RegsWizard - Simplifying the Complex World of Medical Device Regulation

RegsWizard - 简化医疗器械监管的复杂世界

• 批准号: 10020764
• 金额: $ 50.04万
• 依托单位: ORCHA HEALTH LTD
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2021
• 资助国家: 英国
• 起止时间: 2021 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=10020764
• 关键词: RegsWizard; Simplifying; Complex; World; Medical

**The** **Challenge**The world of Medical Device Regulation ("MDRegs") is extremely complex and difficult to navigate. Even seemingly simple questions like, "is my product a Medical Device ("MD")" are riven with interpretive complexity and nuance. This is even more the case in the emerging world of Digital Health which is contributing significantly to the increase in the number of Software as a Medical Device ("SAMD").The guidance available to product owners ("Product-Owners") looking to navigate this space, is limited to generic 'static' advice and information provided by relevant industry bodies (i.e. regulators or approved assessment bodies like BSI/TuvSud) or very specialist consultancy support from rare and costly experts.This limited guidance is exacerbated by a lack of transparency or clarity over the precise interpretations to be applied - particularly in the SAMD space - and the associated requirements that Product-Owners need to take into account to ensure compliance.The full impact of this is to be found in the raft of products that do not - intentionally or otherwise - meet these key regulatory requirements (a recent ORCHA survey illustrated a potential none compliance rate in the Digital health space of over 50%), but also huge inefficiency and delay for those Product-Owners who attempt to navigate through the complexities.**The Concept**This project brings together a hugely complimentary and multi-disciplinary team, lead by ORCHA to address this critical issue through the development of an intuitive, interactive and intelligent tool (the "RegsWizard"), that can provide Product-Owners with tailored, personalised and reliable advice and guidance at a fraction of the cost of traditional 'expert' consultancies.The RegsWizard is a ground breaking concept in this space - although ORCHA have developed similar constructs in the broader Digital health regulatory environment. It will revolutionise the navigation of products through the MDRegs landscape and ensure that reliable advice and guidance is available to all Product-Owners at an affordable price.At the heart of the RegsWizard concept is an intuitive interactive tool that enables Product-Owners to accurately identify the likely status of their product under MDRegs in the UK (UKCA mark) and EU (MDR CE mark) and which generates a tailored checklist of compliance requirements that flow from that status and which will be necessary to meet the demands of the relevant regime. The RegsWizard will also identify or map to relevant externally maintained Nomenclatures with a specific focus on SNOMED and GMDN.

* 挑战 ** 医疗器械法规（“MDRegs”）的世界极其复杂，难以驾驭。即使是看似简单的问题，如“我的产品是医疗器械（“MD”）”，也充满了解释的复杂性和细微差别。在新兴的数字健康领域，情况更是如此，数字健康对作为医疗器械的软件（“SAMD”）数量的增加做出了重大贡献。（“产品所有者”）希望在这个领域中导航，仅限于相关行业机构提供的一般“静态”建议和信息（即监管机构或批准的评估机构，如BSI/TuvSud）或来自罕见且昂贵的专家的非常专业的咨询支持。这种有限的指导由于对所应用的精确解释缺乏透明度或清晰度而加剧-特别是在SAMD领域-以及产品所有者为确保合规性而需要考虑的相关要求。这一点的全部影响将在有意或无意地不符合这些关键监管要求的大量产品中发现（最近的一项ORCHA调查显示，数字健康领域的潜在不遵守率超过50%），但对于那些试图通过复杂性导航的产品所有者来说，也是巨大的效率和延迟。概念 ** 这个项目汇集了一个巨大的互补和多学科的团队，由ORCHA领导，通过开发一个直观，互动和智能的工具来解决这个关键问题（“RegsWizard”），可以为产品所有者提供定制的，个性化和可靠的建议和指导的一小部分成本的传统'专家'咨询。RegsWizard是一个突破性的概念，在这个领域-尽管ORCHA已经在更广泛的数字健康监管环境中开发了类似的结构。它将彻底改变产品在MDRegs环境中的导航，并确保以合理的价格向所有产品所有者提供可靠的建议和指导。RegsWizard概念的核心是一个直观的交互式工具，使产品所有者能够准确地识别其产品在英国MDRegs下的可能状态（UKCA标志）和欧盟（MDR CE标志），并生成一个量身定制的合规要求清单，这些要求来自该状态，并且是满足相关制度要求所必需的。RegsWizard还将识别或映射到外部维护的相关术语，特别关注SNOMED和GMDN。