Tangible Impact
The insight and strategic guidance provided by HealthTech Enterprise enabled the senior management team at MultiplAI to make informed decisions about their regulatory approach, product 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 navigate the key steps required to obtain a UKCA mark, CE mark, and FDA approval. This insight was invaluable and helped us refine and confirm our market entry strategy.”Mark Paul Ramondt, Co-Founder, MultiplAI
Assessing the Challenge
MultiplAI is developing an RNA-based liquid biopsy designed to screen for and predict cardiovascular disease by assessing the presence of atherosclerotic plaques in the blood. Their innovation is intended as a screening service for coronary heart disease, offering insights into the current disease status and assessing future risks of cardiovascular or cerebrovascular events.
MultiplAI sought to gain a comprehensive understanding of the regulatory pathways for their liquid biopsy innovation in the UK, EU, and US. This knowledge would help them align their regulatory approval priorities with their strategic decisions for launching in different markets.
Tailored Approach
We collaborated with MultiplAI to define the intended purpose of their liquid biopsy, considering medical applications, patient demographics, specific disease areas, and diagnosis stages.
Our team conducted a detailed review of key guidance from the MHRA, EU, and FDA to determine the product’s classification as a medical device under UK MDR 2002, the In Vitro Medical Devices Regulation 2017/746/EU, and FDA regulations.
For each territory, we:
- Identified key stakeholders and their roles in the regulatory process.
- Clarified the conformity assessment requirements necessary for market approval.
- Outlined the steps required to meet UKCA, CE, and FDA approval standards.
The final 50-page report detailed essential regulatory activities, including:
- Preparation of technical documentation to demonstrate compliance.
- Implementation of a Quality Management System (QMS).
- Development of a Post-Market Surveillance Plan.
- Requirements for device labelling and instructions for use.
Additionally, the report provided an overview of the Clinical Laboratory Improvement Amendments (CLIA) approval process for ensuring laboratory testing quality and accreditation in the US.
