Question to the Department of Health and Social Care:

To ask Her Majesty's Government why the definition of a health institution as defined in the Guidance on the regulation of In Vitro Diagnostic medical devices in Great Britain, published in January, differs from that in the MHRA guidance on the health institution exemption (HIE) – IVDR and MDR (Northern Ireland), published on 1 January.

The Northern Ireland Protocol has resulted in the European Union Medical Device Regulation (MDR) (2017/745) and the EU In Vitro Diagnostic Regulation (IVDR) (2017/746) taking direct effect in Northern Ireland on 26 May 2020 and 26 May 2022 respectively. In its guidance on the application of EU MDR and EU IVDR in Northern Ireland, the Medicines and Healthcare products Regulatory Agency (MHRA) has included the definition of a ‘health institution’ as determined by the EU.

The UK Medical Devices Regulations 2002 (as amended) does not define ‘health institution’. As a result, the MHRA has provided its own interpretation, which was set out in MHRA guidance on in vitro diagnostic medical devices when it was first published in August 2013. The MHRA continues to rely on this interpretation of the definition for Great Britain and this has not been altered in subsequent updates. However, this issue will be considered during the review of medical devices regulation taking place later this year.