Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, if he will take steps to help ensure that NuMed Healthcare will not cease to import equipment made for the treatment of children with heart disease from the US after January 2023.

NHS Supply Chain has not received communication from NuMed Inc Products’ United Kingdom distributor on potential disruptions to the supply of paediatric cardiology devices, once new regulatory requirements come into effect on 1 July 2023. Due to the large volume of suppliers and the array of specialised products available under NHS Supply Chain’s framework, the incoming regulation changes are not expected to cause supply or resilience issues within the National Health Service as there are suitable alternatives available.

The Medicines and Healthcare products Regulatory Agency is currently finalising the response to the public consultation on future medical device regulation, which will outline the new regulatory requirements from 1 July 2023 and appropriate transitional arrangements. The consultation considered routes to market for medical devices once regulatory changes take place and any proposals will be outlined in the response. Officials are engaging with industry stakeholders on the future approach to regulating medical devices.