To ask the Chancellor of the Duchy of Lancaster and Minister for the Cabinet Office, whether the Draft unilateral declarations by the European Union and the United Kingdom of Great Britain and Northern Ireland in the Withdrawal Agreement Joint Committee on human and veterinary medicines cover medical devices.
24 December 2020
The Unilateral Declaration on Medicines (available on gov.uk) allows for the phased implementation in Northern Ireland of relevant medicines regulation, and in particular the Falsified Medicines Directive. Medical devices are not subject to the Falsified Medicines Directive and are not in scope of the declaration. Businesses and authorities moving medical devices can make use of the Trade Support Service and the UK Trader Scheme. Full guidance on the regulatory requirements for medical devices are set out on gov.uk. Medical devices will be able to be moved smoothly between Great Britain and Northern Ireland from 1 January 2021.