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欧盟即将发布MDR和IVDR法规

阅读: 2016年12月19日

欧盟即将发布MDR和IVDR法规


欧盟新医疗器械法规(EU-MDR)和体外诊断医疗器械法规(EU-IVDR)的立法提案获得批准后,其最终草案已于今年夏季翻译成欧盟各国语言。今年8月,发布了一份修订后的整合草案。并于10月中旬发布了另一个版本,首次微调。接下来的步骤是获得欧盟成员国关于最终草案文本翻译和法律正确性的反馈。公众意见的收集刚刚结束,目前正在对公众意见进行整理汇总并解决任何差异性问题。所以,相关工作正一步一步取得进展,并离最终发布日期越来越近。最新估计,MDR和IVDR有可能在2017年的第二季度正式发布并生效,过渡期分别为MDR发布后的3年和IVDR发布后的5年。


MDR和IVDR新法规将会使医疗器械的安全性和性能提高到一个新的水平,同时新法规的出台也是主管当局、患者和公众的强烈要求。不仅如此,新法规还拥有一个额外的实施和授权行为体系,允许立法者随着时间的推移对技术状态和正在进行的医疗改进要求进行调整。因此,新法规建立的是一种不会过时的机制。另一种这样的机制是所谓的“通用规范”系统,可以随时间的推移增加要求和政策的详细描述,以引导所有利益相关者针对上市后临床跟踪方案的具体情况在临床安全、临床表现、上市后监督和患者随访方面的最低预期。


与此同时,大家看到早期实施已经开始。医疗器械专家组会议被主管当局和公告机构之间举行的新特别会议所取代,使得成员国的共同说明和希望能与公告机构共享。同时,公告机构加强了协调,寻求关于早期说明的持续性问题的联合说明。此外,仍在继续进行的是2013年启动的公告机构重新指定程序,以便按照新要求的方向对公告机构进行严格要求。强有力的联合评估不但提高了公告机构的工作质量和一致性,而且使公告机构的范围不断缩减甚至完全关闭。目前剩下的公告机构数目为58个,但并非所有机构都通过了新的严格评估程序。


因此,从对公告机构的严格控制以及从合格评定推向合规检查来看,通常在卷宗审查和审核中发现的缺陷数量增加,而且导致缺陷的原因水平也在上升,因此审核中发现的严重不符合项大幅增加。认真的跟进和改进是必须的,同时也可能是极具挑战的,但从另一方面来说,这也有助于早日适应即将到来的新法规。


企业正在慢慢进入转型阶段,提高内部意识和承诺,并仔细增加监管合规预算。差距评估和组合分析也应该从现在开始。与其他企业的EU-MDR实施工作进度相比,如果您想了解自己所处的阶段,您可以下载EU MDR First Aid App进行查看。(2017年1月)


所有相关人员都在进行大量工作,因为大家意识到这种影响可能比预期的要大。特别是现在,大家看到在MEDDEV 2.7.1 rev.4 发布后,公告机构开始收紧对临床评估的要求,企业逐渐开始意识到他们的临床证据可能与等价贡献的纸牌屋一样脆弱。时间紧迫,需要收集自身产品在PMCF(上市后临床跟踪)模式下的临床数据。


由于过渡期的时间有限,可能需要最后一年进行公告机构评估以及对发现的不符合项采取纠正措施,剩下的时间用来获得临床数据、变更供应链、选择新的公告机构、以及应对其他耗时的变化,认识到这一点至关重要。


  英语原文  


EU MDR and EU IVDR getting closer to publication!


December 05, 2016


Following the approvals on the legislative proposals on both EU-MDR and EU-IVDR, the summer period has been utilized to translate the final draft that was agreed upon in principle into all EU languages. In August, a revised consolidated draft was released, and another version with first minor tweaks was circulated in the middle of October. The next steps was to get feedback from the EU member states on the translations and legal correctness of the final draft texts. The period of commenting has just ended now, and work is in progress to capture all and work resolve any discrepancies. So, progress is being made, and publication is getting closer to reality. Last estimates are finding Q2 2017 as likely period for formal publication, and entry into force – kicking off the transition period of 3 years for EU-MDR and 5 years for EU-IVDR.


The new Regulations will shift the landscape and will bring the safety and performance of medical devices to the next level, that also has been strongly requested by authorities, patient groups and the general public. And not only that, it also has a system of additional implementing and delegated acts that will allow the legislators to over time adjust the requirements to the state of technology and the ongoing healthcare improvements. As such it truly is built to last with future proof mechanisms in place. Another such mechanism is the system of so-called ‘common specifications’, detailed descriptions of requirements and policies that can be added over time to instruct all stakeholders on minimum expectations in terms of /html/list_1677.html safety, /html/list_1677.html performance, post market surveillance and follow up of patients in specific cases in post market /html/list_1677.html follow up protocols.


Meanwhile we see the early implementation already taking off. Medical Device Expert Group meetings make place for new ad-hoc meetings between the competent authorities and notified bodies, where the common interpretations and expectations from the member states are shared with the notified bodies. Notified bodies have meanwhile strengthened their coordination of finding joint interpretations on ongoing matters of early interpretation. Also continuing is the re-designation process that was initiated in 2013, to lift notified bodies in the direction of the new requirements. Strong joint assessments clearly improve the quality and consistency of work from notified bodies, but also continue to see notified bodies being reduced in scope, or even being closed altogether. Current number of remaining notified bodies is 58, whilst not all have gone through the new strict evaluation process.


As a result, from the stricter control on notified bodies, and the push away from conformity assessment to compliance inspection, typically the number of deficiencies identified in dossier reviews and audits go up, and also the level attributed to them is increasing, so numbers of major non-conformities found in audits see a dramatic increase. Serious follow up and improvements are required, which might be challenging, but on the other hand are also helpful to get into early compliance with the upcoming legislation.


Companies slowly move into transitioning phase, raising internal awareness and commitment, and carefully increasing budget for regulatory compliance. Gap assessments and portfolio analysis should be starting by now. If you wish to verify what stage you are in compared to others working on their EU-MDR implementation, you should check out our EU MDR First Aid app. (available January 2017)


A lot of work at hand for all involved, as we realize the impact might be even bigger than anticipated. Especially now that we see notified bodies tightening the reigns on the /html/list_1677.html evaluation requirements following the release of MEDDEV 2.7.1 rev.4, companies increasingly realize their /html/list_1677.html evidence might resemble too much the card house of stapled equivalence contributions. Time is there to urgently collect /html/list_1677.html data on one’s own products in PMCF mode.


With the limited time available for transitioning, realizing the last year might be needed for notified body assessments, and corrective actions on non-conformities found, the time left to get /html/list_1677.html data in, or to make for example changes in the supply chain, select a new notified body, or other time consuming changes, is becoming critical.




内容来自:Qserve regulatory Blog

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