Accelerating medical technology innovation: data driven augmented regulatory conformity assessment

欧盟和英国市场上有超过60万种独特的医疗设备，从医院病床到核磁共振扫描仪，体外诊断，医疗设备软件，输液泵，脑刺激器和髋关节置换术。医疗设备是根据与其相关的风险进行分类的。风险最低的产品，如处方眼镜，属于第一类，企业可以自行认证产品并将其投放市场。高风险医疗器械被分为IIa类、IIb类或III类，属于这些类别的产品需要正式的合格评定，由欧盟的公告机构（NB）或英国的英国批准机构（UKAB）进行。医疗器械制造商必须向NB或UKAB提交一份技术文件，其中包含制造商如何遵守法规要求的证据。该文件可能包含10,000页高度复杂的信息，由人员手动审查，然后确定是否可以授予CE标志或UKCA标志。新的欧盟医疗器械立法大大增加了对公告机构的法律要求，并导致从55个减少到31个。训练有素的新英格兰员工也严重短缺，可能需要5年以上的时间来培养人才。对于行业来说，这意味着NB可能需要6个多月的时间才能接受，随后是18个月的合格评估过程（是旧指令的两倍），并增加了大约6万英镑的成本。MedTech Europe估计，由于成本和时间的增加，27%的产品将被从市场上撤下。我们将开发一个独特的数据驱动平台，以支持技术文件审查流程，这将彻底改变国家统计局进行合格评定的方式。技术文件将被输入系统，该系统将接受培训，以确定评估方法，并通过以逻辑和有序的方式呈现信息来增强审查（例如识别设备声明，对齐术语，例如与材料的生物相容性，以及临床研究）。这将使审稿人能够专注于关键方面，并可以缩短时间

There are more than 600,000 unique medical devices on the market in EU and UK ranging from hospital beds to MRI scanners, in-vitro diagnostics, software as a medical device, infusion pumps, brain stimulators and hip replacements.Medical devices are classified based on the risks associated with them. Lowest risk products such as prescription glasses, are Class I and businesses can self-certify their products and place them on the market.Higher risk medical devices are placed into either Class IIa, Class IIb or Class III Products that fall into these categories require formal conformity assessment which is carried out by a business called a Notified Body (NB) in EU or UK Approved Body (UKAB) in Great Britain.A medical device manufacturer must submit a technical file to the NB or UKAB that contains evidence of how the manufacturer has complied with the regulatory requirements. This file can contain 10,000 pages of highly complex information that a person manually reviews and then determines whether a CE Mark of UKCA Mark can be conferred.New EU medical device legislation has significantly increased legal requirements on Notified Bodies and led to a decrease from 55 to 31\. There is also a critical shortage of trained NB staff and it can take 5+ years to develop people.For industry this means it can take 6+ months to be taken on by a NB followed by an 18-month conformity assessment process (twice as long as under old Directives) and increased costs circa £60,000\. MedTech Europe estimate that 27% of products will be removed from the market as a direct result of increased costs and timelines.We will develop a unique data driven platform to support the technical file review process that will revolutionize how NBs undertake conformity assessment.Technical files would be fed into the system that would be trained to identify the assessment methodology and augment the review by presenting information in a logical and ordered manner (such as identifying device claims, aligning terminology such as biocompatibility with material, and clinical studies). This will enable the reviewer to focus on key aspects and could decrease timelines