近日,MDCG发布了关于医疗器械分类的指南文件MDCG 2021-24 Guidance on classification of medical devices。指南的总体内容分为三大部分:第一部分是对于分类需要涉及到的术语进行界定和解释;第二部分是对于规则总体进行图解;第三部分是对于每一个规则里面的每一种分类进行表格列示解释并给与举例阐述。如我们所知,MD...
近日,MDCG发布了关于医疗器械分类的指南文件MDCG 2021-24 Guidance on classification of medical devices。 指南的总体内容分为三大部分: 第一部分是对于分类需要涉及到的术语进行界定和解释; 第二部分是对于规则总体进行图解; 第三部分是对于每一个规则里面的每一种分类进行表格列示解释并给与举例阐述。 如我们所知...
◆ Background note on the use of the Manual on borderline and classification for medical devices under the Directives ◆ Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v2 - 分类界定结果(每3个月更新一次) ...
One of the key changes introduced by the MDR is the new classification system for medical devices, which is based on potential risk to patients. The regulation also establishes a Unique Device Identification (UDI) system to improve traceability of devices throughout the supply chain. In addition,...
risk classification, conformity assessment procedures, performance evaluation and performance studies, vigilance and market surveillance should be significantly reinforced, whilst provisions ensuring transparency and traceability regarding in vitro diagnostic medical devices should be introduced, to improve health ...
Publication ofMDCG 2021-24Guidance on classification of medical devices. The EUDAMEDUDI/Devices and NBs & Certificates modulesare now open for economic operators and notified bodies. August 2021: Publication ofMDCG 2021-23Guidance for notified bodies, distributors and importers on certification activitie...
1. European Union Medical Device Regulation (EU MDR) Intro 2. Classification of Devices 3. Explanation of Economic Operators 4. The General Safety and Performance Requirements (GSPR) 5. Requirements for the Technical File 6. Risk Management Requirements Unique to the EU MDR ...
MDREU_2017_745欧盟医疗器械最新法规(中英对照版)公报 中⽂版⽴法 L117 第60卷 2017年5⽉5⽇ 内容 I ⽴法法案 法规 ★欧洲议会和理事会于2017年4⽉5⽇签发的关于医疗器械第2017/745号法规,修订了第2001/83/EC号指令,第178/2002号(EU)法规和第1223/2009号 (EU)法规,并废除了理事会第90/...
For more information about classification rules, please visit Guidelines for Classification of Medical Devices.Which category does an In Vitro Diagnostic Medical Device (IVD) fall into? The IVD Directive (98/79/EC) groups IVDs into four categories. These categories are, in order of increasing ...
欧盟官方公报中文版 立法 L117第60卷2017年5月5日 内容 I立法法案 法规★欧洲议会和理事会于2017年4月5日签发的关于医疗器械第2017/745号法规,修订了第2001/83/EC号指令,第178/2002号(EU)法规和第1223/2009号(EU)法规,并废除了理事会第90/385/EEC号和第93/42/EEC号指令(1)···1★欧洲议会和理事会...