FOI release

ECT Devices - FOIA

Some or all of the information requested was not provided because we didn't hold it.

Case reference FOI2026/00098

Received 30 January 2026

Published 9 March 2026

Request

We are aware that Clinical Evaluation Requirements are needed so that ECT devices can achieve certification. To our understanding, these requirements are as follows: * Clinical evidence of effectiveness * Post-market surveillance plans * Adverse incident reporting systems (via MHRA) Based on the above, please provide the evidence that manufacturers are providing to the MHRA to demonstrate effectiveness for the purposes of satisfying Clinical Evaluation Requirements. Please provide this evidence for the MECTA ECT device and the Somatics ECT device, respectively.

Response

See attached

Documents

• FOI2026_00098 (redacted).pdf (660.3 KB)

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