To ask the Secretary of State for Health and Social Care, what discussions his Department has had with relevant stakeholders moving medical devices from Great Britain to Northern Ireland on providing clear guidelines to assist compliance with the EU Medical Devices Regulation.
20 May 2021
The Government is committed to helping ensure there is no disruption to the supply of medical devices into Northern Ireland. The Department of Health and Social Care, the Medicines and Healthcare products Regulatory Agency (MHRA) and the Department of Health in Northern Ireland have been working closely with industry to support them in their preparations to comply with the European Union Medical Device Regulation (MDR), which will come into effect in Northern Ireland from 26 May this year.
The Government is not seeking any mitigations from the European Commission regarding the MDR. Following feedback from industry stakeholders and in recognition that guidance from the EU is pending, on 5 March 2021 the MHRA published guidance on importation requirements to assist with compliance in moving medical devices from Great Britain to Northern Ireland. On 10 May 2021, the MHRA wrote to industry to provide further support and clarification on the implementation of the MDR in Northern Ireland.