The MHRA’s recent fees consultation contains a proposal to charge annual fees, per GMDN code. If implemented, this would significantly increase costs for the IVD industry – to the point were some products are likely to be commercially unviable. While BIVDA understand the MHRA’s intention for industry to fund its activities, this proposal is likely to mean large price rises for products which will be passed to the consumer – another arm of the government.
BIVDA work closely with the MHRA and have already made them aware of our concerns. We have formally requested the MHRA’s cost modelling and will be engaging with other parts of government and politicians to ensure wider government is aware of the impact this proposal will cause.
We have already received evidence from members about the potential impact. If you would like to add to our consultation response, please email regulatory@bivda.org.uk.
