Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment he has made of the capacity of (a) UK Conformity Assessment Bodies and (b) EU Notified Bodies to conduct timely accreditation and certification of medical devices.

The Medicines and Healthcare products Regulatory Agency (MHRA) is supporting an increase in approved body capacity to ensure the United Kingdom can transition all medical devices to the UK Conformity Assessed (UKCA) marking system. The MHRA also works with international regulators and organisations to enhance the reputation of the UKCA mark and prevent disruption to the UK’s supply of medical device products. The MHRA is working with the already designated approved bodies, those organisations applying for this status and industry to assess whether this will deliver the required capacity.

We are engaging with industry partners to understand capacity issues within the European Union notified body system, which may impact the supply of devices to the UK market and assess what further action may be required to maintain supply of medical devices.