Devices are used in research to either support a study or in device-centred studies.
Supporting a study
In these cases, CE-marked medical equipment is used as intended by the manufacturer as part of the routine standard of care or above that standard of care.
- Evaluation of CE-marked equipment, used as intended by the manufacturer to gather more data on the device’s performance and effectiveness;
- MHRA clinical investigations for commercialisation purposes – for such studies, you will need to obtain a “Letter of No Objection” from the MHRA; and
- Pre-CE marking or for proof of concept (POC) studies to assess feasibility or intent. In these studies, there is no commercialisation intent, hence no MHRA involvement.
Barts Health is obliged to ensure safety in the use of devices in research. Clinical Physics, therefore, performs local safety assessments of the use of CE-marked and non-CE marked devices in research.
Depending on the study type and device use, Clinical Physics provides the following services:
- Advice on the procurement of CE-marked equipment for research studies
- Acceptance of loaned/purchased CE-marked equipment used for research which includes:
- Visual checks & electrical safety testing of research equipment
- Function testing (depending on capacity and capability)
- Registration on the equipment database
- Checking appropriate indemnity cover is in place for equipment provided on a loan or transfer basis (doesn’t apply to trust-owned/purchased equipment)
- User training checks
- Maintenance (dependent on capacity and capability)
- Performing risk assessments of experimental non-CE marked devices (depending on capacity and capability)
- Advice on storage & disposal
All Clinical Physics activities are currently performed at the study set-up stage, except for maintenance. The activities performed depend on the study type.
Researchers and investigators are responsible for requesting Clinical Physics approval before using any devices(s) for research activities (with a medical/clinical intent). Please see the Guide to information and documentation required by Clinical Physics [PDF 734KB] for what to send.
Researchers should send all research queries to firstname.lastname@example.org. Clinical Physics will respond to requests within 14-days with the outcome of the assessment or a request for further information.
Please note: a fee is applied to all device studies requiring Clinical Physics support – see Clinical Physics' research device assessment costs [PDF 1,545KB] for further details.