上个月，美国方面要求欧盟将新医疗器械法规和体外诊断医疗器械法规（MDR/IVDR）的实施期限推迟3年。随后，欧盟委员会（EC）发布了一份文件，文件中将美国和欧盟之间的两种不同监管控制定性为贸易壁垒。
此前，美国敦促欧盟推迟实施MDR/IVDR，以便美国出口商可以适应新法规的要求。然而，欧盟随后向世贸组织委员会表示，“目前没有理由对两种新法规的过渡期进行任何变更。”欧盟委员会在7月25日发布的文件中宣称，美欧之间的贸易平衡属于真正的双赢，而双方的贸易流量相差不到10%。欧盟委员会另外表示，美国是欧盟的主要医疗器械供应商，占欧盟进口医疗器械的55%以上。欧盟委员会还指出，美欧双方都依赖同一国际标准化组织（ISO）标准（即ISO 13485），同时表明这有助于“降低业界的标准采用成本，并能促进价值链的整合。”国际上公认的ISO 13485质量管理体系标准在美国和欧盟等不同国家地区得到了广泛采用。美欧双方业界对于ISO 13485: 2016采用情况的不同之处在于，美国至少在目前看来仍属于自愿性采用，而欧盟已要求在今年3月份前过渡到修订后的ISO 13485: 2016标准。美国监管机构计划将质量体系法规从21 CFR PART 820过渡到ISO 13485: 2016。“但在审批和检查方面，还可能做得更多，”欧盟委员会表示，“欧美双方的体系仍然存在分歧，从而导致出现了双重控制现象。”具体而言，欧盟委员会指出，美国上市前批准（PMA）、生产场地控制和检查属于贸易壁垒。欧盟委员会列举了三种打破贸易壁垒的方法，并写道：“欧盟和美国监管机构正在携手合作，确保双方的符合性评定机构：1）尽可能遵循相同的程序，2）彼此互认对方的相关工作，从而避免重复控制，以及3）采取其他贸易便利化行动，如采用双方所兼容的产品标识系统”。接下来需要采取旨在寻求与标准开发组织（SDO）能够更好合作的新措施（即：今年3月份CDRH中心就ISO 13485标准提出了新的IMDRF工作项），而美国FDA和欧盟委员会都是国际医疗器械监管机构论坛（IMDRF）的成员。同时，IMDRF此前对外发布了三份关于唯一器械标识（UDI）最终文件，随后美欧双方也提出要向各自的UDI系统过渡。今年早些时候，美国和欧盟承诺就UDI规范方面进行合作。欧盟委员会主席容克（Jean-Claude Juncke）上个月访问白宫之后，欧盟委员会随即发布了前文开始部分所提到的这份文件。7月25日，美国和欧盟在以下方面达成共识：将通过携手合作的方式，努力实现对非汽车行业产品的零关税、零非关税壁垒和零补贴，并同意减少壁垒，同时扩大服务、化学品、药品、医疗产品和大豆贸易。
EC Cites Regulatory Controls for Medical Devices as US-EU Trade Barriers
After the US requested a three-year delay to the EU’smedical device and in vitro diagnostic regulations (MDR/IVDR) last month, the European Commission (EC) released a document identifying two types of divergent regulatory controls in the US and the EU as barriers to trade.The US urged the delay to“allow for US exporters toadapt to the new requirements,” but the EU had earlier stated to a World Trade Organization (WTO) committee that “there are no grounds for the time being” to amend the transitional periods of the new regulations.In the 25 July document, the EC touts “a balanced trade between the US and the EU that is a real win-win” and a less than 10% difference in trade flow. The EC adds that the US is the EU’s main medical device supplier, representing more than 55% of all medical devices imported tothe EU.The EC also points to both countries’ reliance on the same International Organization for Standardization (ISO) standards, noting this allows for “lowering adaption costs for industry and facilitating the integration of the value chain.” The globally agreed-upon standard on quality management systems—ISO 13485—is widely adopted in the US and the EU, among other countries. Industry adoption of 13485:2016 in the US versus in the EU differs in that it remains voluntary in the US at least for the time being, whereas the EU required transitioning to the revised standard by March. US regulators plan to transition from 21 CFR 820 to 13485:2016.“But there is potential to do more inthe area of approvals and inspections,” the EC states. “Our systems remain divergent, resulting in double controls.” Specifically, the EC points to US premarket approvals, manufacturing site controls and inspections as barriers to trade.The EC lists ways to break down the barriers, writing that “EU and US regulators are working together to ensure that conformity assessment bodies on both sides follow the same procedures as much as possible, recognize each other's work to avoid duplication of controls” as well as“engage in other trade facilitating actions, such as compatible product-identification systems.”The next steps speak to new efforts to better collaborate with standards development organizations, with FDA and the EC bothserving as members of the International Medical Device Regulators Forum (IMDRF). They also coincide with both countries' transitions to their respective unique device identification (UDI) systems, following IMDRF effortson UDI. The US and the EU pledged to cooperate on specifications for unique device identifiers earlier this year.The EC's document comes after EC President Jean-Claude Juncker's visit to the White House last month. The US and the EU agreed on 25 July “to work together toward zero tariffs, zero non-tariff barriers and zero subsidies on non-autoindustrial goods” and “to reduce barriers and increase trade in services, chemicals, pharmaceuticals, medical products, as well as soybeans.”
来源：RAPS
原文链接：https://www.raps.org/news-and-articles/news-articles/2019/8/ec-cites-regulatory-controls-for-medical-devices-a
整理翻译：奥咨达
