Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps his Department is taking to ensure that regulatory frameworks at (a) Manchester Royal Eye Hospital and (b) other hospitals do not inhibit patients in obtaining (i) prosthetic eyes and (ii) novelty prosthetics through the National Artificial Eye Service.

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for the development and implementation of regulations for medical devices placed on the United Kingdom’s market, irrespective of the specific hospital in which they are used. All devices, including prosthetic eyes, must meet the relevant requirements of the UK Medical Devices Regulations 2002 (MDR 2002).

The MHRA is developing a future regulatory framework for medical devices that will ensure patients have access to the safe and effective medical devices they need, including prosthetic eyes and other custom-made devices. The first step is the introduction of new Post-Market Surveillance regulations, which came into force in June, putting in place strengthened legal requirements for how manufacturers monitor and report on their devices once they are being used in the real world. We intend to follow this with updates to the MDR 2002, which will enter into force next year, bringing further risk-proportionate improvements to ensure device traceability and patient safety. This will include additional measures that must be taken before a product can be placed on the market, including enhanced requirements for custom-made devices. To support patient access to medical technologies, the MHRA recently consulted on proposals to introduce an international reliance scheme to enable swifter market access for certain devices that have already been approved in a comparable regulator country. The agency will publish a response to that consultation in due course.