The MHRA recently announced a consultation on their statutory fees, running until 24th October.
BIVDA have significant concerns about the suggestion of charging per GMDN code. As drafted, this could see fees increasing dramatically – from low hundreds of pounds to tens of thousands annually.
The current regulatory transition may also see duplicate charging, where the same device is currently transitioning between regulatory regimes and there are duplicate entries under the different regulations using the same GMDN Code. For a single assay, there may be multiple GMDN codes associated with the individual components required to run the assay e.g. reagent, calibrator, control materials, etc. potentially resulting in multiple fees for a single platform.
Beyond the financial impact, this will discourage innovation, impact IVD development for rare diseases and/or pandemic preparedness, and ultimately see products removed from the market. The effect will be disproportionately felt by SMEs – the opposite of the government’s plans to encourage economic growth and support SMEs.
A number of members have already replied to our request for impact assessments, which has been extremely helpful. We would ask all members to assess the increase in costs, and what effect this would have, to inform our response.
BIVDA enjoy an excellent relationship with the MHRA, and as well as responding to the consultation we will directly engage the MHRA. We will also be writing to the relevant minister, and looking to assess what the actual cost of regulating IVDs to the MHRA is. We will be focussing on this topic at our next regulatory affairs working group in October.
