【奥译言】CDRH就标准提出了新的IMDRF工作项

2019-03-28 09:22 阅读数：3788 标签：

医疗器械业界人士和全球监管机构希望通过新提出的联络计划，进一步促进与标准开发组织（SDO）的合作。

上周，俄罗斯举办了一场由国际医疗器械监管机构论坛（IMDRF）标准工作小组和全球诊断影像、医疗信息技术与放射治疗贸易协会（DITTA）主办的研讨会。在该研讨会上，美国食品药品监督管理局（FDA）器械和放射健康中心（CDRH）标准项目主任Scott Colburn提出了一个新的IMDRF工作项（NWI）。

新工作项提案（NWIP）旨在为IMDRF设定新参数，使其与国际电工委员会（IEC）和国际标准化组织（ISO）建立联络。在此之前，IMDRF已于去年与ISO TC 210 (即ISO 13485工作小组)和IEC TC 62建立了联系。

Colburn表示，如果IMDRF管理委员会对新工作项提案予以批准，将会制定标准开发组织联络计划，这将确保已经建立联络的各标准开发组织委员会和工作小组进行有效交流，并促进多边沟通，“从而可以加强和传达标准开发组织成员之间的共识，强调与标准开发组织分享的重要性。”

同时也担任IMDRF标准工作小组主席的Colburn表示，IMDRF管理委员会正在对新工作项提案进行审议。在IMDRF-DITTA研讨会上，新工作项提案得到了其他多个国家的支持，鼓励与标准开发组织建立牢固且不断发展的联系。

针对标准开发组织联络计划提出的新工作项提案获得了DITTA以及IEC和ISO的支持，ISO/TC 210委员会主席Peter Linders指出，“很显然，IEC和ISO需要的是一种‘标准方法'。”为了落实IMDRF与ISO和IEC之间的联络，Linders赞成三个关键要素：新工作项提案、利益相关方代表和召集人。Linders表示，新工作项提案反映了对预期可交付成果的清晰愿景，有充分的理由做出努力，并且对所需时间的考虑是比较现实的。他建议采用经过多重考量的IMDRF“基本原则”。

成立IMDRF标准工作小组的目的是在地区和国家层面加强医疗器械法规统一方法标准的使用。

IMDRF标准工作小组由IMDRF所有10个监管机构、DITTA和全球医疗技术联盟（GMTA）组成，其工作旨在减轻由满足或执行既定监管要求所带来的负担。

通过采用这类标准，为制造商能够满足多个司法管辖区某些领域的要求提供了契机。通过标准化符合性评定，监管者可以借助标准实现高效审查。对于标准开发组织而言，其好处在于可以在更大程度上确保得到监管机构的认可。

为了协调监管机构采用标准的方法，IMDRF标准工作小组的当前目标包括加强监管机构对标准开发流程的影响，以及对医疗器械监管审查中采用标准的方法进行分析。这项协调工作的基础涉及制定监管等级标准方面的建议。去年11月，在一份最终技术文件中，向监管机构和标准开发组织提出了一些新的建议。

“标准在医疗器械整个生命周期（设计、生产、生产后以及监管）中发挥着重要作用，”CDRH国际事务副主任Melissa Torres说。”

IMDRF标准工作小组目前的工作项旨在，通过对认可和使用政策进行比较并制定一份普遍认可的标准清单，来协调监管机构对标准的采用情况。

Colburn表示，“初步分析结果表明，各监管机构广泛采用标准，但其政策和计划不一：主要在于监管机构采用标准的方法不同。”他补充说，工作小组关于监管机构标准采用的调查结果报告，将于9月提交给IMDRF管理委员会。

IMDRF-DITTA研讨会期间分享的初步结果指出了IMDRF监管机构在如何采用标准方面的其他挑战，包括对公认标准清单进行更新的频率存在差异。

Linders还概述了国际医疗器械质量管理体系标准（即ISO 13485）的未来，上个月医疗器械行业刚刚完成了向修订版ISO 13485: 2016的过渡。ISO 13485: 2016标准将在下个月进行系统复审，以符合ISO高级结构（HLS）。原定于2月份实施的系统复审先是因为IMDRF医疗器械单一审核程序（MDSAP）被搁置，随后由于对术语和定义实施修订可能产生的连锁反应再次被推迟。相关人士认为，在过渡期的最后期限内进行审查会引发许多问题。

Linders表示，即将进行的ISO 13485: 2016高级结构修订产生实质性变化的可能性微乎其微。完成高级结构修订的ISO 13485: 2016标准的预定于2022年生效。此外,Linders还对ISO 1471:2019变更进行了概述，使风险管理框架变得标准化。

英文原文

CDRH Proposes New IMDRF Work Item on Standards

Medical device industry delegates and global regulatory authorities are looking to further support their collaboration with standards development organizations (SDOs) through a newly proposed liaison program.

Scott Colburn, director of the standards program at the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), pitched an International Medical Device Regulators Forum (IMDRF) new work item (NWI) during a workshop hosted by the IMDRF standards working group and the Global Diagnostic Imaging, Healthcare IT and Radiation Therapy Trade Association (DITTA) last week in Russia.

The NWI proposal (NWIP) seeks to set new parameters for IMDRF to serve as liaison to the International Electrotechnical Commission (IEC) and the International Organization for Standardization (ISO). It comes after IMDRF became liaison to ISO TC210—the working group on ISO 13485—and to IEC TC 62 last year.

According to Colburn, the SDO liaison program that would be established if the NWIP is granted by the IMDRF management committee (MC) would allow for effective representation in liaised SDO committees and working groups and support multilateral communications to “foster and convey consensus among IMDRF members to establish positions of regulatory importance to share with SDOs.”

Colburn, who also serves as chair of the IMDRF standards working group, reported the NWIP as being under the IMDRF MC’s consideration. The NWIP drew support from several others at the IMDRF-DITTA workshop in Russia to encourage strong and growing relations with SDOs.

The NWIP for an SDO liaison program garnered the support of DITTA as well as that of IEC and ISO, with ISO/TC 210 committee chair Peter Linders noting that “obviously, IEC and ISO demand a ‘standard approach.’” To operationalize the IMDRF liaison to ISO and IEC, Linders argued for three critical elements: the NWIP, stakeholder representation and a convener. The NWIP “reflects clear vision of [the] intended deliverable, has solid justification for the effort to be made” and is “realistic about time needed,” according to Linders. He recommended using select IMDRF “essential principles.”

The IMDRF standards working group was established with the goal of enhancing the use of standards for harmonized approaches to medical device regulations on a regional and national level.

The efforts of the IMDRF standards working group, which is comprised of all 10 IMDRF regulators, DITTA and the Global Medical Technology Alliance, are aimed at reducing the burden associated with meeting or enforcing set regulatory requirements.

The use of standards provides an opportunity for manufacturers to seek compliance in certain areas across multiple jurisdictions. Regulators can leverage standards to achieve review efficiencies using standardized conformance assessments. For SDOs, benefits relate to greater assurance of recognition by regulators.

To harmonize regulators’ approaches to the use of standards, current objectives of the IMDRF standards working group include increased and enhanced regulator influence in standards development processes and analyzing approaches to using standards in regulatory reviews of medical devices. A cornerstone of this harmonization work involves recommendations for developing standards of regulatory grade. New recommendations to regulators and SDOs were established last November in a final technical document.

“Standards play a significant role in the design, production, post-production and regulation of medical devices throughout their lifecycle,” said CDRH associate director for international affairs Melissa Torres.

The IMDRF standards working group’s current work item seeks to harmonize regulatory authorities’ (RAs) use of standards by comparing recognition and use policies and developing a checklist of commonly recognized standards.

“Preliminary analysis shows broad commitment to use of standards but differing policies and programs: mostly in how RAs’ approaches are,” Colburn reported. He added that a report on results from the working group’s survey on RAs’ use of standards will be submitted to the IMDRF MC in September.

The preliminary results shared during the IMDRF-DITTA workshop pointed to other challenges in how IMDRF RAs use standards, including varying frequency of updates to lists of recognized standards.

Linders also provided an overview on the future of the international standard for medical device quality management systems, known as ISO 13485, for which industry completed a transition to the revised 13485:2016 last month. The 2016 version of the standard is to undergo a systematic review for conformity to the ISO High Level Structure (HLS) next month. The systematic review was delayed from its original February schedule, following pushback from the IMDRF Medical Device Single Audit Program, due to potential ripple effects of revisions to terms and definitions. It would been problematic for the review to occur during transitional deadlines, the consortium argued.

The likelihood of the upcoming 13485:2016 HLS revision resulting in “substantive change is minimal,” said Linders. The target effective date for the HLS-revised standard is 2022. Linders provided an additional overview of changes to ISO 1471:2019, which standardizes a risk management framework.

来源：RAPS

原文链接：https://www.raps.org/news-and-articles/news-articles/2019/3/cdrh-proposes-new-imdrf-work-item-on-standards

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