Health institutions to have say in MHRA’s reforms for in-house manufactured medtech

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has released a survey to gauge health institutions’ views on the in-house manufacturing exemption for medical devices.

The request comes as the MHRA looks to refine the health institution exemption policy within the medical devices regulatory framework that functions as a guide towards UK health institutions’ delivery of “safe, effective, and innovative” devices to patients. The policy, signed into effect in 2021, exempts medical devices made and used by health institutions from certain requirements.

Building on the government’s response to the 2021 consultation on the future regulation of medical devices in the UK, the latest consultation will support the execution of the Medical Devices Regulatory Reform (MDRR) roadmap. The MHRA said the latest consultation was a chance to consider the “promising opportunities” that further evolution of the MDRR could hold.

According to the MHRA, policy areas that could be ideated on include extending access to enable exempted devices to be used beyond health institutions and further post-market surveillance (PMS) dictates to improve the visibility of exempted devices.

The first part of the policy’s reformation plans was introduced in the form of amendments to the PMS requirements for medical devices in June. Under the new terms, medical device manufacturers with products with a UKCA or CE mark placed on the UK market after 16 June 2025 are now required to ‘proactively track’ their safety and performance.

The MHRA also foresees refinement to the MDRR as protecting policy around reform shifts. Referencing potential shifts in the future from hospital to community care, analogue to digital, and sickness to prevention, the agency is likely referring to the UK Government’s 10-year plan for the UK National Health Service (NHS).

Speaking at a community health centre in London in July, Health Secretary Wes Streeting outlined the plan’s inclusion of a shift from the NHS being a “sick service” to one that is preventative. UK Prime Minister Sir Keir Starmer, who also appeared at the event, said the aims would be achieved with a stronger focus on early diagnosis and screening with the use of technology such as AI.

An MHRA spokesperson said: “We recognise the need for clear confines on when the exemption can be applied.

“To shape the policy further, we will continue to gather insights from health institutions across Great Britain. Your inputs will inform our understanding of current practice, and better shape subsequent consultations, guidance, or regulatory updates we plan in the coming year.”