Bringing new diagnostic tests from the lab to the clinic
- Jun 20
- 1 min read
Bringing new diagnostic tests from the lab to the clinic: why regulation matters. 🧪 -->🏥
As the UK reforms its medical device and in vitro diagnostic (IVD) regulations through the draft Medical Devices (Amendment) Regulations 2026, implementation will be just as important as the legislation itself.
I've summarised these issues and recommendations in a new policy briefing and would welcome discussion with policymakers, regulators, clinicians, industry partners, and fellow researchers working in diagnostics and medical devices.
In our research group at the School of Engineering at Lancaster University, we develop electrochemical biosensors that can measure clinically important molecules from a small sample, an alternative to laboratory testing. There is an opportunity to support innovation while maintaining patient safety. Key priorities include:
✔️ Expanding approved-body capacity for diagnostics
 ✔️ Ensuring regulatory costs do not disproportionately affect university innovators and spin-outs
 ✔️ Maintaining proportionate pathways for lower-risk diagnostics
 ✔️ Providing clear evidence requirements and realistic timelines
 ✔️ Creating early regulatory engagement routes for academic developers
The goal is simple: Ensure that innovative diagnostics developed in UK laboratories can reach patients efficiently, safely, and predictably.
#MedicalDevices #Diagnostics #IVD #HealthcareInnovation #MedTech #Policy #Regulation #PointOfCareTesting #Biosensors #Type1Diabetes #KidneyDisease #LancasterUniversity #ResearchImpact
You can access the Briefing here:
