From proof-of-concept to clinical investigation: Understanding the transition in MedTech development

by Jazmin McCalla-Bedward | 13 May 2025

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In medical device innovation, the line between academic research and regulated clinical investigation can be finer than it seems -especially under the EU MDR and UK MDR 2002.

At the proof-of-concept stage, research may involve testing a device or subsystem (like an algorithm or sensor) without a specific medical purpose, for example validating the detection of breathing rate in healthy volunteers. In such cases, university ethics approval may be sufficient.

However, once a study aims to gather data for a medical purpose, for example, using that breathing-rate sensor to support the diagnosis of respiratory disease, this investigation typically qualifies as a clinical investigation.

If you need to perform a clinical investigation for that device, it means that:

These steps are not just regulatory obligations - they are critical safeguards to ensure the safety, rights, and well-being of participants while building a strong foundation for eventual market approval.

As academia and industry increasingly collaborate to bring MedTech to life, understanding these early-stage regulatory boundaries is key to accelerating innovation responsibly.

MHRA Clinical Investigation Guidance Document

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