Health Minister Baroness Merron last week announced in Parliament that MHRA fees will be set at £300 per year, based on Level 2 GMDN terms. This will take effect from 1 April 2026 to fund the MHRA’s post-market surveillance (PMS) activities. Overall, this move has been welcomed by BIVDA members.
We were glad that the MHRA reconsidered the initial fees model following BIVDA’s evidence, cited by Shadow Health Minister Lord Kamall, that some manufacturers faced cost increases of 5,000%. This represents a significant success for our sustained advocacy, as drastic cost increases would have been unsustainable for many companies, especially to SMEs that predominantly make up the IVD market.
Concerns regarding the transparency of GMDN level 2 term use remain and pose a challenge, especially for UKRPs and distributors, when discussing likely registration costs with foreign manufacturers before entering the UK market. Registration fees and other cost recovery measures remain key factors when companies review the business case for placing and maintaining a product on the UK market, especially for IVDs for rare diseases that may see low sales volumes and slim margins. Long-term clarity and certainty of these costs are important to company decision-making, especially as IVDs tend to have long product life cycles and some products require significant business investment to support.
BIVDA are aware that the Department of Health and Social Care continues to support MHRA with its Post Market Surveillance costs, and any future increase in the fee beyond inflation is likely to prompt companies to review the business case for keeping low-volume, low-margin products on the market. Continued uncertainty in this area will continue to affect members’ ability to plan and budget for these future costs.
The MHRA registration fee is just one cost in the process of registering an IVD product for the UK market. We support the MHRA proposal to introduce international recognition pathways to bring products to the UK market as well as the UK Conformity Assessment route and Innovation pathways. We welcome the future consultation planned regarding continued CE recognition, all of which help reduced duplicative costs and makes the UK a more attractive to place IVDs that meet patient needs.
BIVDA Chief Executive, Helen Dent, said: ‘We welcome the Minister’s announcement and are pleased that the MHRA has listened to the evidence put forward by BIVDA and our members.
‘However, greater clarity is required to remove ongoing uncertainty that risks undermining planning, as well as the availability of low-volume IVD products for patients on the basis of unsustainable fees.’
