10020764RegsWizard - Simplifying the Complex World of Medical Device RegulationClosedCollaborative R&DInnovate UK**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.