【奥译言】仅27%受访者符合要求？调查结果明显表明业界尚未准备好“迎接”欧盟MDR

2019-09-27 16:07 阅读数：3284 标签：

RAPS/KPMG针对200多个医疗器械行业领袖进行的一项新调查发现，只有27％的受访者表示他们将完全满足自2020年5月26日起全面实施的新欧盟医疗器械法规（MDR）的要求。

近一半的受访者表示，由于新法规的出台，他们可能会中止或退出医疗器械市场。约半数受访者还表示，他们将根据MDR过渡性条款，在2024年之前继续在欧盟市场销售他们目前的医疗器械，同时开展合规计划。

在调查结果对外公布的同时，专家们还聚集在费城RAPS会议上讨论了一些与欧盟医疗器械法规和体外诊断医疗器械法规（MDR/IVDR）有关的痛点和下一步计划，其中IVDR将于2022年5月强制执行。

英国药品和保健康产品管理局（MHRA）的器械临床主任Duncan Mcpherson告诉与会者，该机构已经向欧盟委员会提交了一份提案，要求对I类可重复使用器械的执行时间表进行二次更正，包括一些正在升级的软件。

正如有些人警告说，此次更正仍处于提议阶段，McPherson表示，他们也正在制定备用计划，以防欧盟委员会不接受更正提议。

与此同时，专家们对接下来会发生的情况予以警告。公告机构TÜV SÜD副总裁Bassil Akra解释说，即使欧盟委员会在明年5月之前指定20个公告机构（目前指定了4个），相关工作量也大到无法完成，尤其是在企业必须同时处理新旧监管体系的情况下。

此外，Akra还交代了欧盟委员会发布的各个指南文件将会增加哪些要求和负担，而不是围绕MDR进行解释说明。目前尚未发布关于IVDR的指南文件。

Akra还讨论了业界想要了解MDR在哪些方面进行了器械相关重大变更的迫切程度，但欧盟委员会并未提供任何答案。Akra表示：“因此，我们正在寻求在不同公告机构之间通用的解释，并准备将其对外公开。”

雅培监管策略高级总监Philippe Auclair补充说，他认为MDR也将影响其它市场，因为许多公司将欧洲作为开拓全球市场的起点。

英文原文

27% Will be Compliant Survey Highlights Lack of Readiness for EU MDR

A new RAPS/KPMG survey of more than 200 medical device industry leaders found that only 27% said they will be fully compliant with the new EU Medical Devices Regulations (MDR) set to go into effect 26 May 2020.

Almost half of respondents also said they will likely discontinue or withdraw medical devices from the market because of the new regulation, and about half also said they will leverage the MDR’s transitional provisions to continue to sell their current devices in the EU through 2024 while working on their compliance programs.

Coinciding with the release of the survey’s results, experts gathered at RAPS’ Convergence in Philadelphia to discuss some of the pain points and next steps related to MDR and the in vitro diagnostic regulation (IVDR), which is set to take effect two years after MDR.

Duncan McPherson, clinical director of devices at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), told attendees that a proposal has been submitted to the European Commission for a second corrigendum to change the timetable for Class I reusable devices, including some software, that are being up classified.

As others warned that this corrigendum is still inthe proposal stage, McPherson said they are working on backup plans, too, if the Commission does not accept the corrigendum.

Meanwhile, experts warned of what’s to come. Bassil Akra, VP of notified body TÜV SÜD, explained how even if the European Commission designates 20 notified bodies by next May (four are currently designated), the workload will not be doable, especially as companies have to deal with the old and new regulatory systems simultaneously.

Akra also explained how the Commission guidance documents are adding requirements and burdens instead of explaining MDR. And for IVDR, no guidance has been released.

He also discussed how industry wants to know what are considered significant changes to devices in terms of MDR, but the Commission is not providing any answers. “So, we’re developing a kind of common interpretation among notified bodies, which we will circulate and publish,”Akra said.

Philippe Auclair, senior director for regulatory strategy at Abbott, added that he thinks other markets will be impacted by MDR as well, because so many companies use Europe as a launch base for markets worldwide.

来源：RAPS

原文链接：https://www.raps.org/news-and-articles/news-articles/2019/9/27-will-be-compliant-survey-highlights-lack-of-r

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