2021年7月12日 2020年3月,欧盟委员会(EC)公布了医疗器械协调小组(MDCG)“MDCG 2020-3 MDR第120条关于MDD或AIMDD证书所涵盖器械的过渡条款的重大变更指南”( MDCG 2020-3 Guidance on significant changes regar…
MDCG 2020-3 重大变更和附件指南.pdf,Medical Device Medical Device Coordination Group Document MDCG 2020 - 3 MDCG 2020-3 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by cer
https://ec.europa.eu/health/md_sector/new_regulations/guidance_en 这个网站都是MDCG的指南 ...
MDCG 2020 - 3 Guidance on significant changes & annexes 关于根据MDD或AIMDD对证书所涵盖的设备进行的MDR第120条下的过渡条款重大变更的指南 2020年3月 本指导文件旨在澄清根据MDR第120(3)条应被视为“设计上的重大更改或预期用途的重大更改”的设备更改。 评估应根据具体情况进行。
Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD March 2020 《医疗器械法规(EU)2017/745(MDR)》第120(2)和120(3)条规定,具有根据《可植入医疗器械有效指令》 90/385 / EEC由指定...
2023年2月6日 2022年5月,欧盟委员会(EC)公布了医疗器械协调小组(MDCG)“MDCG 2022-6 IVDR第110(3)条过渡条款下的重大变更指南”(MDCG 2022-6 Guidance on significant changes regarding the transitional pr…
2022年5月,欧盟委员会(EC)公布了医疗器械协调小组(MDCG)“MDCG 2022-6 IVDR第110(3)条过渡条款下的重大变更指南”(MDCG 2022-6 Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR)。 该指南的目的是澄清IVDR第110(3)条中“设计和预期用途的重大变更”...
ThisguidancedocumentisintendedtosupportsponsorsindevelopingtheirIBbydescribingin greaterdetailwhattypeofinformationisexpectedintherespectiveIBsections,inordertopre- emptquestionsfromthecompetentauthoritiesduringtheassessmentoftheclinicalinvestigation application.TheguidanceisbasedontherequirementsofboththeMDRandISO14155:2020as...
3 Devices which are not placed on the market but put into service may also make use of the transitional provisions . 4 Article 120(4) ‘and may continue to be made available on the market …until 26 May 2025’. 5 Guidance on significant changes under Article 120 of the MDR with ...
MDCG 2020-13 临床评价报告模板.pdf,Medical Devices Medical Devices Coordination Group Document MDCG 2020-13 MDCG 2020-13 Clinical evaluation assessment report template July 2020 This document has been endorsed by the Medical Device Coordination Group (MDC