Medical Equipment and Technology

(asked on 27th October 2022) - View Source

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether he has made an assessment of the effect of the EU Medical Devices Regulations assessment system on the availability medical device and health tech products in the UK; and what steps he is taking to provide patients in the UK with equal access to medical devices and health tech through the delivery of an effective UKCA marking system.


Answered by
Will Quince Portrait
Will Quince
This question was answered on 4th November 2022

The future medical devices regime is an overhaul of the current regulatory framework, aimed at improving safety and incorporating measures to encourage innovation and offer alternative routes to market. This includes domestic assurance, which will allow an abridged assessment with the appropriate scrutiny and United Kingdom approved bodies can reject applications under the domestic assurance route if the evidence provided is insufficiently robust. A number of countries will be considered for the domestic assurance route, including the United States of America.

The Medicines and Healthcare products Regulatory Agency (MHRA) is working to build closer partnerships with global regulators and has established full membership of the International Medical Device Regulations Forum (IMDRF) and is an official observer of the Medical Devices Single Audit Programme (MDSAP), of which the US Food and Drug Administration is a member. The MHRA is engaging with the FDA within international fora and on a bilateral basis.

The transitional arrangements for medical devices are intended to minimise the risks to access for patients in the UK and facilitate the transition between the current and new regulatory framework whilst supporting the ongoing safe supply of essential medical devices. CE marked devices under the new European Union regulations will continue to be placed onto the UK market when the new regime comes into force for up to a period of five years, with a view to review this provision at the end of the five-year period. It is not anticipated that an extension of this provision will be required, as the intervening period will be used to support an increase in approved body capacity to ensure the UK has sufficient capacity to transition all medical devices to the UKCA marking system. The MHRA will work with international regulators to place the UKCA marking for medical devices on a global standing.

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