MDCG Issues Addendum to Guidance Document MDCG 2022-18
30 June 2023
List of MDR & IVDR Harmonized Standards Updated
10 July 2023The MHRA has published its 2023-2026 Corporate Plan: HERE
General Overview
The overview covers a variety of topics, including the MHRA’s plans for improving response timeframes and increasing their ability to support innovative devices.
International Recognition
In addition to the above, the MHRA provided an update regarding their plan to establish equivalency routes for “trusted regulators”, such as the US FDA.
The timing for this project is slotted for 2024-2025, with the aim to complete it by 31 March 2025. The full extract is below.
“Year 2: 2024/25 (to be completed by 31 March 2025):
Improve patient access by formalising new recognition pathways for UK approval that complement our national routes to market and that provide a legal base to allow for expedited access for some medicines and medical devices where these have already been approved by trusted regulators.”
Casus will be monitoring for future updates on this topic.
