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 regarding the transitional provision under Article 120 o
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 certificates according to MDD or AIMDD March 2020 This document has been endorsed ...
https://ec.europa.eu/health/md_sector/new_regulations/guidance_en 这个网站都是MDCG的指南 ...
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...
MDCG 2020-3 REV 1.0 MDR欧盟关于重大变更指南文件于2023年5月进行了升版。 MDCG 2020-3 REV 1.0 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 ...
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”...
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 ...
ThisguidancedocumentisintendedtosupportsponsorsindevelopingtheirIBbydescribingin greaterdetailwhattypeofinformationisexpectedintherespectiveIBsections,inordertopre- emptquestionsfromthecompetentauthoritiesduringtheassessmentoftheclinicalinvestigation application.TheguidanceisbasedontherequirementsofboththeMDRandISO14155:2020as...
Describe any standards, guidance or other solutions that have been applied, and the manufacturers justification Non-compliances identified and resolved for this section may be briefly described in this box 20 Excluding devices listed in Annex XVI which must comply with the relevant common ...