Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what (a) risk assessment has been carried out on and (b) regulations govern the use of mesh as a treatment for hernias; and what progress has been made on establishing the UK-wide Medical Device Information System.

The benefits and risks of using mesh for hernia repair have been considered in detail by clinicians and the professional bodies who represent them and there remains a clinical need for these devices.

The requirements of the medical device regulations are such that the manufacturer of the medical device must hold all relevant scientific and clinical evidence to demonstrate the safety and performance of their device before they can place the product on the market. For these types of devices, they must then obtain certification from an independent third-party conformity assessment body who will undertake a full review of all the manufacturers data and how it supports the claims being made. Once they are satisfied that the device is safe and performs as expected they will issue a certificate to the manufacturer confirming that they device complies with the regulations.

A UK-wide Medical Device Information System (MDIS) is being developed. We intend to begin a formal public consultation on the MDIS regulations later this year with the aim of laying the regulations in due course, subject to parliamentary time.