It is important to note that the rules for notifying the MHRA of a clinical investigation in
Great Britain (England, Wales and Scotland) differ from those applicable to Northern
Ireland.
The Northern Ireland Protocol requires Northern Ireland to continue to align with EU rules
for devices after 1 January 2021. Therefore, the Medical Device Regulation (EU) 2017/745
(MDR) and the In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR) will apply in Northern Ireland from 26 May 2021, and 26 May 2022 respectively, in line with the EU’s implementation timeline.
This means that clinical investigations being conducted in Northern Ireland must meet the
requirements of the EU MDR and be submitted to MHRA in accordance with these
regulations. Clinical investigations being conducted in Great Britain need to meet the requirements of the UK MDR 2002…
