MHRA Consultation on the future regulation of medical devices in the United Kingdom

The MHRA is now inviting members of the public to provide their views on possible changes to the regulatory framework for medical devices in the United Kingdom (UK). This consultation closes on 25th November 2021. Now is the time to have your say and influence the direction of travel.

The powers granted in the Medicines and Medical Devices Act (2021) allow the UK Medical Devices Regulations 2002 to be amended. New amendments are going to be made which will create the new regime for the future of medical device regulation in the UK. The amendments are scheduled to be in force at the beginning of July 2023 and this timing will align with the date from which CE marked medical devices will no longer be recognised in Great Britain and UKCA marking will be fully applicable.

The scope of this consultation has been informed by early engagement with a range of stakeholders and it sets a series of proposals which is intended to make the UK the most attractive place to research, develop, produce, and supply safe and innovative medical devices. Further, to meet the Government’s ambition to be at the forefront of medical device innovation and to boost patient safety and support the continued growth of the MedTech and diagnostics sector across the whole of the UK.

Exciting times ahead and it is most important that industry takes this opportunity to feed in.

Find the consultation questions here