MHRA advises quarantine of medical devices supplied without appropriate conformity markings

The Medicines and Healthcare products Regulatory Agency (MHRA) has identified medical devices supplied in the UK without the mandatory conformity markings required under UK and EU regulations. Affected products include those used in clinical procedures such as blood collection, infusion, surgery, and wound management. The MHRA has not reported any defects or safety issues but notes the lack of conformity assessments raises concerns about compliance with UK regulatory standards. Healthcare professionals and organisations are advised to stop using and supplying these devices immediately.

The MHRA has published guidance and images of the affected devices, including a Bone Marrow Biopsy Needle from Meditech Devices Pvt. Ltd., in its Device Safety Information (DSI). Organisations are instructed to quarantine any remaining stock and use compliant alternatives. The MHRA has requested that organisations notify it immediately if they have received, supplied, or distributed affected devices, providing details of onward distribution where known.

Distributors have been directed to cease further supply of the non-compliant devices and assist with traceability efforts upon request. Healthcare professionals are required to report any suspected or actual adverse incidents involving these devices through regional reporting systems. The MHRA has emphasised the importance of verifying device compliance to ensure adherence to UK safety regulations.

The MHRA is the UK’s regulator for medicines and medical devices, operating under the Department of Health and Social Care. It ensures products meet safety and efficacy standards through evidence-based assessments. Organisations in possession of affected devices must notify the MHRA via devices.compliance@mhra.gov.uk, quoting DSI reference DSI/2026/007.