【奥译言】欧盟对MDR/IVDR进行第一次勘误

2019-03-25 09:36 阅读数：3481 标签：

欧盟理事会本周发布了两份勘误表，以纠正MDR/IVDR中所存在的错误以及上下文不一致之处，并对其条款稍作了修改。

尽管这些勘误表并不会影响企业的过渡期限（有人曾希望I类器械企业能有一个喘息的机会），但勘误表确实让我们看到了监管规定中可能存在混乱或需要稍作调整的地方。

▍MDR勘误表

MDR勘误表共涉及14处纠正，其中一些纠正内容很简单，例如将MDR第2条和第7条中的“trademark”一词改为了“trade mark”，还有一些涉及语法上的变化，而另一些纠正，如第7处，将意味着2020年5月26日之前按照成员国现行有效的规则可以合法在有关成员国境内投放市场或交付使用的动物源性产品，在该过渡日期之后将不再允许其在有关成员国境内投放市场或交付使用。

在关于基于质量管理体系符合性评定的附录IX中，勘误表将“适用于IIa类、IIb类和III类器械的监督评估”改为“监督评估”。

另一处纠正扩大了器械附件的分类范围，修改了附录VII第3.2节中的一行内容，原文为：“......医疗器械的附件以及附录XVI所列产品的附件应与其一起使用的器械分开进行分类（依照自身的特性进行分类）......”，现改为“......医疗器械的附件应与其一起使用的器械分开进行分类（依照自身的特性进行分类）......”。

▍IVDR勘误表

IVDR勘误表包含17处纠正，其中包括一些与MDR改动相吻合的小改动，还有一些是语法错误纠正，以及其他可能产生更大影响的修改。

例如，第1处纠正【第183页，序言（66）】将“性能研究的规则应符合该领域已被广泛接受的国际指南文件，如ISO 14155: 2011《以人作为受试对象的医疗器械的临床研究 - 临床试验质量管理规范》”中的国际标准改为“ISO 20916《体外诊断医疗设备 - 人体样本的临床性能研究》”。

针对附录IX的另一处纠正（即第16处纠正）扩大了需要进行技术文件评估的器械范围。

原文为：“对于C类器械，监督评估还应包括针对有关器械（根据本附录第2.3节第3段所述的由公告机构记录的样品选择理由进一步选取的代表性样品）进行的本附录第4.4～4.8节所述的技术文件评估。”现改为：“对于B类和C类器械，监督评估还应包括针对有关器械（根据本附录第2.3节第3段所述的由公告机构记录的样品选择理由进一步选取的代表性样品）进行的本附录第4节所述的技术文件评估。”

英文原文

EU Publishes First Corrigenda for MDR, IVDR

As part of an effort to fix the mistakes, inconsistencies and slightly correct the EU’s Medical Device and In Vitro Diagnostic Regulations (MDR/IVDR), the Council of the European Union this week released two corrigenda.

Although the documents do not alter the transition deadlines for companies (some had hoped there might be a break for struggling class I device companies), the corrigenda do offer a look into areas of the regulations where there may have been confusion or where slight tweaks were necessary.

On the MDR side, there are 14 corrections, with some as simple as changing the word “trademark” to “trade mark” in Articles 2 and 7, or grammatical changes, while others, such as correction number 7, will mean that products of animal origins legally placed on the market prior to 26 May 2020 will not be allowed on the market after that transition date in such member states that previously allowed them.

In Annex IX, which concerns conformity assessments based on a quality management system, the corrigendum corrects the text from “Surveillance assessment applicable to class IIa, class IIb and class III devices” to just “Surveillance assessment.”

Another correction broadens what device accessories will be classified, changing a line in Annex VII, Section 3.2 that reads: "… Accessories for a medical device and for a product listed in Annex XVI shall be classified in their own right …", to: "… Accessories for a medical device shall be classified in their own right … ".

The IVDR corrigendum, meanwhile, includes 17 corrections, with some minor tweaks that match the MDR changes, corrections of grammatical errors and others that may have more of an impact.

For instance, in the first correction, on page 183, Recital (66), the line explaining how the “rules on performance studies should be in line with well-established international guidance in this field, such as the international standard ISO 14155:2011 on good clinical practice for clinical investigations of medical devices for human subjects” changes the international standard to “ISO 20916 on clinical performance studies using specimens from human subjects, currently under development.”

Another correction, number 16, to Annex IX broadens what devices will need technical documentation assessments.

The original line: "In the case of class C devices, the surveillance assessment shall also include an assessment of the technical documentation as referred to in Sections 4.4 to 4.8 of for the device or devices concerned on the basis of further representative …" now reads: “In the case of class B and C devices, the surveillance assessment shall also include an assessment of the technical documentation as specified in Section 4 for the device or devices concerned on the basis of further representative …"

来源：RAPS

原文链接：https://www.raps.org/news-and-articles/news-articles/2019/3/eu-publishes-first-corrigenda-for-mdr-ivdr

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