Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether his Department has had discussions with medical device manufacturers on the system for receiving UK-based Notified Body CE marking for the EU after the UK leaves the EU; and if he will make a statement.

The United Kingdom and its Notified Bodies have been integral to ensuring a safe and harmonised regulatory environment within the European Union.

On 19 March 2018 my Rt. hon. Friend the Secretary of State for Exiting the European Union, David Davis confirmed that the UK and EU have agreed a fixed implementation period of 21 months, lasting until December 2020. During this time, access to each other’s markets will continue on current terms, providing certainty for businesses and citizens across the EU and UK and time to prepare for the future.

The Prime Minister’s Mansion House speech of 2 March 2018 set out what we are aiming for. This included the ambition to agree a comprehensive system of mutual recognition for the trade of goods between the EU and UK – including medical devices. If agreed, this approach would ensure that, as now, products only need to undergo one series of approvals, in one country, to show that they meet the required regulatory standards - including UK based Notified Bodies being able to carry out assessments on behalf of the EU.

The outcome is dependent on negotiations, but both parties have a shared aim to protect the health of patients across Europe; and to ensure the safe and timely access to medical devices, even if our precise relationship will - by necessity - change.

The Government is examining all areas of the UK economy after the UK’s withdrawal from the EU, and seeking input from a wide range of stakeholders – including medical device manufacturers. We have had regular meetings with medical device stakeholders to understand their views on regulatory requirements after the UK leaves the EU, and will continue to do so.