This requirement applies to the whole of the UK. Ethical approval for the purposes of the Medical Devices Regulations must be given by a Research Ethics Committee (REC) within the UK Health Departments’ Research Ethics Service (RES).

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In partnership with the Medicines and Healthcare products Regulatory Agency (MHRA), we can offer a new coordinated assessment for clinical investigations involving medical devices.

The MHRA and REC reviews are then done in parallel with our two organisations sharing information during the assessment process.

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Under the Medical Devices Regulations, ethical approval is required for a clinical investigation undertaken by, or with the support of, the manufacturer or another commercial company in order to demonstrate the safety and performance of a non-UKCA/CE UKNI/CE-marked medical device, or a UKCA/CE UKNI/CE-marked device that has been modified or is to be used for a new purpose.

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