Medical Equipment: Certification Quality Marks

(asked on 8th May 2018) - View Source

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether it is his policy that the British Standards Institute should be able to continue to CE Mark medical devices after the UK has left the EU.


Answered by
Jackie Doyle-Price Portrait
Jackie Doyle-Price
This question was answered on 11th May 2018

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 undertaking a wide range of analysis looking at the implications of UK withdrawal from the EU. Our programme of analysis is constantly developing and evolving, and includes sectoral analysis. The Government is examining all areas of the UK economy and seeking input from a wide range of stakeholders.

Reticulating Splines