外诊断医疗器械(IVD)临床证据的一般原则指南.pdf,Medical Devices Medical Device Coordination Group Document MDCG 2022-2 MDCG 2022-2 Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs) January
Clinical investigations and related documentation 18 Section F: 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 ...
on-site audit (which may be performed remotely in the current context) and regular surveillance audits at least annually. In addition, the notified body will assess the technical documentation and the clinical evaluation of the products ...
3Ifapplicable,themanufacturermaytakeintoaccount‘MDCG2019-13GuidanceonsamplingofMDRClassIIa/ ClassIIbandIVDRClassB/ClassCdevicesfortheassessmentofthetechnicaldocumentation’,whichelaborates ontheterm‘genericdevicegroup’inthatcontext. Page3of10 MedicalDevices ...