The NHS England Outcomes Registries Programme (ORP) was established in 2022 to develop a single, unified registry solution. This consolidates existing implantable device-level registries and implements new (non-device related) clinical outcome registry data collections to address data and vigilance gaps, enabling the prevention of patient safety issues and adverse outcomes.

Over 2 million patients a year undergo a procedure that includes a high-risk medical device. The programme addresses the need for a more consistent approach to assure safety, enable good outcomes, and fulfils the recommendations of the Independent Medicine and Medical Device Safety Review (IMMDS) (2020) and the Paterson Inquiry (2020).

NHS England has a priority list of new registries to be developed as well as providing a secure stable location for existing at-risk registries that cover a variety of specialisms. Subsequent registry datasets will be linked to or integrated within the solution and have been developed alongside patient reported outcome measures (PROMS) and patient reported experience measures (PREMs).

Currently the National Major Trauma Registry and Breast and Cosmetic Implant Registry are linked into the programme to provide data. The National Registry of Hearing Implants has now also gone live, with ongoing work to establish the Pelvic Organ Prolapse and Stress Urinary Incontinence Registry and The Orthopaedic Trauma Registry as well as working alongside registries like the National Joint Registry and National Vascular Registry who undertake their own research and assessment.

In collaboration with the devolved administrations, the programme is also developing an approach to enable secure data sharing, system interoperability and UK-wide coverage, where it is appropriate to do so. 

The Medical Devices Outcome Registry

The Medical Devices Outcome Registry (MDOR) was established as the data collection for implantable device data. MDOR takes data from different collections to create a single unified view of implantable devices and associated outcomes.

Where no current registry exists, data can also be submitted to MDOR directly. Work is ongoing with trusts to establish these direct submissions, with the aim of engaging with all healthcare providers, systems and major independent sector healthcare providers, with at least 90% of NHS providers submitting by 30 April 2026.

What is an outcome registry?

Outcome registries are organised systems that use observational methods to collect routine, uniform data on specified outcomes in a population defined by a particular disease, condition, or exposure. Important features of registries include:

• collection of high-quality, high-volume patient, practice and population-level data
• development input and expertise from clinical leadership
• availability of enriched, comparative data for multiple upstream patient safety and quality improvement purposes
• timely feedback of data to inform clinical decision-making

Outcome registries can often be confused with clinical audits that measure care against explicit audit criteria as part of a quality improvement cycle. Data is collected less frequently in audits and often with lower levels of data granularity than in routine registry data collections.

What will the benefit be to patients?

The fundamental purpose of the ORP is to capture data from NHS and private healthcare providers to detect and predict issues relating to patient safety and outcomes and prevent harm to future patients. The registry will also:

• maximise data for surveillance, benchmarking and recall activities
• increase transparency and accountability
• enhance research and development
• reduce costs of participation

Accurate data that is routinely collected at the point of care and linked to patient outcomes will allow stakeholders to turn intelligence into actionable improvements. The data will enable organisations to:

• help identify patients who have received specific implants that are subsequently performing poorly
• determine how long different types of implants last
• empower patients by helping them find out more about the devices available to them
• help surgeons choose the best devices for their patients
• improve patient safety by monitoring how well implants, surgeons and hospitals perform and take action where necessary
• give hospitals, surgeons and implant manufacturers feedback about their performance to help them improve patient care
• invite patients to take part in feedback activities about their surgery, so that patient outcomes, experience and satisfaction can be assessed and monitored

If you have any questions, please email england.support.outcomeregistries@nhs.net

If you are a provider who has not yet engaged with the programme but would like to work towards submitting data, please email england.mdor.outcomesandregistries@nhs.net