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...
Medical Device Medical Device Coordination Group Document MDCG 2020-5 MDCG 2020-5 Clinical Evaluation - Equivalence A guide for manufacturers and notified bodies April 2020 This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU)...
Medical Devices MDCG 2021- 24 Medical Device Coordination Group Document MDCG 2021-24 Guidance on classification of medical devices October 2021 This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is...
Guidance Classification Classification of medical devices under the MDR (MDCG 2021-24) ec.europa.eu/health/sys Guidance Classification Classification Rules for IVDs under the IVDR (MDCG 2020-16) health.ec.europa.eu/lat Manual Classification Manual on borderline and classification for medical devices ...
(medical device regulation), provides a possibility to use clinical data related to an equivalent device in the clinical evaluation required for a device under conformity assessment2 . Whilst carrying out a clinical investigation is the most direct way to generate clinical ...
MDCG 2020-7_guidance_pmcf_plan_template_en
MedicalDevices 医疗器械 MedicalDeviceCoordination GroupDocument MDCG2020-1 医疗器械协调小组文件 MDCG2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation(IVDR) ofMedicalDevice Software 医疗器械软件的临床评价 (MDR)/性能评价 (IVDR)指 南 March2020 2020.03 This document has been endorsed by...
The guideline MDCG 2019-11 clarifies that software whichis driving or influencing is covered by the medical devices regulations eitheras a part/component of a device or as an accessory for a medical device. 应该注意的是,软件可以通过驱 动或影响另一个医疗设备的使用而与之关联。MDCG 2019-11...
13MDCG2022-5Guidelineonborderlinebetweenmedicaldevicesandmedicinalproductsunder Regulation(EU)2017/745onmedicaldevices. 9 MedicalDevice MedicalDeviceCoordinationGroupDocumentMDCG2024-5 Forclassification,relevantguidanceisavailableinMDCG2021-2414,MDCG2019-1115and MDCG2023-516.Classificationunderpreviouslegislation,i...
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...