The Medicines and Healthcare products Regulatory Agency (MHRA) is the regulator of medicines, medical devices and blood components for transfusion in the UK. The MHRA is responsible for ensuring that medical devices are safe and perform as intended for patients.
Medical devices are products used for medical purposes, such as diagnosis, prevention, monitoring or treatment of diseases or injuries. They include a wide range of products, such as pacemakers, artificial hips, blood glucose meters, pregnancy tests, medical decision support software, syringes, surgical instruments and wheelchairs.
At the MHRA, we put patients first in everything we do, right across the lifecycle of the products we regulate, and we ensure that medicines and healthcare products available in the UK are safe and effective. We want to develop a future regime for medical devices that enables:
- improved patient safety
- innovation;
- close alignment with international best practice; and
- risk proportionate regulation of medical devices.
Medical devices and in vitro diagnostic (IVD) devices in Great Britain (England, Wales, and Scotland) are regulated under The Medical Devices Regulations 2002.
We are seeking views on the following proposals:
- Extending the current transitional arrangements for devices that comply with the Medical Device Directive (MDD) to align with the EU timelines for devices to transition from MDD to EU Medical Device Regulation (EU MDR),
- Indefinitely recognising devices that comply with the EU MDR and EU In Vitro Diagnostic Medical Devices Regulation (EU IVDR),
- Introducing an international reliance route for devices that comply with the EU MDR and EU IVDR where the device classification is higher under the MDR 2002.
We welcome the views from anyone who will be impacted by the proposals, including medical device manufacturers and distributors, trade associations, regulatory experts, approved bodies, healthcare professionals including clinicians and those involved in procurement of medical devices, devolved administrations and patient representative organisations.
This consultation applies to medical devices in Great Britain. For guidance on the regulation of devices in Northern Ireland, see Regulation of devices in Northern Ireland.
Please read the consultation document prior to completing the consultation survey. You may benefit from having this available when answering the questions.
You do not need to complete the questions in one go, click the same link and you will be able to come back to it at another time to finish it off. Please note that only fully submitted responses will be analysed.
The deadline to complete this consultation is Friday 10 April 2026.
This consultation includes free text boxes. Please do not include any information in your answers that could identify you or a third party. If you require any further information about how the MHRA processes your data, please see the MHRA privacy notice.
If you have any questions please contact futuredevicesregulations@mhra.gov.uk.
