Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether he is taking steps to help ensure that the Medicines and Healthcare products Regulatory Agency process for registering medical devices facilitates an adequate level of supply of safe medical devices.

The Medicines and Healthcare products Regulatory Agency (MHRA) intends to strengthen the regulation of medical devices as set out in the Government’s response to the consultation on the future regulation of medical devices in the United Kingdom. Availability of medical devices remains a key consideration as we develop this future regime, including aspects on medical devices registration.

The MHRA continues to recognise the importance of availability of medical devices in the UK, and is taking a variety of steps to help ensure continuity in supply of medical devices. Firstly, the MHRA will consider applications for an exceptional use authorisation where there is a clear clinical need for a device, that does not otherwise have a valid Conformité Européene (CE) or UK Conformity Assessed (UKCA) mark, to remain on the market. We assess applications for European Union Allowance based on the needs of patients. The MHRA is also working to expand Approved Body capacity to enable more manufacturers to obtain UKCA marking. Four bodies have already been designated and a further six are progressing through the designation process, with more in the pipeline.

In addition to this, the MHRA is working to ensure adequate transitional arrangements for its future regime for medical devices, including continued acceptance of CE marked medical devices taking into account the revised transitional arrangements for European Union (EU) medical devices regulations being progressed in the EU, which will apply in Northern Ireland. Finally, MHRA is working to ensure industry have clear guidance on registration requirements as the above progress and recently published an update on EU timeline revisions to support this.