【翻译】MDCG 2020-6 根据指令93/42/EEC或90/385/EEC获得CE认证的医疗器械所需的临床证据(7) 内个谁 从事医疗器械临床试验多年 1 人赞同了该文章 Appendix III – Suggested hierarchy of clinical evidence for confirmation of conformity with relevant GSPRs under the MDR附录III–在MDR下证明符合相关GSPRs...
and the device is identified as belonging to the group of ‘well-established technologies’ (see section 1.2 and Appendix III in this document) a lower level of clinical evidence may be justified to be sufficient for the confirmation of conformity with...
需要金币:*** 金币(10金币=人民币1元) mdcg_2020-6 关于传统设备的充分临床证据的指导.pdf 关闭预览 想预览更多内容,点击免费在线预览全文 免费在线预览全文 Medical Device Medical Device Coordination Group Document MDCG 2020-6 MDCG 2020-6 Regulation (EU) 2017/745: Clinical evidence needed for medica...
建议申办者在递交Investigator’s Brochure (IB) 之前,填写本指南 Appendix A中的核对表,以确保Investigator’s Brochure (IB)符合MDR Article 70规定的审定申请的最低要求。如果使用核对表,应将核对表与Investigator’s Brochure (IB)一并提交。 在准备Investigator’s Brochure (IB)时,鼓励申办者审查法规的全部细节...
21 Please, for further information on kits, also see IMDRF Unique Device Identification system (UDI system) Application Guide - Appendix G, as endorsed at EU level in MDCG 2021-10 - 'The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices'. Please...
MDCG, MDCG 2020-10/1 Rev 1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745. 2022. MDCG, MDCG 2020-10/2 Rev 1 Guidance on safety reporting in clinical investigations Appendix: Clinical investigation summary safety report form...
characteristics are described in the MEDDEV 2.7/1 rev. 4 Appendix 1 and are aligned with the MDR requirement, there are differences in the criteria that are set out for each of the three characteristics. Differences in criteria between the MDR and the MEDDEV ...
需要金币:*** 金币(10金币=人民币1元) MDCG 2020-5 临床评价指南.pdf 关闭预览 想预览更多内容,点击免费在线预览全文 免费在线预览全文 Medical Device Medical Device Coordination Group Document MDCG 2020-5 MDCG 2020-5 Clinical Evaluation - Equivalence A guide for manufacturers and notified bodies Apri...
was written with respect to the MDD and AIMDD to provide practical guidance on several scientific and clinical aspects that are relevant for conducting clinical evaluation. However only the text of the MDR is authentic in law, sections relevant to the MDR are listed in Appendix I to this ...
6REPORTBYWHOM8 7REPORTTOWHOM8 8REPORTINGTIMELINES8 8.1REPORTBYSPONSORTONCAS8 8.2REPORTBYTHEINVESTIGATORTOTHESPONSOR9 9CAUSALITYASSESSMENT9 10REPORTINGFORM11 10.1COMPLETIONGUIDELINES:FORMHEADER11 10.2COMPLETIONGUIDELINES:EVENTDETAILS13 11REFERENCES16 12APPENDIX–CLINICALINVESTIGATIONSUMMARYSAFETYREPORTINGFORM16 ...