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
For dual-purpose devices, which are devices with a medical and a non-medical intended purpose, this guidance applies only to the non-medical intended purpose. 本MDCG指南是涉及基于与现有器械相关的数据,以根据MDR获得CE认证而进行的等同性证明,适用于MDR附件XVI所列的无预期医疗用途的产品和通用规范所...
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) ...
MedicalDevices MedicalDeviceCoordinationGroupDocumentMDCG2021-5Rev.1 Guidanceonstandardisationformedicaldevices Introduction:scopeandcontents Thisdocumentaimstoprovideguidanceondifferentaspectsrelatedtostandardsinthemedical devicessectorinsupportoftherequirementslaiddownintheapplicableEUlegislation,taking ...
Medical Devices Medical Device Coordination Group Document MDCG 2021- 24 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 ...
On June 10th, 2020, the Medical Device Coordination Group (MDCG) released its guidance on transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product and which has action ancillary to that of the device, as well as on ...
This document has been endorsed by theMedical 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 representative of the European Commission. The document is not a European ...
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 ...
1 Medical Devices Medical Device Coordination Group Document MDCG 2021-5 Guidance on standardisation for medical devices Introduction: scope and contents This document aims to provide guidance on different aspects related to standards in the medical devices sector in support of the requirements laid ...
The European Union's Medical Device Coordination Group (MDCG) plays a crucial role in ensuring the safety and effectiveness of medical devices on the European market. The MDCG provides guidance and support to member states and stakeholders in implementing the EU medical device regulations to ensure...