OBJECTIVES

Our Goals

Building on our Discovery phase initiation of an In-Vitro-Diagnostic (IVD) CERSI virtual network in Regulatory Science in the priority area of IVD diagnostic tests, urgently needed to support new MHRA regulations for IVD and other diagnostic medical devices. This supports the key goals in diagnostic regulation through innovative regulatory science to:

ensure patient and consumer safety
support the policy makers including the MHRA in effective and efficient regulation
support UK industry and manufacturers to efficiently bring tests to market use in UK
enable UK leadership and international partnerships.

Our Approach

Our diagnostic test regulatory science approach encompasses a structural framework common to the priority areas:

IVD regulation
Diagnostic devices including artificial intelligence (AI) and software
Diagnostic medical technologies (eg Xray, MRI) Diagnostic test regulation is a key area identified in multiple strategic UK government documents including:
- UK Science and Technology Framework →
  www.gov.uk/government/publications/uk-science-andtechnology-framework
- Pro-innovation Regulation of Technologies Revie →
  www.gov.uk/government/collections/pro-innovationregulation-of-technologies-review
- Regulatory Horizons Council (RHC) report on medical devices regulation →
  assets.publishing.service.gov.uk/media/611d11f1d3bf7f63aeb66cb3/rhcmedical-report.pdf

Our Unique Contribution

Our network focuses on IVD tests across the range of technologies, and brings together expertise and partnership in diagnostic regulation with the statistical design of diagnostic clinical performance evaluation. These are scarce skillsets critically important cornerstones for building a network to collaborate and partner with regulators, industry, people living with disease and clinical end users of tests.

Our focus is important and innovative, due to the paucity of regulatory research on diagnosis. The regulatory science priorities we propose fill a current (global) research gap. None of the areas in our proposals are addressed in the upcoming projects from the three FDA sponsored Centres of excellence of regulatory science and innovation (CERSI):

cersi.umd.edu/projects →

pharm.ucsf.edu/cersi/research#medicaldevices →

publichealth.jhu.edu/center-of-excellence-in-regulatory-science-andinnovation →