Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, how many UK Conformity Assessed certificates have been issued for (a) invitro diagnostic and (b) other medical devices since the introduction of those certificates.

Since January 2021 designated UK Approved Bodies have been able to issue UK Conformity Assessed certificates for medical devices and in vitro diagnostics (IVDs) that require certification by a conformity assessment body prior to the device being placed on the Great Britain market. Low risk medical devices and IVDs do not require Approved Body certification. Approved Bodies issue certificates attesting that the manufacturers Quality Management System complies with regulatory requirements as well as issuing certificates that confirm the devices themselves comply with the requirements. Certificates issued by an Approved Body generally cover more than one device, so the number of certificates does not equate to the number of devices that have been certified. The following table shows the number of certificates issued from January 2021 to 13 April 2023, the most current data set.