MHRA Outlines Data Requirements to Support Regulatory Decision-Making
The Medicines and Healthcare products Regulatory Agency (MHRA) has published “MHRA data requirements to support regulatory decision making”, a research and analysis paper published on 2 July 2026.
The paper outlines the MHRA’s data needs and use cases, focusing on the limitations of the current UK health data landscape and how a future UK Health Data Research Service (HDRS) could help address existing gaps.
The MHRA states that, as the UK regulator for medicines, medical devices and blood components for transfusion, its remit spans the entire product lifecycle — from authorisation and licensing through manufacturing and supply oversight to post-market monitoring.
Regulatory-Grade Data
The paper explains that regulatory decisions affecting patient safety and public health must be supported by high-quality, regulatory-grade data.
According to the MHRA, there is no single universal definition of regulatory-grade data. However, data suitability for regulatory use depends on:
intrinsic quality and integrity;
fitness for the intended regulatory purpose;
representativeness of the population served.
The MHRA also highlights that regulatory-grade data must be assessed in context, since a dataset that is appropriate for one regulatory question may not be suitable for another.
Data Needs for Safety and Surveillance
The paper focuses on the MHRA’s need for access to longitudinal, timely, linked and representative patient-level data.
These data are important for post-market surveillance, including the detection and assessment of safety issues associated with medical products and the evaluation of the effectiveness of regulatory actions.
The MHRA notes that real-world use can reveal uncommon adverse effects, long-latency effects or effects in subpopulations that may not have been represented during pre-authorisation stages.
For medical devices, the paper highlights that real-world data are often incomplete. Exposure data may be inconsistently recorded, which can make safety monitoring more challenging. The MHRA identifies the universal introduction of the Unique Device Identifier (UDI) as an important step toward linking device exposure data with patient outcomes.
Opportunities for Future Regulatory Approaches
The MHRA considers that better access to rich, linked health data could support new regulatory approaches, particularly where randomised clinical trials may be impractical or unethical.
The paper states that a future HDRS could provide a single, trusted gateway to UK health datasets and support improved access to data for regulators, researchers, clinicians and industry.
The MHRA also notes that improved data infrastructure could help support earlier and more flexible approvals, while maintaining rigorous evidence standards.
Impact on Medical Device and IVD Manufacturers
For medical device and IVD manufacturers, the paper reinforces the growing importance of real-world data, post-market surveillance and device traceability in regulatory decision-making.
Manufacturers should pay particular attention to:
the quality and completeness of post-market data;
the ability to link device use with patient outcomes;
UDI implementation and structured recording of device identifiers;
evidence generation across the full product lifecycle;
the representativeness of data used to support regulatory claims;
the role of real-world evidence in safety, performance and ongoing benefit-risk evaluation.
Although the paper is not limited to medical devices, it highlights a key challenge for the sector: without reliable device exposure data and linked outcome data, regulatory surveillance may be constrained. For manufacturers, this underlines the importance of robust post-market systems and high-quality data strategies.
