MHRA-NICE Real-World Evidence Scientific Dialogue Opens to Medical Device Applications
The Medicines and Healthcare products Regulatory Agency has updated its corporate report on the MHRA-NICE Real-World Evidence Scientific Dialogue.
The programme is designed to support structured discussion on real-world evidence and now accepts applications relating to RWE and medical devices, with representation from Approved Bodies in relevant workshops.
Background to the Programme
In 2025, the MHRA conducted a pilot Real-World Evidence Scientific Dialogue programme to assess whether early, structured regulatory engagement could support better evidence generation.
The pilot aimed to foster collaboration between regulators and applicants, supporting robust decision-making for both regulatory and health technology assessment purposes.
During the pilot, four applicants participated in closed-door confidential meetings with MHRA and in a precompetitive “safe harbour” workshop jointly convened by MHRA and NICE.
Value of Early Dialogue
The pilot demonstrated the value of early dialogue, highlighted the need for clearer regulatory expectations and showed the benefits of workshop-based engagement for aligning stakeholders.
Following the pilot, MHRA is continuing RWE Scientific Dialogue through ongoing workshops and is exploring the integration of RWE advice into existing MHRA services. This supports MHRA’s Data Strategy ambition to promote data-driven innovation, early access to innovative products and proactive approaches to safety surveillance.
Aims of the Scientific Dialogue
The programme aims to enable strategically focused discussions on RWE through precompetitive “safe harbour” workshops.
According to the report, the workshops are intended to explore appropriate study designs, data sources and analytical methodologies to support high-quality RWE generation.
The programme also aims to clarify and promote consistency in regulatory and HTA expectations for RWE, while increasing transparency and shared learning across the ecosystem.
Structure and Timelines
Up to four workshops will be conducted each year, organised into two application cycles, with two workshops scheduled per cycle.
Selected applicants will be invited to a precompetitive workshop jointly convened by MHRA and NICE, with Approved Bodies represented for device-related applications. An optional follow-up meeting may also be offered.
The MHRA states that it will not charge fees for MHRA-NICE RWE Scientific Dialogue workshops.
For the current cycle, expressions of interest are no longer being accepted. Applicants are expected to be notified of outcomes in the first week of October 2026, with workshops hosted in November 2026. The second 2026 submission cycle is expected to launch in November 2026.
Eligibility and Selection
The MHRA welcomes expressions of interest for proposals with a specific focus on RWE.
For the purposes of the programme, Real-World Data is defined as data relating to patient health status and/or delivery of healthcare collected outside of a clinical study, while Real-World Evidence is evidence derived from the analysis of RWD.
Up to two applications will be selected per submission cycle. Priority will be given to proposals addressing cross-cutting RWE questions, shared learning, guidance development, MHRA and NICE public health and innovation priorities, and robust methodologies relevant across regulatory, HTA and NHS decision-making.
Impact on Medical Device Manufacturers
For medical device manufacturers, the expansion of the MHRA-NICE RWE Scientific Dialogue to device-related applications is highly relevant.
Manufacturers should pay particular attention to:
real-world evidence generation strategies;
real-world data sources;
study design and analytical methodology;
regulatory and HTA expectations;
Approved Body involvement in relevant workshops;
evidence planning across the product lifecycle;
NHS decision-making requirements;
public health and innovation priorities;
transparency and shared learning outputs;
opportunities in future submission cycles.
For manufacturers developing innovative medical devices, the programme may provide a valuable opportunity to discuss RWE approaches earlier and align evidence generation with regulatory, HTA and healthcare system expectations.
