A new access point to existing resources
On 9 October 2026, the Medicines and Healthcare products Regulatory Agency (MHRA) first published its Real-World Evidence Knowledge and Guidance Hub. The collection covers real-world data (RWD) and real-world evidence (RWE) in UK regulatory decision-making for medicines and medical devices. The same-day update added a link to the agency’s data requirements publication, which was published on 2 July 2026.
The launch improves access to resources; it does not establish a new standalone technical framework for medical devices. The linked material includes guidance, draft guidance, research publications and regulatory science initiatives. Each resource retains its own date, status and intended scope. Inclusion in the hub should not be treated as a revision of the underlying document.
The hub also expressly qualifies its publication list. Listing a publication does not constitute MHRA endorsement of a particular product, organisation, study, data source, methodology or conclusion. Unless explicitly stated, inclusion should not be interpreted as regulatory advice, guidance, policy or a formal agency position.
Device evidence depends on identifiable exposure and outcomes
The MHRA describes RWD as patient health or healthcare delivery data collected outside a clinical study. Information derived from analysing such data may be described as RWE. The hub explains that suitability for a regulatory purpose depends on the question being addressed, the quality and suitability of the source, and the study’s design and conduct.
The July data requirements paper provides a device-specific illustration. Some registries capture procedural outcomes without sufficient device details; others hold device information but lack outcomes or covariates. The agency notes that inconsistent recording of device exposure can make it difficult to trace the product used to an individual patient and assess safety.
For developers considering routine records or registries, a practical implication is to assess whether the dataset can link the relevant patient, device exposure and outcomes at the level needed for the proposed claim. A large dataset of procedures may still be inadequate for a product-specific question. This is an interpretation of the evidence problem described by the agency, rather than a new submission checklist introduced by the hub.
The paper discusses structured recording of Unique Device Identifiers as a way to improve device exposure data. That discussion concerns data infrastructure and should not be presented as a new manufacturer implementation deadline arising on 9 October.
Apply the scope of each linked document
The collection’s overall coverage of medical devices does not make every linked guideline device-specific. For example, ICH M14 concerns non-interventional studies using RWD for the safety assessment of medicines. Other resources address randomised trials or external control arms and must be read with their own scope and draft or final status. General principles may inform device evidence planning, but medicine-specific procedures should not be transferred directly into a device submission.
The hub links to the MHRA’s regulatory advice meeting service for medical devices and IVDs. That service can help clarify the application of existing regulations where guidance is not straightforward. It does not replace formal structured dialogue with an approved body and cannot provide tailored design or development consultancy for a product that the MHRA or an approved body will assess.
The immediate benefit is therefore a clearer route to relevant information. Whether RWE can support a particular device remains a product- and question-specific assessment grounded in the applicable resource and the actual capabilities of the dataset.
Sources
- Primary official sourceMHRA Real-World Evidence: knowledge and guidance (opens in a new tab)Medicines and Healthcare products Regulatory Agency
- Supporting sourceMHRA Real-World Evidence: knowledge and guidance — resource hub (opens in a new tab)Medicines and Healthcare products Regulatory Agency
- Supporting sourceMHRA data requirements to support regulatory decision making (opens in a new tab)Medicines and Healthcare products Regulatory Agency
- Supporting sourceMedical devices: ask for a regulatory advice meeting from the MHRA (opens in a new tab)Medicines and Healthcare products Regulatory Agency