Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps he is taking to help ensure that UKMDR audit fees remain affordable for UK based businesses who source medical devices from overseas manufacturers.

In Great Britain, medical devices are regulated under the Medical Device Regulations 2002 (MDR 2002), which is available at the following link:

https://www.legislation.gov.uk/uksi/2002/618/contents/made

Manufacturers of the lowest risk medical devices can self-declare the conformity of their devices against these regulations, and manufacturers of medium and high-risk medical devices must seek third party conformity assessment from an approved body to obtain a UK Conformity Assessed (UKCA) marking.

Fees are set by the approved body themselves and vary depending on the specific service provided.

To protect supply, the government continues to accept CE-marked medical devices on the Great Britain market until 30 June 2028 or 2030, depending on the type of device and the legislation it complies with. If a device has a valid CE marking, the manufacturer is therefore not required to also obtain a UKCA marking. We will consult further on our long-term approach to the recognition of CE-marked medical devices later this year.

The Medicines and Healthcare products Regulatory Agency (MHRA) is currently developing a reformed regulatory framework for medical devices, designed to protect patient safety, while improving access to innovative medical devices. This will introduce an international reliance framework, allowing the MHRA to use the expertise and decision-making of other regulatory partners to introduce a new, streamlined, route to market for certain devices with prior approval from comparable regulatory countries (Australia, Canada and the US). This will reduce unwarranted regulatory burden on manufacturers of medical devices with overseas approval.