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【奥译言】欧盟医疗器械新规

阅读: 2017年05月17日


简 介

2017年5月5日,欧盟公报(OJEU)发布了欧盟新医疗器械法规(MDR)和体外诊断医疗器械法规(IVDR)。MDR将于2020年5月26日起施行。IVDR将于2022年5月26日起施行。

新法规的发布标志着对整个欧盟,乃至其他地区的医疗器械进行全面改革。在某种程度上,这是对诸如乳房植入物,金属人工髋关节以及起搏器等丑闻的回应,反映了现有监管系统的弱点。MDR和IVDR发布的目的,旨在弥补这些监管缺失,并建立更加强大,透明,可预测性以及可持续性的监管架构,确保医疗器械达到更高的安全水平。所有在欧盟地区经营医疗器械的企业,都会感受到新法规带来的影响,但法规对企业的影响是取决于医疗器械产品组合中的风险状况,特别是需要进行新的临床研究的医疗器械。尚未分析其体系、产品组合和通过公告机构的可行性与新法规的差距的医疗器械制造商,现在需要着手开展了。利益攸关方的组织及成员国当局将需要多地关注新法规,因为欧盟委员会将会起草和发布80多项实施和授权行为。


直接影响

准备上市后的临床要求。在过渡期结束前,所有医疗器械制造商的上市后监督系统都必须包括上市后临床跟踪指南(PMCF)(或对于IVD医疗器械,进行上市后市场绩效跟踪(PMPF)),以达到不断更新医疗器械的临床评估,这反应出目前医疗器械引导原则并不具有约束力。对于可植入和三类医疗器械,医疗器械制造商必须制定一个“安全和临床有效性总结报告”,这将由公告机构验证并向大众公开。制造商们必须根据新的MDR / IVDR审查其系统,实施所有新要求并对员工进行培训。

期待加强审查和监督。根据MDR/IVDR规定,所有公告机构将会被重新指定,以及当公告机构对制造商,包括分包商和供应商,开展飞行检查时,所有公告机构将需要有规范的书面程序。这些义务已经在2017年2月16日欧盟法院裁定之后成为讨论热点,欧盟法院还声明,公告机构不具有进行飞行检查的一般义务。

对于某些高风险医疗器械,MDR / IVDR引入了审查机制,将对公告机构进行合格评估。公告机构将会通知主管机构,对高风险医疗器械颁发生产许可证书,以及基于合理的顾虑,对于任何医疗器械的安全和性能,主管机构(或欧盟委员会)可以向专家小组提出进一步科学咨询的要求。

准备新的产品组合和分类规则。新法规的颁布,使得许多医疗器械定义发生改变。制造商将清洁和消毒用品的某些产品组,定义为非医疗目的,但其功能方面与医疗器械相似的,将被纳入新法规的范围。同时,医疗器械配件的定义也被扩大;定制器械将不再包括工业大批量制造的医疗器械。某些风险较高的医疗器械已经从新被分类为三类医疗器械,包括驱动医疗器械或影响医疗器械使用的App。对于IVD的医疗器械已经引入了全新的分类规则,将IVD的医疗器械分类为A至D类。医疗器械制造商必须重新评估所有器械,并确定其使用的规则。不同欧盟成员国不同的分类决定将会降低其风险,因为欧盟委员会将授予新的权力,来确定特定的产品是否属于MDR / IVDR的范围。

增强可追溯性要求。不具约束力的2013/172/EU号欧盟建议已经被纳入MDR/IVDR。建议要求,唯一识别标识(UDI)必须与所有的医疗器械一起贴附并与之配套,使其可以识别并且可以通过供应链进行跟踪。包括分销商和进口商在内的每一个供应链参与者,都将拥有监管的责任。需要对协议进行评估与修订,以及在平行贸易中加强相关的竞争法合规工作。

大量的UDI数据,如警惕和上市后监督,将被纳入欧洲医疗器械数据库(EUDAMED),并且大部分信息将向公众公开,以供利益攸关方更好地作出决策。

授权代表的共同法律责任。尽管事实上,授权代表无法对可能导致产生法律责任的因素进行控制,但新法规引入了对授权代表与医疗器械制造商,关于有缺陷的医疗器械,具有同等和个别连带责任。因此,可以预测的是,责任条款的有效性将被国家法院所援引。同时,对于在欧盟国家没有设立机构的数千家医疗器械制造商,现存的合同将需要被审查。

未来趋势


欧盟委员会将需要通过80多项实施和授权行为,例如关于临床评估要求(实质等同器械),UDI法规(可能影响标签变更),以及符合性评定程序。贸易协会预期将在这些行为方面发挥积极作用。

鉴于和以往相比,目前医疗器械数量明显较多(IVD医疗器械大约占据80%的市场份额),因此需要公告机构的介入,而且在不久的将来,公告机构对表现良好和受过培训的人才需求将会加大。由于国家主管部门正在争取相同的人力资源,以应对新法规的复杂性,因此预期,在MDR/IVDR新法规的制度下,重新指定公告机构将会被延迟,或者公告机构的数量将会有所下降。医疗器械制造商必须确保其原公告机构将会被重新指定,或尽快寻找会被重新指定的公告机构。

MDR/IVDR规定,所有医疗器械都需要被重新认证。通过自我认证的医疗器械,需要分别在2020年5月26日或2022年5月26日前完成重新认证。对于其他所有医疗器械,制造商可以使用现有的认证至2024年5月27日。很重要的一点,MDR/IVDR规定,在MDR / IVDR颁发证书之前,医疗器械制造商不可以对器械的设计和预期目的有明显的变化。客户需求和公告机构的有效性也许为医疗器械的重新认证提供便捷。


总 结

本文章涵盖的MDR/IVDR大部分的关键要求,但仍有部分要求没有提及。医疗器械制造商可以通过尽早完成差距分析和获取可靠资源,并积极履行80多项实施和授权行为,将有助企业获得竞争优势。


英语原文  


New EU Medical Device Regulations - Immediate Impact and Moving Targets

Introduction

The new EU Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) werepublished on May 5, 2017 in the Official Journal of the EU. The MDR will applyfrom May 26, 2020. The IVDR will apply from May 26, 2022.

The new regime marks a major overhaul of the medical deviceslandscape that will resonate across the EU and beyond. It is, in part, aresponse to scandals surrounding PIP breast implants, metal-on-metal hipreplacements and pacemakers, which highlighted weaknesses and gaps in theexisting system. The MDR and IVDR aim to fill these gaps and to establish amore robust, transparent, predictable and sustainable regulatory framework toensure a higher level of safety. The impact of the new regime will be felt byevery medical device company operating in the EU, but the intensity will dependon the risk profile of the devices in its portfolio and, in particular, on theneed to do new clinical studies. Manufacturers that have not yet carried out agap analysis of their systems, product portfolio and Notified Body availabilityshould start now. All stakeholders will have to deal with moving targets, giventhat over 80 delegated and implementing acts must still be drafted andpublished by the European Commission.

ImmediateImpact

Prepare for post-market clinical requirements. By the end of the transition period, every manufacturer’spost market surveillance system must include a post-market clinical follow-up(PMCF) (or, for IVD medical devices, a post-market performance follow-up(PMPF)) to continuously update the clinical evaluation of the device,reflecting current non-binding MedDev guidance. For implantable and class IIIdevices, manufacturers must draw up a “summary of safety and clinicalperformance” which will be validated by a Notified Body and made publicallyavailable. Manufacturers must review their systems against the new MDR/IVDR,implement all new requirements and train their staff.

Expect enhanced scrutiny and surveillance. All Notified Bodies will have to be re-designated underthe MDR/IVDR and will, e.g., be required to have documented proceduresregarding unannounced on-site audits of manufacturers and, whenapplicable, of subcontractors and suppliers. These obligations were already inthe spotlight following a February 16, 2017 Court of Justice of the EuropeanUnion ruling which stated that Notified Bodies are not under a generalobligation to carry out unannounced inspections1.

For certain high-risk medical devices, the MDR/IVDR introduce amechanism for scrutiny of the Notified Body’s conformity assessment: NotifiedBodies will notify competent authorities of certificates granted for such highrisk devices and the competent authority (and, where applicable, the EuropeanCommission) may, based on reasonable concerns, apply further procedures orrequest scientific advice from expert panels in relation to the safety andperformance of any device. Manufacturers must have sufficient resources toaccommodate such requests.

Prepare for new product groups and classification rules. Under the new regime, many definitions will change, e.g.,certain groups of products for which a manufacturer claims only an aesthetic oranother non-medical (i.e., cleaning or sterilization) purpose but which aresimilar to medical devices have been included into the scope of the new regime.Also, the definition of accessories has been enlarged; and the exception forcustom-made devices will no longer include devices which are mass-produced bymeans of industrial manufacturing processes. Certain riskier devices (includingsoftware which drives that device or influences the use of that device) havebeen re-classified as class III devices. For IVD medical devices, entirely newclassification rules have been introduced, categorizing IVD medical devicesinto classes A through D. Manufacturers must (re-)assess all their devices anddetermine the applicable rules. The risk of different classification decisionsby different EU Member States will be reduced, as the Commission is given newpowers to determine whether a specific product should fall within the scope ofthe MDR/IVDR.

Enhanced traceability requirements. The requirements of the non-binding Commission Recommendation2013/172/EU have been included in the MDR/IVDR. Requirements include a UniqueDevice Identification (UDI) which must be affixed to and provided together withany medical device, allowing it to be identified and traced through the supplychain. Each participant in the supply chain, including distributors andimporters, will have their own regulatory responsibilities. This will requirereview and revision of agreements, as well as increased competition lawcompliance efforts in relation to parallel trade.

The UDI, along with a significant amount of data such as onvigilance and post-market surveillance, will be entered into an enhancedEuropean Databank on Medical Devices (EUDAMED) and made publicly available toenable better informed decisions of stakeholders.

Joint legal liability for Authorized Representatives. The new regime introduces legal liability of the AuthorizedRepresentative for defective devices, jointly and severally with themanufacturer, despite the fact that Authorized Representatives are notpermitted to control the parameters that could lead to liability. Thus, it canbe expected that the validity of the liability provisions will be invokedbefore national courts. In the meantime, existing contracts will need to bereviewed for thousands of manufacturers that do not have an establishment inthe EU.

MovingTargets

The European Commission will need to adopt more than 80 delegated and implementingacts, e.g., with regard to clinical evaluation requirements (e.g.,demonstration of equivalence), UDI rules (which may affect labelling changes)and conformity assessment procedures. Trade associations are expected to playan active role in shaping these acts.

Given that a significantly larger number of devices than before(e.g., approximately 80 percent of IVD medical devices) will now require theinvolvement of a Notified Body, the latter will likely require more and bettertrained staff. As national competent authorities are competing for the samepersonnel resources to be able to tackle the complexities ofthe new regime, a delay in re-designation of Notified Bodies under theMDR/IVDR, or even a (further) drop in the total number of Notified Bodies isexpected. Medical device manufacturers must ensure now that their Notified Bodywill be re-designated — or begin the process of switching to a Notified Bodythat will be re-designated as soon as possible.

The MDR/IVDR provides that all devices will have to be re-certified.Self-certified medical devices will need to be re-certified by May 26, 2020 or2022, respectively. For all other devices, manufacturers can rely on existingcertifications until 27 May 2024. Importantly, manufacturers that do so cannot make significantchanges in the design or intended purpose until the issuanceof a certificate under the MDR/IVDR. Customer demand and Notified Bodyavailability may also provide incentives to re-certify earlier rather thanlater.

Conclusion

This Update covers key requirements of the new MDR and IVDR, butthere are many more. Competitive advantages can be obtained by companies thatcomplete their gap analyses and secure resources early, and by activelyfollowing the 80+ acts that will give further shape to the new regime.




内容来自: LEXOLOGY

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