内容提示: Medical Devices 医疗器械 Medical Device Coordination Group Document MDCG 2022 – 5 医疗仪器统筹小组文件 mdcg2022-5 MDCG 2022 – 5 MDCG 2022-5 Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices 根据《2017/745 医疗...
MDCG Provides Roadmap for MDR Device Transition An updated guidance from the Medical Device Coordination Group (MDCG) explains the modifications that can be made to devices certified under the legacy regulatory system without rendering the device ineligible for the EU market. ...
MedicalDevices MedicalDeviceCoordinationGroupDocumentMDCG2021-5Rev.1 Guidanceonstandardisationformedicaldevices Introduction:scopeandcontents Thisdocumentaimstoprovideguidanceondifferentaspectsrelatedtostandardsinthemedical devicessectorinsupportoftherequirementslaiddownintheapplicableEUlegislation,taking ...
2024年4月,欧盟委员会(EC)公布了医疗器械协调小组(MDCG)“MDCG 2024-5 关于医疗器械临床研究的研究者手册内容的指南”( MDCG 2024-5 guidance on content of the Investigator’s Brochure for clinical investigations of medical devices)。根据第 2017/745 号法规(欧盟 MDR)第 70(1)条,Investigator’s Broch...
They correspond, to a large extent, to the classification rules established by the International Medical Device Regulators Forum (IMDRF) in the guidance document GHTF/SG1/N77:20121. 2 Practical relevance of classification The purpose of this chapter is to provide a general overview on the impact ...
of objective evidence. Section 9.3.1 of MEDDEV 2.7/1 rev. 4 provides guidance for the evaluation of methodological quality and scientific validity under the MDD/AIMDD which are equally valid under the MDR which can be considered to apply when referencing ‘scientific validity’ in this guidance....
They correspond, to a large extent,to the classification rules establishedby the International Medical Device Regulators 1 Forum (IMDRF) in theguidancedocument GHTF/SG1/N77:2012 . 欧盟医疗器械立法对正在使用的医疗器械的分类是一个基于风险的系统,考虑到人体的脆弱 性和与器械相关的潜在风险。这种方法使用...
2022年12月16日,欧盟医疗器械协调小组发布了第21份指南,MDCG 2022-21 GUIDANCE ON PERIODIC SAFETY UPDATE REPORT (PSUR) ACCORDING TO REGULATION (E... 指南 MDCG 文章 MDCG更新欧盟医疗器械边界和分类手册2.0版本 欧洲时间2022年12月15日,MDCG小组发布了MDR和IVDR下的边界分类手册第二版,这是在今年9月...
One of the key tasks of the MDCG is to provide guidance on the implementation of the Unique Device Identification (UDI) system, which is mandatory for all medical devices placed on the EU market. The UDI system aims to enhance traceability and transparency of medical devices throughout their ...
Medical Device Medical Device Coordination Group Document MDCG 2019-16 rev. 1 MDCG 2019-16 Guidance on Cybersecurity for medical devices December 2019 July 2020 rev.1 This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) ...