MHRA Disapplies Requirement for Clinical Trial Sponsors to be Established in EU or Northern Ireland
The MHRA has updated its guidance to disapply the requirement for sponsors of clinical investigations in Northern Ireland to be established in the EU or Northern Ireland. This change will make it easier for sponsors to conduct clinical trials in Northern Ireland and support the development of new medical devices and diagnostics.
🔗 Original Document: https://www.gov.uk/guidance/medical-devices-eu-regulations-for-mdr-and-ivdr