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:
- MHRA approval is required (UK MDR 2002 or EU MDR Article 62)
- An opinion from a Research Ethics Committee (REC) must be obtained
- If research is conducted in the NHS (England or Wales), HRA/HCRW approval is also mandatory, combining governance review with the ethical opinion.
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.