Thu Sep 19 09:01:30 UTC 2024: ## Northern Ireland Approves First In Vitro Diagnostic Device Application Under EU IVDR
**Belfast, Northern Ireland** – The Medicines and Healthcare products Regulatory Agency (MHRA) has announced the approval of the first application for In Vitro Diagnostic (IVD) devices under the EU In Vitro Diagnostic Medical Device Regulation (IVDR) in Northern Ireland. This milestone follows the recent implementation of a new submission route for manufacturers to conduct performance studies.
The new process, developed over the past 18 months in collaboration with the Health and Social Care Northern Ireland (HSCNI) and the Health Research Authority (HRA), marks a significant step forward in the regulatory management of IVDs within Northern Ireland. It ensures a robust and efficient process for handling future applications.
“This is a key achievement in our work to improve public and NHS access to safe and effective medical technologies,” stated a spokesperson for the MHRA. “We look forward to further developments as we continue to support the implementation of this initiative.”
The approval comes under the terms of the Windsor Framework, which outlines different regulations for placing medical devices on the Northern Ireland market compared to Great Britain. The EU MDR and IVDR have been in effect in EU Member States and Northern Ireland since May 2021 and 2022, respectively.
The MHRA welcomes inquiries regarding the application process and future submissions. Guidance on submitting an application under the EU IVDR can be found on the MHRA website.
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