HISTORY & IMPACT HIGHLIGHTS

PHASE 1

DISCOVERY PHASE 1

The Discovery Phase of the CLEARED CERSI IVD Network laid the foundations for advancing regulatory science in diagnostic technologies. Led by University College London, with partners Psephos Biomedica, Insightful Health Ltd, and Act-IVD, and supported by the MHRA and Innovate UK, this phase identified the key regulatory challenges facing the development of innovative diagnostics.

Through collaboration with regulators, industry, and academia, the team focused on two priorities: improving evidence-based regulatory documentation and advancing post-market surveillance (PMS) methods. Building on an established strong partnership with the MHRA, the phase developed early frameworks and modelling tools, and confirmed the need for a national network to strengthen diagnostic regulation through shared expertise and innovation.

IMPACT OF DISCOVERY PHASE 1

The Discovery Phase of the CLEARED CERSI establishing the foundation for advancing regulatory science in diagnostics across the UK. The consortium led by University College London with Psephos Biomedica, Insightful Health Limited and AVCT-IVD, working closely with the MHRA to identify priority areas for regulatory innovation: evidence-based regulatory documentation (WP1) and post-market surveillance (PMS) (WP2).

Through surveys, interviews, and expert engagement, CLEARED CERSI gathered insights from regulators, industry, clinicians, statisticians, and health economists, generating a robust evidence base to guide the Implementation Phase. Key outputs included:

A validated Regulatory Document Framework informed by stakeholder feedback from over 80 global respondents.
Initial statistical models for PMS, exploring performance monitoring and real-world data use.
Strengthened collaboration with MHRA, BIVDA, ISO, and WHO, aligning CLEARED CERSI with UK and international priorities.
This phase delivered a clear roadmap for implementation, demonstrating how CLEARED CERSI can enhance regulatory methods, reduce uncertainty for innovators, and support the safe, effective translation of new diagnostic technologies into healthcare.

CLEARED CERSI for IVDs: Problem Statement

Regulatory requirements for IVDs have increased for both UK (MHRA) and EU (IVDR):

New requirements span clinical evidence and post market surveillance (PMS)
Requirements are still evolving

Uncertainty in state of the art and acceptable best practice:

Lack of detailed methods is hindering innovation and regulatory conformity assessment
Rapid change has led to gaps in knowledge, skills and training
Novel technologies present challenges potentially requiring for new methodological approaches

Dissemination of state of the art practice methods and guidance are needed for:

Appropriate generation and integration of clinical evidence in regulatory documents
Methodological approaches in PMS
Networking and sharing of knowledge, skills and training

The Evolving Landscape of IVD Regulation

Regulatory requirements for In-Vitro Diagnostics (IVDs) have expanded significantly across both the UK (MHRA) and EU (IVDR) frameworks. These new requirements now place greater emphasis on clinical evidence and post-market surveillance (PMS), while the expectations and standards continue to evolve.

This changing landscape has created uncertainty around what constitutes state-of-the-art practice and acceptable regulatory approaches, with a lack of detailed methodological guidance often hindering both innovation and conformity assessment. At the same time, rapid regulatory change has led to gaps in knowledge, skills, and training, particularly in the evaluation of novel and emerging technologies such as AI-enabled and digital diagnostics.

The CLEARED CERSI IVD Network addresses these challenges by promoting the dissemination of best-practice methods and guidance, focusing on:

The appropriate generation and integration of clinical evidence in regulatory documentation.
The development of methodological approaches for PMS.
Networking, knowledge-sharing, and training to strengthen regulatory science across the UK and internationally.