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欧盟关于医疗器械和体外诊断医疗器械法规发布 ---医疗器械法规和标准的作用

发布时间: 2017-09-28 10:24:02   审校:睿智   浏览次数:
来源:https://www.cencenelec.eu/news/brief_news/Pages/TN-2017-030.aspx  

随着欧盟委员会于2017年5月5日发布新的医疗器械和体外诊断医疗器械法规(MDR和IVDR),欧洲法规框架的长期修订工作也告一段落。由于这些法规带来的种种变化,法规会对该行业的各种利益相关方构成新的挑战。法规扩大了产品范围,对临床评估、临床调查、强制性唯一器械标识(UDI)机制以及欧洲公告机构加强上市后监督都提出了更为严格的要求。 此外,IVDR还在医疗器械全球协调工作组的分类规则的基础上提出了新的风险规则分类系统,该系统首次将患者的影响考虑在内。

这些法规确认了标准化在医疗器械领域的重要作用。通过遵守协调标准,制造商可以使自身符合法规的一般安全、性能、质量和风险管理方面要求,从而进入欧洲市场。除了标准化外,这些法规还授权欧盟委员会发布代表最先进技术的共同技术规范,并将其作为产品评估过程的一部分。 然而,关于共同规范的制定及其与协调标准的共存,仍然存在一些问题。

鉴于新的法规框架的复杂性,其提出的变化范围以及较短的过渡期,应提供开放空间,用于讨论和交换有关新法规和未来方向的信息和想法。这是“关于医疗器械和相关标准的新规定:确保成功过渡”的研讨会的目标,该研讨会由CEN和CENELEC组织,将于2017年9月21日举行。研讨会将重点关注标准化及其在支持新法规中的作用、法规协调标准的未来走向以及为了欧洲公民和产业的利益而确保顺利过渡的要求。

 

The medical devices’ Regulations and the role of Standards

With the new medical devices and in-vitro diagnostic medical devices Regulations (MDR and IVDR) published on 5 May 2017 by the European Commission, the long process of revising the European regulatory framework has ended. The Regulations pose new challenges to the various stakeholders involved in the sector due to the changes that they have introduced. They have expanded the scope of products, there are more rigorous requirements for clinical evaluations as well as changes to clinical investigations, mandatory unique device identification (UDI) mechanisms, and increased post-market oversight by European Notified Bodies. In addition, the IVDR introduces a new risk-rule classification system based on the Global Harmonization Task Force’s rules for classification, which considers patient impact for the first time.

The Regulations recognise the important role of standardisation in the field of medical devices. By complying with harmonised standards, manufacturers may demonstrate conformity with the general safety, performance, quality and risk management requirements of the Regulations, and thereby gain access to the European market. In addition to standardisation, the Regulations authorise the European Commission to publish common technical specifications that will represent state-of-the art and will be part of the products’ evaluation process. Several questions remain open, however, regarding the development of the common specifications and their co-existence with harmonised standards.

Given the complexity of the new regulatory framework, the scope of the changes it has introduced, and the short timeframe for the transition period, it is important to provide an open space for discussion and exchange of information and ideas regarding the new Regulations and the way forward. This is the objective of the Seminar on ‘The new regulations on medical devices and related standards: ensuring a successful transition’, which is organised by CEN and CENELEC and will take place on 21 September 2017. The focus of the seminar will be on standardization and its role in supporting the new Regulations, the future of harmonised standards under the Regulations, and the need to ensure a smooth and successful transition for the benefit of European citizens and industry.

Consult the agenda of the seminar and register before 19 September.

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