Rethinking MDOR: a clinical asset, not just a compliance exercise

As of April 2024, the Medical Devices Outcome Registry (MDOR) has been live to fulfil the recommendations of the Cumberlege Review and Paterson Inquiry. Many organisations are still working out what MDOR means in practice, and how best to approach it without adding pressure to already stretched clinical teams.

For those tasked with implementation, whether clinicians, data managers or other designated staff, MDOR presents not just a regulatory task as part of a national strategy for traceability and patient safety, but a chance to strengthen underlying systems, workflows, and quality of data.

As early adopters are well on their way in the process, including teams at North Tees and Hartlepool NHS Foundation Trust, there are suggestions of how to capture data effectively and extract wider value from MDOR, beyond necessary compliance.

From scanning to safety: elevating clinical assurance

MDOR mandates the traceability of high-risk medical devices through barcode scanning, but its implications go far deeper than box-ticking. When implemented effectively, scanning becomes a clinical safeguard, working to prevent wrong-site surgeries, expired product usage and laterality concerns.

Theatre teams empowered with a Point of Care (POC) system, fully integrated into their workflow, are demonstrating improved traceability and confidence in surgical safety. The opportunity lies in making scanning a primary element of the surgical process, not an afterthought.

Workforce- and workflow-first approach

The value of MDOR data starts with the people who capture it. In leading trusts, the key lesson is clear: technology needs to fit naturally into the way clinicians work—supporting them in real time, not slowing them down. When systems are built around the needs of staff, better data and better care follow.

This can be achieved by:

• Seamlessly integrating data capture into existing workflows, without disrupting theatre teams or adding pressure

• Providing flexible entry options, during surgery, immediately after, or by the end of the day, to suit different clinical environments

• Establishing a simple, sustainable way of working that teams can easily adopt, maintain, and champion

When these principles are prioritised, adoption and compliance occur naturally.

Turning submission into insight: data as a clinical asset

While national policy focuses on submitting MDOR data, the same information can serve useful, broader purposes internally, empowering clinical teams with actionable insights to support informed, data-driven decisions.

Key internal benefits include:

• Informed clinical decision-making: Enables clinicians to assess device performance in real-world use, improving patient care choices

• Quality improvement and patient safety: Identifies patterns in outcomes or complications, supporting early intervention and continuous improvement

• Evidence-based procurement: Supports selection of the safest, most effective devices by analysing actual performance and revision rates

• Operational efficiency: Helps reduce costs related to device failures, reoperations, and unwarranted variation in care

• Benchmarking and transparency: Allows comparison of device-related outcomes across sites, supporting consistency and accountability.

Theatres using platforms that provide structured, clinically meaningful data outputs, rather than raw reports, are better placed to drive continuous improvement.

Scaling effectively without administrative overload

Submitting data to MDOR doesn’t have to create additional burden for clinical teams. Trusts can start small, piloting data capture before gradually expanding. This phased approach reflects national guidance and builds on existing digital systems already in use.

By embedding data collection into familiar point-of-care workflows, such as using barcode scanning, trusts can minimise administrative effort. Framing MDOR as part of routine clinical practice, not just a compliance task, helps ensure it supports both staff and patient outcomes in a sustainable way.

MDOR may have begun as a national policy directive, but it’s also revealing gaps and strengths in how devices are recorded, tracked, and managed in real-world settings.

The organisations seeing the most benefit are those using the opportunity to modernise traceability, improve data flow, and build toward a more proactive model of surgical safety. Not every Trust is there yet, but as the landscape matures, those with scalable point-of-care systems already in place, accompanied by the right support, are likely to find themselves better positioned for what comes next.

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For those exploring how to address MDOR compliance, we'd be pleased to talk. Contact us, email: contact@carescan.com or call 01482 772536.

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