Question to the Department of Health and Social Care:

To ask Her Majesty's Government what estimate they have made of the number of users of Second Sight Medical Products in the UK have been affected by the company's collapse; what assessment they have made of the risk of other such medical device companies collapsing; and what steps they are taking to protect the consumers of such medical devices.

No estimate has been made. The Medicines and Healthcare products Regulatory Agency (MHRA) has not received any reports to indicate that Second Sight have withdrawn or failed to provide product support to existing patients. Additionally, NHS England does not routinely commission products supplied by Second Sight.

No assessment of the risk of medical device companies collapsing had been made. While there is an obligation on manufacturers to confirm the safety and performance of the devices throughout their lifetime, if a company is sold, the liability for these post-market requirements is usually a matter for the contract between parties. The MHRA is considering how post-market obligations on manufacturers can be strengthened in the forthcoming amendments to the Medical Devices Regulations 2002.

When contracting for the supply of medical devices, due diligence is undertaken on the financial standing of a supplier by procurement teams to gain assurance of the supplier’s ability to maintain supply in line with contractual and regulatory obligations. Patients remain in the care of prescribing clinicians who will make decisions on treatment and care in the event that supply of a product or service is disrupted. The Department monitors supply threats through engagement with suppliers and trade associations and uses intelligence to identify potential disruptions.