MDR法规
1、成员国有责任逐案例确认，各产品是否属于本法规范围。为确保所有成员国的相关判断力一致，特别是在灰区临界情况下，在咨询医疗器械协调小组（MDCG）后，应允许委员会主动或经成员国适时且有根据地请求，逐案决定某一具体产品、类别或产品组是否属于本法规适用范围。在审议涉及药品、人体组织和细胞、生物灭活产品或食品之临界案例所辖产品之监管状况时，委员会应确保欧洲药品管理局、欧洲化学品管理局和欧洲食品
安全局的适当咨询水平。
翻译：
It should be the responsibility of the Member States to decide on a case-by-case basis whether or not a
product falls within the scope of this Regulation. In order to ensure consistent qualification decisions in that regard across all Member States, particularly with regard to borderline cases, the Commission should be
allowed to, on its own initiative or at the duly substantiated request of a Member State, having consulted the Medical Device Coordination Group (‘MDCG’), decide on a case-by-case basis whether or not a specific product, category or group of products falls within the scope of this Regulation. When deliberating on the regulatory status of products in borderline cases involving medicinal products, human tissues and cells, biocidal products or food products, the Commission should ensure an appropriate level of consultation of the European Medicines Agency (EMA), the European Chemicals Agency and the European Food Safety Authority, as relevant.
单词扫盲
qualification decisions：资格认定
MDCG：医疗器械协调小组
category：种类；类别
borderline： 分界线，国界线
Commission：正式委托；任命…为军官 n. 委员会
duly：恰当地；正如预期地
deliberating:咨询，磋商；会诊；查阅
consultation:咨询，磋商；会诊；查阅
EMA:欧洲药品管理局
2、由于在某些情况下医疗器械和美容产品难以区分，因此欧盟议会和理事会第 1223/2009 号法规（2）中也应加入
对某一产品法规状况的欧盟范围统一决议。
翻译：
Since in some cases it is difficult to distinguish between medical devices and cosmetic products, the
possibility of taking a Union-wide decision regarding the regulatory status of a product should also be
introduced in Regulation (EC) No 1223/2009 of the European Parliament and of the Council (6).
单词扫盲
distinguish:区分
cosmetic:化妆品; 美容产品
Union-wide decision:全联盟统一决定
3、药械组合类产品将按照本法规或欧洲议会和理事会第 2001/83/EC 号指令（3 ）进行管理。在涉及该药械组合产品的警戒活动（这里也可以理解为监管）中，在上市前评估咨询及信息交换期间，两项立法法案应确保适当的相互关联。对于药械组合产品，应当在该医疗产品上市许可背景下，充分评估其是否符合本法规中规定的通用安全与性能要求。因此，应修订第 2001/83/EC 号指令。
翻译：
Products which combine a medicinal product or substance and a medical device are regulated either under this Regulation or under Directive 2001/83/EC of the European Parliament and of the Council. (7) The two legislative acts should ensure appropriate interaction in terms of consultations during pre-market assessment, and of exchange of information in the context of vigilance activities involving such combination products. For medicinal products that integrate a medical device part, compliance with the general safety and performance requirements laid down in this Regulation for the device part should be adequately assessed in the context of the marketing authorisation for such medicinal products. Directive 2001/83/EC should therefore be amended.
单词扫盲
Parliament：议会
legislative: 立法
integrate：结合 整合
compliance：合规
adequately：充分的
authorisation:授权
amended: 修订
不难发现里面有很多重复的单词哦，推荐大家用艾宾浩斯记忆去记单词！和我们持续打卡吧！
医械香猪
