MultiplAI are developing an RNA based, liquid biopsy which screens for and predicts cardiovascular disease by assessing the presence of atherosclerotic plaques in the blood.
The innovation is being developed as a service for use in screening for coronary heart disease. This will provide insight into the current status of coronary heart disease in patients, as well as assess their future risk of suffering a cardiovascular or cerebrovascular event.
The Brief
MultiplAI wanted to better understand the regulatory pathways for their liquid biopsy innovation in the UK, EU and US to help align their priorities for gaining regulatory approval with strategic decisions for launching their products in different markets.
Our Approach
We worked with MultiplAI to help them identify the intended purpose of the liquid biopsy, including whether it has a medical purpose, the types of patients, specific disease areas, diagnosis stage etc.
We examined, reviewed and summarised key guidance provided by the MHRA, EU and FDA to determine whether the innovation is a medical device, and its classification under UK MDR 2002, In Vitro Medical Devices Regulation 2017/746/EU and FDA regulations.
For each territory, we identified the key stakeholders, together with their roles and responsibilities. We also clarified the conformity assessment requirements in each territory in order to fulfil each authority’s medical device regulations and allow placement of their product on the market. The report identified and summarised the key activities required:
- Preparation of technical documentation to demonstrate conformity of the product with the requirements of the various Directives and Regulations.
- Implementation of a Quality Management System (QMS).
- Development of a Post-Market Surveillance Plan.
- Requirements for device labelling and instructions for use.
The 50 page report also provided an overview of the Clinical Laboratory Improvement Amendments (CLIA) approval process to establish quality standards for laboratory testing and the accreditation program for clinical laboratories for commercial operations in the US.
Outcomes
The report and insight enabled the senior management team at MultiplAI to make strategic decisions regarding their initial regulatory activities, and the product’s market positioning and overall value proposition.
“HealthTech Enterprise provided key regulatory support by clarifying the different routes to obtaining regulatory approval as a medical device in different territories. The report they provided summarised the specific regulatory pathways in the UK, Europe and US for our platform and helped us to navigate the key steps required to obtain a UKCA mark, CE mark and FDA approval. This insight was invaluable and helped us to refine and confirm our market entry strategy.” Mark Paul Ramondt, Co-Founder, MultiplAI
