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26th May 2021
The guidance is being updated due to the EU Medical Device Regulation (MDR) coming into effect in Northern Ireland from 26 May. It provides technical details for clinical investigations in 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.
All clinical investigations involving a site in Northern Ireland must be submitted to the MHRA in line with the requirements of EU MDR 2017/745. This single application will also cover any sites proposed in Great Britain in addition to site(s) in Northern Ireland for the same clinical investigation.
The following sections provide guidance for these applications and the requirements for amendments and post market studies involving sites in Northern Ireland.