MHRA Real-World Evidence Scientific Dialogue Programme
Page summary:
A programme to help decision-making across the lifecycle of products, benefitting both regulatory and health technology assessment (HTA) evaluations.
Change made:
Changed to add download link to Expression of Interest for the MHRA Real-World Evidence Scientific Dialogue Programme pilot
Time updated:
12:01am, 10 February 2025
Digital mental health technology: qualification and classification
Page summary:
Helping manufacturers define the characteristics of their devices and determine the appropriate regulatory qualification and classification.
Change made:
Guidance document replaced with version 1.1 which has changes to the wording of Example 6 (p17) and Example 14 (p46)
Time updated:
11:22am, 13 February 2025
Medical devices given exceptional use authorisations during the COVID-19 pandemic
Page summary:
List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled.
Change made:
Extensions issued for:DEU/010/2023/002 – AxiomTM Total Blood Typing Solution/Gene Titan™ Multi-Channel Instrument SystemDEU/002/2024/002 – Integrated Analysis Package (IAP) software
Time updated:
5:09pm, 12 February 2025
