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Dear members,

BIVDA held a joint in-person workshop with the MHRA on the future IVD Roadmap. This took place on 10 February at the MHRA offices.

The aims of this were to understand:

  • The IVD ecosystem
  • The gaps in the landscape
  • MHRA’s role in this
  • The needs for pre-market support
  • The barriers and enablers for market access

The workshop was very well attended, spanning representatives from government departments, industry experts, and MHRA themselves.

The conversations throughout the day centred around the opportunities for the industry and how government bodies could alleviate potential barriers to build a world-class IVD landscape.

Discussions included capacity issues, communication, the responsibilities of the different stakeholders, and how to optimise the regulatory pathway. MHRA, NICE, HTW and SHTG are working on the Innovative Devices Access Pathway (IDAP) which hopes to streamline the regulatory process for innovative devices meeting specific clinical needs.

Two key takeaways are that there should be transparency throughout the entire ecosystem, and a simplified, connected network of those involved in the processes.

BIVDA will work with MHRA on the next steps from this workshop and keep members engaged throughout.

Ben Kemp