Clinical investigations in Northern Ireland

AI Summary

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance for manufacturers conducting medical device clinical investigations in Northern Ireland. Under the Northern Ireland Protocol, these investigations must align with the EU Medical Device Regulation (EU MDR) and the In Vitro Diagnostic Medical Device Regulation (EU IVDR). While the guidance references the May 26, 2021 transition for legacy devices, it primarily focuses on the ongoing requirement for authorization before studies begin. Main violations or grounds for refusal include submitting incomplete applications, failing to provide sufficient evidence of device safety and clinical benefit, or submitting protocols that do not reflect current scientific knowledge. Failure to adhere to these regulations is a criminal offense and can lead to the revocation of study authorization or the termination of the investigation. Required actions for manufacturers include: - Submitting notifications via the Integrated Research Application System (IRAS) at least 65 days before the investigation starts. - Appointing a legal representative within Northern Ireland or the EU if the sponsor is not established there. - Ensuring all devices are labeled 'exclusively for clinical investigation.' - Reporting serious adverse events (SAEs) and providing quarterly safety updates through the MORE portal. - Obtaining approval from a UK Research Ethics Committee (REC). - Submitting a final clinical investigation report within one year of study completion. By meeting EU MDR standards, a single application to the MHRA can cover clinical sites across both Northern Ireland and Great Britain.