The recent implementation of a submission route for manufacturers for performance studies has now enabled the submission and approval of the first application for In Vitro Diagnostic devices under the EU IVDR in Northern Ireland. This process was developed over the past eighteen months in collaboration with colleagues at HSCNI and HRA.
This marks a significant milestone in the regulatory management of in vitro diagnostics within Northern Ireland, demonstrating a robust and efficient process for handling future applications. We look forward to further developments as we continue to support the implementation of this initiative and our work to improve public and NHS access to safe and effective medical technologies.
The Medicines and Healthcare products Regulatory Agency (MHRA) is the Competent Authority for medical devices and In Vitro Diagnostic (IVD) devices in Northern Ireland. Under the terms of the Windsor Framework the rules for placing medical devices on the Northern Ireland market differ from those applicable to Great Britain (England, Wales and Scotland).
The EU Medical Device Regulation (2017/745) (MDR) and the In Vitro Diagnostic Medical Device Regulation (2017/746) (IVDR) have applied in EU Member States and in Northern Ireland since 26 May 2021 and 26 May 2022 respectively.
For any inquiries regarding the application process or future submissions, please contact us.
For guidance on submitting an application under EU IVDR see the link to guidance here