美国对欧盟医疗器械法规和体外诊断医疗器械法规（MDR/IVDR）的若干问题提出“严重关切”，并呼吁欧盟推迟3年实施MDR/IVDR。美国在7月24日世界贸易组织（WTO）技术性贸易壁垒委员会发表的声明中，探讨了业界就MDR/IVDR所面临的问题。“美国业界为能否继续进入欧盟市值1250亿美元的医疗器械市场感到担忧，而其中200亿美元源自美国产品。”距离MDR正式施行日期（2020年5月26日）还剩下不到9个月时间，美国代表团在7月24日发表的声明中强调了两个问题。这两个问题具体涉及欧盟新监管体系实施情况要落后于预定计划的情况：一是缺乏根据MDR/IVDR所指定的公告机构（而公告机构可以帮助业界实现向MDR/IVDR的及时过渡），二是缺乏有助于确保新产品标准符合性的实施细则。美国敦促欧盟将MDR/IVDR的实施时间延迟3年，以便“美国出口商可以适应新法规的要求”，原因正在于该国代表团在世贸组织技术性贸易壁垒委员会发表的声明中所提出的担忧。“如果无法做到这一点（即：将施行时间延迟3年），我们极力主张欧盟允许于2024年之前在市场上销售目前被认为是安全的遗留产品（新法规MDR/IVDR实施后依据MDD/IVDD 签发的有效证书仍在市场销售的器械），并请求公告机构优先考虑需要新认证的器械，而非重新认证的器械。”迄今为止，欧盟委员会（EC）仅指定了两家满足新法规MDR要求的公告机构（即英国BSI和TÜVSÜD），此外还没有任何一家针对IVDR的公告机构获得指定。欧盟委员会还提出了两个MDR/IVDR实施细则，而截至查询当天只通过了其中一个。欧盟委员会于2017年11月通过了关于旨在明确MDR/IVDR指定公告机构所涵盖的指定范围而制定一份产品代码及对应器械类型清单的实施细则，并于今年7月份根据MDR发布了关于一次性使用医疗器械再处理通用规范的实施细则草案。欧盟委员会仍预计，到2019年底，将新增20个指定公告机构。然而，美国方面表示，欧盟成长总署（DGGROW）预计今年年底前将获得指定的公告机构仅为12家，同时美国还认为公告机构总数不足以“确保在MDR施行日期（2020年5月26日）和IVDR施行日期（2022年5月26日）之前持续获得监管批准”。美国指出目前还缺乏实施细则，并表示，“欧盟标准化机构因此无法开展制定业界用于确保符合MDR/IVDR要求的标准相关工作”。欧盟委员会标准化请求草案于今年6月份刚刚公布，招来了某个行业组织的批评声音，该行业组织敦促欧盟标准化机构拒绝欧盟以当前方式所提出的请求。根据美国方面发表的声明，“业界坚持认为，截止日期之前将无法完成符合MDR要求所需的产品标准”。（注：欧盟委员会标准化请求草案，即欧盟委员会于今年6月份要求欧洲标准化委员会（CEN）和欧洲电工标准化委员会（CENELEC）起草对现有标准的修订，并制定新标准，以响应欧盟医疗器械法规和体外诊断医疗器械法规（MDR/IVDR）的要求）美国声明还指出，旨在帮助业界缓解过渡期压力的MDR/IVDR条款（包括立法中有关仓储和宽限期的条款）还“不够充分”。然而，欧盟在7月18日发布的声明中向世贸组织委员会表示，“目前没有理由对过渡期进行任何修正。”关于公告机构的指定现状，欧盟表示，新指定的公告机构的最终数量将“与当前情况相比略低”，并且“许多”公告机构根据其申请准备程度可能需要一些时间才能提交指定申请，因为新法规的明确目标之一是建立更安全的公告机构基础设施。Qserve Consultancy公司的执行董事兼合伙人Gert Bos最近向Focus解释说明了业界可能对“公告机构领域内部整顿”立法意图有何期望，事实上内部整顿已经发生。有三家公告机构正式申请或至少暂时正在申请MDR和IVDR框架下的指定，从而增加了一系列不确定性。然而，欧盟补充道，其“承诺采取措施鼓励公告机构采用医疗器械单一审核程序（MDSAP）的审核报告”，但需要以符合欧盟立法要求的方式进行。据报道，欧盟正在为此编写一系列指南文件，预计将于今年年底前完成相关工作。
EU MDR/IVDR: US Raises ‘Serious Concerns,’ Urges 3-Year Implementation Delay
The US raised “seriousconcerns” with several issues regarding the EU’s medical device and in vitrodiagnostic regulations (MDR/IVDR) and called on the EU to delay MDR/IVDR implementation by 3 years.In a 24 July statement to the World Trade Organization’s (WTO) Committee on Technical Barriers to Trade, theUS discusses the MDR/IVDR issues facing industry. “Our industry is worriedabout their continued access to the EU's USD 125 billion medical device market, USD 20 billion of which is supplied by US products.”With just about nine monthsleft before MDR’s 26 May 2020 date of application, the 24 July statement fromthe delegation of the US highlights two issues that specifically concern theimplementation of the EU's new regulatory system being behind schedule. Theissues relate to the ongoing lack of notified bodies (NBs) designated against MDR/IVDR to support timely transitions and implementing acts to help ensurecompliance with new product standards.The US urges the EU to delay MDR/IVDR implementation by 3 years to “allow for US exporters to adapt to thenew requirements” due to the concerns it cites in its statement to the WTO's committee. “If that is not possible, we urge the EU to allow for legacyproducts that are currently deemed safe to be sold on the market until 2024 andto ask” that NBs prioritize devices in need of new certification over thosebeing recertified.The European Commission (EC) has designated only two NBs—BSI UK and TÜV SÜD—against MDR so far and none against IVDR. It has also set forth only two of the MDR/IVDR implement ingregulations—just one of which has been adopted so far. The EC adopted the implementing regulation on the list of codes for designating NBs under MDR/IVDRin November 2017 and it issued the draft implementing regulation on the common specifications for the reprocessing of single-use medical devices in accordance with MDR last month.The EC still estimates designating 20 more NBs by the end of 2019. Yet the US says that DG GROW’sexpectation is for just 12 NBs to be designated by year’s end, arguing that this total would be insufficient to “ensure continued regulatory approvals by May 2020” and by IVDR’s 26 May 2022 date of application.The US points to the lack of implementing regulations in stating that “EU standardizing bodies cannot beginwork on developing the standards industry may use to comply” with MDR/IVDR. TheEC’s draft standardization request, which was just posted in June, drew criticism from an industry group that urged EU standardizing bodies to rejectthe EC's request in its current form. "Industry maintains that the product standards necessary for compliance with MDR cannot be completed before the deadline,” according to the statement from the US.The US statement further argues that the MDR/IVDR provisions intended to provide industry with transitional relief, which include the legislation's provisions for warehousing and the grace periods, have been “insufficient.”An EU statement from 18 July, however, tells the WTO's committee that, "there are no grounds for the time being to explore any amendment to the transitional periods." On the current status of NBs' designation, the EU states that the final number of newly designated NBs will be "slightly lower compared to the current situation" and that "it could take some time for many" NBs to submit their applications based on their preparedness level because "one of the declared objectives of the new regulation is to have in place a safer" NB infrastructure.Gert Bos, executive director and partner at Qserve consultancy, recently explained to Focus what industry could expect from the legislation's intent to "clean house in the NB field," which is already happening. Three NBs have officially or at leasttemporarily against applying for MDR and IVDR, adding to the pile ofuncertainty.Yet the EU adds that it is "committed to take stepsto encourage" NBs to use audit reports from the Medical Device Single Audit Program "in a manner that is compatible with EU legislative requirements." It expects finalizing its work on guidelines for such purposes, which is reportedly already underway, by year's end.
来源：RAPS
原文链接：https://www.raps.org/news-and-articles/news-articles/2019/8/eu-mdrivdr-us-raises-serious-concerns-urges-3
整理翻译：奥咨达
