Operation of the health institution exemption (HIE) – IVDR and MDR (Northern Ireland)
The EU has published guidance on exemptions for medical devices manufactured and used within EU health institutions, which applies to Northern Ireland-based health institutions, replacing interim guidance from the MHRA.
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Article 5(5) of the EU Medical Devices Regulation (2017/745) (MDR) and in vitro Diagnostic Medical Devices Regulation (2017/746) (IVDR) exempts medical devices that are manufactured and used within EU heath institutions from meeting certain regulatory requirements, including CE marking requirements and the need for third-party conformity assessment by a Notified Body, provided that conditions set out in the Article are met. Under the terms of the Windsor Framework, this provision also applies to Northern Ireland-based health institutions.
The EU Medical Devices Coordination Group (MDCG) has published guidance on the health institution exemption under Article 5(5) of the MDR and IVDR.
This MDCG guidance is relevant for healthcare institutions in the EU and Northern Ireland.
The former MHRA guidance on the health institution exemption has been withdrawn. Northern Ireland-based health institutions wishing to manufacture and use medical devices and IVDs under the exemption should refer to the above MDCG guidance. See Operation of the health institution exemption for EU IVDR and MDR.
For information on the regulation of medical devices on the Great Britain market (England, Wales and Scotland), please see our guidance Regulating medical devices in the UK.