Question to the Department of Health and Social Care:

To ask His Majesty's Government what assessment they have made of the impact of proposals to indefinitely recognise CE-marked medical devices on the availability of medical technologies in the UK.

Approximately 90% of medical devices currently on the British market are CE marked and their continued supply to the National Health Service and wider health system is vital for patient access to essential products. The Medicines and Healthcare products Regulatory Agency recognises CE marked products until 2028 or 2030, depending on risk classification and the European Union legislation they comply with. The proposals are intended to allow continued access to medical devices that have been assessed as safe and effective in the EU while aligning with international best practice. As Northern Ireland follows EU medical devices regulations, continued recognition of CE marked medical devices in Great Britain would further support the functioning of the UK Internal Market, as manufacturers could continue to place the same product on the entire United Kingdom market.

The proposals are anticipated to drive growth in the medical technology sector by reducing administrative costs and safeguarding the continued supply of medical technologies. The purpose of the proposed policy is to enable indefinite market access for CE marked medical devices on the British market. The impact on safety, availability, and favourability may vary depending on whether all devices are recognised, or just devices that are the same risk class in Great Britain, or lower. An assessment of each proposal against the availability of medical devices can be found in Annex C of the published consultation document, which is available on the GOV.UK website.