MHRA-NICE Real-World Evidence Scientific Dialogue Now Accepts Medical Device Applications

The Medicines and Healthcare products Regulatory Agency, MHRA, has updated the MHRA-NICE Real-World Evidence Scientific Dialogue corporate report.

The publication was updated on 4 September 2026 and describes the continuation of the Real-World Evidence Scientific Dialogue following the 2025 pilot programme.

Background

In 2025, the MHRA conducted a Real-World Evidence Scientific Dialogue programme, or RWE SDP, pilot to assess whether early, structured regulatory engagement could support better evidence generation.

The pilot was intended to foster collaboration between regulators and applicants and support robust decision-making for both regulatory and health technology assessment, or HTA, purposes.

Pilot Programme

During the pilot, four applicants participated in closed-door confidential meetings with the MHRA and a precompetitive “safe harbour” workshop jointly convened by MHRA and NICE.

The confidential meetings addressed product-specific and commercially sensitive RWE topics across different disease areas and stages of the product lifecycle. The workshop focused on challenges and opportunities in using Real-World Data, or RWD, for rare diseases in regulatory and HTA assessments.

Value of Early Dialogue

MHRA states that 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 that enable open discussion on RWE topics while exploring integration of RWE advice into existing MHRA services.

Expansion to Medical Devices

A key update is that the MHRA-NICE RWE Scientific Dialogue will now accept applications relating to RWE and medical devices.

The report also states that Approved Bodies will be represented in relevant workshops.

This makes the programme particularly relevant for medical device manufacturers exploring how real-world data and real-world evidence may support regulatory and HTA decision-making in the UK.

Aims of the Programme

The programme aims to enable strategically focused discussions on RWE through precompetitive safe harbour workshops.

These 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 by consolidating methodological principles, evidentiary standards, key decision points and common challenges.

A further aim is to increase transparency and shared learning by translating workshop discussions into publicly shareable outputs developed with partners, including NICE.

Structure and Timelines

Up to four workshops will be conducted each year, organized 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. For device-related applications, Approved Bodies may be represented. An optional follow-up meeting may also be offered.

For the current cycle, MHRA is no longer accepting expressions of interest. Applicants are expected to be notified of the outcome during the first week of October 2026, and workshops are expected to be hosted in November 2026.

MHRA states that it will not charge fees for MHRA-NICE RWE Scientific Dialogue workshops.

Eligibility

MHRA welcomes expressions of interest related to any proposal with a specific focus on RWE.

For this programme, Real-World Data is defined as data relating to patient health status and/or delivery of healthcare collected outside a clinical study. Real-World Evidence is defined as evidence derived from the analysis of RWD.

Expressions of interest will be excluded if they involve products currently undergoing GB or UK regulatory or HTA procedures, or if they are already in an MHRA pathway or process such as ILAP or AI Airlock.

Selection Process

Up to two applications will be selected per submission cycle.

Priority will be given to workshop proposals that address cross-cutting RWE questions, support shared learning and guidance development, align with MHRA and NICE public health and innovation priorities, and explore methodologically robust approaches relevant across regulatory, HTA and NHS decision-making.

Applications not selected may still seek advice through existing MHRA and NICE scientific advice services and pathways.

Impact on Medical Device Manufacturers

For medical device manufacturers, the update is significant because it brings device-related RWE proposals into the MHRA-NICE Scientific Dialogue framework.

Manufacturers should pay particular attention to:

• RWE strategy and evidence-generation planning;

• appropriate RWD sources;

• study design and analytical methodology;

• alignment with regulatory and HTA expectations;

• cross-cutting RWE questions;

• relevance to NHS decision-making;

• Approved Body involvement in device-related workshops;

• exclusion criteria for products already in regulatory or HTA procedures;

• public learning outputs from workshops;

• potential use of existing MHRA and NICE advice routes where not selected.

For companies developing or commercializing medical devices in the UK, the key message is that early, structured dialogue on RWE may help clarify expectations and support stronger evidence planning across regulatory, HTA and healthcare decision-making contexts.