MHRA brings together real-world evidence knowledge and guidance

What Changed

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a page introducing its Real-World Evidence Knowledge and Guidance Hub.

The hub brings together MHRA guidance, publications and resources on real-world data (RWD) and real-world evidence (RWE). Its scope covers their use in UK regulatory decision-making for medicines and medical devices.

Who Is Affected

The intended audience includes researchers, healthcare professionals, industry, patients and other stakeholders interested in generating and using RWE.

Medical-device stakeholders are therefore within the stated audience, although the hub is not limited to devices: it also covers medicines.

Regulatory and Technical Implications

MHRA defines RWD as data relating to patient health status or the delivery of healthcare collected outside a clinical study. Information produced by analysing those data may be referred to as RWE.

The announcement explains these concepts and the hub’s purpose. It does not set out detailed criteria for regulatory acceptance of a particular dataset or body of evidence.

Manufacturer Actions

Medical-device manufacturers interested in RWD and RWE can use the hub as an information source for relevant MHRA guidance and publications.

The supplied announcement does not specify new submission, reporting or technical-documentation obligations. Publication of the hub should not, on this text alone, be interpreted as a new compliance requirement.

Confirmed Dates

The source page states a publication date of 9 October 2026. The supplied text gives no separate implementation date, transition period or compliance deadline.

Official Source

MHRA’s GOV.UK page, “MHRA Real-World Evidence: knowledge and guidance”, describes the hub’s purpose and audience and lists an HTML document with the same title.

https://www.gov.uk/government/publications/mhra-real-world-evidence-knowledge-and-guidance