mdcg_2022-2_en体外诊断医疗器械(IVD)临床证据的一般原则指南.pdf,Medical Devices Medical Device Coordination Group Document MDCG 2022-2 MDCG 2022-2 Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs) January
中英文对照 MDCG-2020-1 医疗器械软件的临床评价MDR 性能评价IVDR指南.pdf,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) ofMedi
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...
mdcg_2020-2 rev1 第一类过渡条款 第120(3和4)章.pdf,Medical Device Medical Device Coordination Group Document MDCG 2020-2 rev.1 MDCG 2020-2 rev. 1 Class I Transitional provisions under Article 120 (3 and 4) – (MDR) March 2020 July 2020 rev.1 This docume
This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representat...
Medical Device Coordination Group Document MDCG 2019-9 Rev.1 4(24) Introduction The Regulation (EU) 2017/745 on medical devices (1) requires that the manufacturer shall draw up a summary of safety and clinical performance (SSCP) for implantable devices and for class III devices, other than ...
外科侵入的概念应理解为也包括与器官、组织或身体其他部分有侵入性接触的液体,如果这 11 MedicalDevices 医疗器械 MedicalDeviceCoordination GroupDocument MDCG2021-24 医疗器械协调小组文件 些液体是通过手术创造的开口进入的。 For a device that administers a substance, such a substancemust be assessed in its ...
中英文对照 MDCG-2020-1 医疗器械软件的临床评价MDR 性能评价IVDR指南.pdf,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) ofMedi
MedicalDevices 医疗器械 MedicalDeviceCoordination GroupDocument MDCG2019-16Rev.1 医疗器械协调小组文件 MDCG2019- 16Rev.1 GuidanceonCybersecurity formedical devices 医疗器械网络安全指南 December2019 2019.12 July 2020rev.1 2020年7 月rev . 1 This document has been endorsed by the Medical Device Coordina...
外科侵入的概念应理解为也包括与器官、组织或身体其他部分有侵入性接触的液体,如果这 11 MedicalDevices 医疗器械 MedicalDeviceCoordination GroupDocument MDCG2021-24 医疗器械协调小组文件 些液体是通过手术创造的开口进入的。 For a device that administers a substance, such a substancemust be assessed in its ...