EUCTP A0161 Chinese Medical Device Study_CN

欧盟医疗器械法规(eu) 2017-746（英文+中文版）Regulation (EU) 2017/746 on medical devices, also known as the Medical Devices Regulation (MDR), is a comprehensive piece of legislation that sets out the rules and requirements for medical devices in the European Union. The regulation was adopted on April 5, 2017, and will fully apply starting from May 26, 2021. It replaces the previous Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD).The main objective of the MDR is to ensure the safety and performance of medical devices while promoting innovation and access to market for manufacturers. The regulation introduces several new requirements for medical devices, including stricter pre-market assessment procedures, enhanced post-market surveillance obligations, and improved traceability and transparency.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, the MDR requires manufacturers to provide more clinical evidence forhigh-risk devices and to demonstrate compliance with general safety and performance requirements.The MDR also strengthens the role of notified bodies, which are responsible for assessing the conformity of medical devices with the regulatory requirements. Notified bodies must now meet higher standards of competence and independence, and are subject to stricter supervision by national authorities.Overall, the MDR aims to improve the safety and effectiveness of medical devices on the EU market, while also enhancing the transparency and predictability of the regulatory framework. By ensuring that medical devices meet high standards of quality and performance, the regulation ultimately benefits patients, healthcare professionals, and manufacturers alike.。

force and date of application 生效和应用日期
• 1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. 本法 规应在《欧盟官方公报》上公布后第20天生 效。
• (c) advanced therapy medicinal products covered by Regulation (EC) No 1394/2007;欧洲委员会第1394/2007号法规所涵盖的前沿疗法医药产品；
• (d) human blood, blood products, plasma or blood cells of human origin or devices which incorporate, when placed on the market or put into service, such blood products, plasma or cells, except for devices referred to in paragraph 8 of this Article;人类血液或血液制品、人源的血浆或血细胞， 或者在投放市场或投入使用时，包含此类血液制品、血浆或细胞的器 械，但本条第8段所述的器械除外（8. 包含物）；
• 2. It shall apply from 26 May 2020. 自2020年5 月26日起适用。
• 3. By way of derogation from paragraph 2（略）
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COVID-19 预防相关医疗设备欧洲标准中英文Brussels 20 March 2020 - In response to the coronavirus outbreak, CEN, the European Committee for Standardization, and CENELEC, the European Committee for Electrotechnical Standardization, agreed, in collaboration with all their Members and after the urgent request from the European Commission, to make freely available a series of European standards (ENs) for medical devices and personal protective equipment used in the context of the COVID-19 pandemic.This exceptional decision is motivated by the need to tackle the severe shortage of protective masks and medical equipment experienced all around Europe due to the exponential growth of the COVID-19 emergency. The standards will enable a quicker and smoother access to market of new fundamental medical and protection equipment. Providing free access to the national adoptions of this set of European standards facilitates the work of the many companies within the European Economic Area which are reconverting their production lines to deliver tangible results quickly and ensure that healthcare professionals and patients have access to the equipment they urgently need. The 11 standards developed by CEN and potentially 3 additional ones developed jointly with ISO made available cover common filtering masks, medical gloves and protective clothing. They are the fruit of a collective European effort. These Europeanstandards were developed and adopted by different Technical Bodies, taking into account the contributions of hundreds of experts and stakeholders in the personal protective equipment and medical field all around Europe. The standards are available for free download from the websites of CEN national members. Thierry Breton, European Commissioner for the Internal Market, saluted the init iative: “In our battle against the coronavirus we need to act with urgency, solidarity and in a coordinated manner. We need audacity and innovative ways of producing the equipment we need. I am encouraging manufacturers to evaluate the possibilities of increasing and diversifying production, building on positive examples such as textile and shoe manufacturers starting to produce masks and gowns. I will do everything possible to support their efforts. I am pleased to announce that following contacts with the Commission, today CEN and CENELEC agreed to make freely available the standards needed for such companies to be able to produce masks and other protective equipment. This agreement has immediate effect.”Vincent Laflèche, CEN President, commented: “Due to the coronavirus pandemic, we are living unprecedented circumstances which require exceptional measures. By making a set of standards available for free, the European standardization community is committed to help the European Commission in its effort to build the first common European reserve of emergency medical equipment (RescEU)”. Dany Sturtewagen,CENELEC President, added: “European standards play a crucial role in ensuring the availability of key medical devices and personal protective equipment. This extraordinary step is in line with the key drivers of our European standardization work: inclusiveness and unity. I salute the reaction of solidarity and commitment from our Members to support the global fight against COVID-19”. The list of the standards follows:EN 149:2001 + A1:2009 Respiratory protective devices –Filtering half masks to protect against particles - Requirements, testing, marking (commonly referred to as ‘FFP masks’)EN 14683:2019 Medical face masks - Requirements and test methodsEN 166:2001 Personal eye-protection – SpecificationsEN 14126:2003 + AC 2004 Protective clothing - Performance requirements and tests methods for protective clothing against infective agentsEN 14605:2009 + A1:2009 Protective clothing against liquid chemicals - performance requirements for clothing with liquid-tight(Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body onlyEN 13795-1:2019 Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gownsEN 13795-2:2019 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methodsEN 455-1:2000 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes (MDD)EN 455-2:2015 Medical gloves for single use - Part 2: Requirements and testing for physical properties (MMD)EN 455-3:2015 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation (MDD)EN 455-4:2009 EN Medical gloves for single use - Part 4: Requirements and testing for shelf life determination (MDD)In addition, possibly:EN ISO 374-5:2016 Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risksEN ISO 13688:2013 Protective clothing - General requirementsEN ISO 10993-1:2009 + AC 2010 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process后面是中文版本布鲁塞尔2020年3月20日——为应对新冠病毒COVID-19爆发，应欧委会紧急要求，欧洲标准化委员会与欧洲电工标准化委员会（CEN-CENELEC）与成员国达成共识，免费提供一系列医疗设备和个人防护设备的欧洲标准。

MDREU_2017_745欧盟医疗器械最新法规（中英对照版）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)★欧洲议会和理事会于2017年4⽉5⽇签发的关于体外诊断医疗器械第2017/746号（EU）法规并废除了第98/79/EC号指令和理事会第2010/227/EU号决议 (176)________________（1）EEA相关性⽂本。

以浅⾊字体打印标题的法案均为涉及农业⽇常管理的法案，⼀般在有限期内有效。

所有其他法案的标题均以粗体打印，并以星号开头。

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（EEA相关性⽂本）欧洲议会和欧盟委员会，考虑到“欧盟运作条约”，特别是其中第114条和第168（4）（c）条规定，并考虑到欧盟委员会提案，于⽴法草案转交各国议会后，考虑到欧洲经济和社会委员会之意见（1），在咨询地区委员之后，根据⼀般⽴法程序运作（2），鉴于：(1)理事会第90/385/EEC号指令（3）和理事会第93/42/EEC号指令（4）构成有关医疗器械（不包括体外诊断医疗器械）的欧盟监管框架。

但需要对该指令进⾏⼤幅修订，以便建⽴稳健、透明、可预测和可持续的医疗器械监管框架，以确保⾼⽔平的安全和健康，同时为创新提供⽀持。

Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regulatoryframework for medical devices, other than in vitro diagnostic medical devices. However, a fundamentalrevision of those Directives is needed to establish a robust, transparent, predictable and sustainableregulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation. (2)本法规旨在确保区域内医疗器械市场的平稳运作，在为患者和使⽤者提供⾼⽔平健康保护的基础上，同时考虑到活跃于本⾏业的中⼩型企业利益。