Guidance

MHRA guidance on the health institution exemption (HIE) – IVDR and MDR (Northern Ireland)

The Regulations for in vitro diagnostic medical devices (IVDs) and medical devices (MDs) will keep the exemption for manufacturing or modifying and using IVDs or MDs within the same health institution.

Documents

MHRA guidance on the health institution exemption (HIE) – IVDR and MDR (Northern Ireland)

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Details

This guidance is only relevant for healthcare institutions in Northern Ireland. For information on the regulation of medical devices on the Great Britain market (England, Wales and Scotland), please see our published guidance.

Published 1 January 2021