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BIVDA meet with MHRA’s senior leadership

By April 2, 2024No Comments

On Thursday 28th March, BIVDA’s Helen Dent, Mike Messenger, Stuart Angell and Paul Fisher met with Medicines and Healthcare products Regulatory Agency CEO Dame June Raine, co-chair Amanda Calvert, and members of their executive leadership.

The meeting is part of a series of bilateral meetings between the MHRA and BIVDA to provide a high-level update on the top-level activities of the two organisations.

The key topics of the meeting included:

  • IVD Roadmap, including the trusted advisor principles
  • GB Post Market Surveillance (PMS) SI
  • IVD classification rules
  • Innovative Device Access Pathway (IDAP)
  • International Recognition
  • The role of UK Approved Bodies under the new regulation

The meeting provided an opportunity for BIVDA to underline our view of balancing patient safety with proportionate use of regulation, and the need to clear guidance to enable a high probability of success for the GB market access, ultimately ensuring the UK being a key stepping stone onto the IVD international market.

BIVDA also presented our 2024-27 strategy to the MHRA, which was well received and identified a number of areas of alignment. It was extremely welcome to hear Dame June and colleague’s acceptance of the increasing importance of diagnostics, the MHRA’s role as an integral part of the health eco-system with partners, and their acceptance of the impact regulation has on industry and the UK economy.



Ben Kemp