For HealthTech guidance that started development between the 14 July 2025 and the 22 October 2025, the previous version of the HealthTech Manual applies.
- Status:
- In progress
- Technology type:
- Device
- Decision:
- Selected
- Reason for decision:
- Anticipate the topic will be of importance to patients, carers, professionals, commissioners and the health of the public to ensure clinical benefit is realised, inequalities in use addressed, and help them make the best use of NHS resources
- Description:
- In the UK, more than 11,000 people die due to liver disease each year, and numbers are rising (British Liver Trust 2023). Liver transplantation is an effective treatment option for people with end-stage liver disease and some types of liver cancer. A liver transplant is surgery to remove a diseased liver and replace it with a healthy one from another person (donor). People identified as needing a liver transplant are placed on a waiting-list for a donor liver. Demand for liver transplants is high and some people die on the waiting-list or are removed due to ill health before receiving a donor liver (NHS Blood and transplant 2023). Livers are usually stored in ice between removal from a donor and transplant, to minimise damage. In the UK, many donor livers are discarded because clinicians are concerned about giving potentially lower quality livers to people. These decisions are based on the characteristics of the donor and the appearance of the liver because it is not possible to assess how well the liver is functioning during cold storage. Ex-situ machine perfusion devices preserve the donor liver outside the body. The aims of these devices include increasing the number of livers suitable for transplant, extending how long the liver can be stored for to enable more flexibility in the timing of transplant operations and improving the outcomes of transplant recipients. Perfusion machines vary in many ways including the temperature at which they keep the donor liver. Some also allow assessment of liver function during preservation to help the surgeon decide if the liver is appropriate to transplant.
Provisional Schedule
- Committee meeting: 1:
- 23 April 2026
- Draft guidance:
- 20 May 2026 - 11 June 2026
- Committee meeting: 2:
- 25 June 2026
- Resolution:
- 23 July 2026
- Expected publication:
- 20 August 2026
Project Team
- Project lead
- Toni Gasse
Email enquiries
If you have any queries please email MedTech@nice.org.uk
- External Assessment Group:
- Centre for Reviews and Dissemination and Centre for Health Economics, University of York
Timeline
Key events during the development of the guidance:
| Date | Update |
|---|---|
| 04 November 2025 | The scope has been updated to remove OCS Liver from the assessment, following correspondence from TransMedics advising that they will not be making OCS Liver available to the NHS for the use case specified in the scope. |
| 11 September 2025 | Final scope |
| 04 September 2025 | Following the scope consultation the webpage has been updated with the anticipated schedule for the Routine Use Assessment in accordance with the NICE HealthTech Programme manual (PMG48). |
| 14 August 2025 - 29 August 2025 | Draft scope consultation |
| 18 July 2025 | Following the scoping workshop held on Thursday 10th July 2025 it was identified that ex-situ machine perfusion devices for liver transplantation are currently in use across all transplant centres in the UK. Stakeholders also highlighted a substantial body of evidence that they believe is relevant to this assessment. Additionally, it was noted that guidance outlining recommended use of these devices in routine care would be valuable to the healthcare system. Following internal discussions, the decision has been made to proceed as a routine use assessment. Information on the new HealthTech programme manual is available on the NICE website. |
| 10 July 2025 | Scoping workshop |
| 13 May 2025 - 11 June 2025 | Specialist committee member recruitment |
| 13 May 2025 | Launch |
| 13 May 2025 | In progress. Topic launch |
| 04 March 2025 | Awaiting development. Status change linked to Topic Selection Decision being set to Selected |
For further information on our processes and methods, please see our HealthTech programme manual.