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What is a Medical Device?
A medical device is an instrument, apparatus, appliance, software (including AI), or other article intended for human use that performs a medical purpose, such as diagnosing, monitoring, or treating a medical condition. Medical devices can range from simple items like thermometers to complex devices like pacemakers.
Purpose
Medical devices are used for a variety of purposes, including:
- Diagnosis: Identifying a medical condition.
- Monitoring: Tracking a condition or treatment.
- Treatment: Addressing a medical condition or injury.
- Alleviation: Reducing the symptoms or severity of a condition.
Examples
Medical devices include:
- Simple devices: Tongue depressors, medical thermometers, gloves, and bedpans.
- Complex devices: Pacemakers, hip prostheses, and deep brain stimulation systems.
- In vitro diagnostic devices: Reagents, test kits, and blood glucose meters.
- Imaging devices: Ultrasound machines, CT scanners.
- Software: Computer-aided diagnostics.
- AI: AI algorithms that can analyse X-ray images.
Are you planning on conducting an externally sponsored medical device study (hosted study) at UCLH or its partner hospitals?
- For commercial medical device studies information is available on our Commercial Research webpage.
- For non-commercial medical device studies information is available on our Assess, Arrange and Confirm webpage.
Are you planning on conducting a UCLH or UCL sponsored medical device study?
You will require funding, sponsorship via the JRO, REC approval and possibly MHRA approval depending on the device and study.
If you are working with a UCL CTU, they will inform us of your study as per our processes. If you are working with an external CTU or CRO, please email ctimps@ucl.ac.uk to discuss sponsorship and how the JRO can support your study.
First Step - Confirm the regulatory status of the device and approvals requires
Regulatory Status of Device | Will data from study be used for commercialisation? | Approvals Required |
|---|---|---|
| non-UKCA/CE marked device | Yes | REC and MHRA |
| No | REC (regulatory pathway will be confirmed by JRO) | |
| UKCA/CE marked device that has been modified | Yes | REC and MHRA |
| No | REC (regulatory pathway will be confirmed by JRO) | |
| UKCA/CE marked device that is being used outside its intended purpose | Yes | REC and MHRA |
| No | REC (regulatory pathway will be confirmed by JRO) | |
| UKCA/CE-marked medical device used in accordance with the conditions of the UKCA/CE-marking | Yes | REC and MHRA |
| No | REC (regulatory pathway will be confirmed by JRO) |
Second Step - Determine type of study
Type of Medical Device Study | Definition | JRO Contact |
|---|---|---|
Proof of Concept / Pilot Study | Involves small samples of patients/volunteers to confirm that a device works, or to demonstrate the concept or principal of action. | For studies covered by healthcare exemption*
For studies not covered by healthcare exemption* *Healthcare exemption is where the device is manufactured by UCL/UCLH and not intended for commercialisation and only to be used at UCLH. |
Clinical Investigation for UKCA/CE marking purposes | A study to provide clinical data to support UKCA/CE marking of a general medical or an active implantable medical device. | |
Combined trial of an investigational medicinal product and an investigational medical device | A trial that involves the use of both an investigational medicinal product and an investigational medical device | |
Performance Evaluation for UKCA/CE marking | An investigation of an in-vitro diagnostic medical device, intended to validate the performance claims under the anticipated conditions of use. | |
Post-market study | Study involves a UKCA/CE-marked medical device used in accordance with the conditions of the marking. |
For all medical device studies, we recommend that you have an initial discussion with the JRO medical device regulatory experts, to discuss your proposed study, its regulatory pathway and approvals required. Please email ctimps@ucl.ac.uk.
