内容提示: 龙德出品REGULATION (EU) 2017/745 欧盟医疗器械法规龙德医疗器械工具丛书医疗器械法规中英文对照系供内部学习使用欧盟医疗器械法规(Regulation (EU)2017/745) 中英对照版EU Medical Device Regulations(Regulation (EU) 2017/745)法规原文发布日期 2017 年 5 月 5 日第一版(2019 年 7 月)主编:杨龙 赵...
Regulation (EU) 2017/745 (EU MDR) The EU MDR entered into application on 26 May 2021 If you are a manufacturer, authorised representative, importer or distributor of medical devices in the EU, or a regulatory affairs or quality management professional involved with medical devices, you need to...
For implantable devices, check whether the mandatory information to be supplied to the patient (including the implant card) complies with the MDR and hedges your company sufficiently against product liability risks. For devices that incorporate electronic programmable systems, inc...
Rule3: 增加了用于体外直接从人体或人类胚胎取下体外使用的人体细胞、组织、气管,然后再植入或注入体内,此类器械为III类。 Rule 5-Rule 8:INVASIVE DEVICES侵入性器械 Rule 8:在原来的基础上添加了:有源植入器械或其相关附件,乳房植入物或心脏修补网状织物,完整或部分关节置换物,直接与脊柱接触的椎间盘置换植入物...
Under the new Regulation, medical devices are divided into four risk classes. Depending on the risk class of the product, a different conformity assessment procedure is foreseen before the product can be placed on the EU market. In case of medium or high risk classes, Notified Bodies might be...
The EU has gradually increased the degree of convergence in medical devices, even though medical devices pertain to the health sector, which is within the Member States' competence. Despite MDR being a regulation, its preamble states that its aim is to harmonize rules for the p...
On 15 March 2023, the Regulation (EU) 2023/607 was formalised, which provides medical device manufacturers more time to certify medical devices to mitigate the risk of shortages. The amended regulation introduces a longer transition period for products already on...
(14) Safety aspects addressed by Directive 2014/30/EU of the European Parliament and of the Council ( 1 ) are an integral part of the general safety and performance requirements laid down in this Regulation for devices. Consequently, this Regulation should be considered a lex specialis in ...
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 ...
MedicalDevices MedicalDeviceCoordinationGroupDocumentMDCG2021-5Rev.1 MDCG2021-5Rev.1 Guidanceonstandardisationformedicaldevices Revision1–July2024 ThisdocumenthasbeenendorsedbytheMedicalDeviceCoordinationGroup (MDCG)establishedbyArticle103ofRegulation(EU)2017/745.TheMDCGis ...