The Medicines and Healthcare products Regulatory Agency (MHRA) published an update to the Government Response to the MHRA Consultation on Statutory Fees for medical devices yesterday.
This follows a consultation in 2024 which proposed fee increases which would have made many in vitro diagnostic products unviable for the UK market. BIVDA were supported by members to respond to the consultation and clearly evidence the effect it would have on our industry.
The response outlines proposals to introduce a new annual fee to support post-market surveillance (PMS) activities for medical devices.
The new fee structure will come into effect from 1 April 2026, with further guidance and support to be published in the coming months to help the IVD industry to prepare. Key takeaways are:
- The new PMS fee will be based on GMDN level 2 categories (or Level 1 Category where no Level 2 exists), rather than the more granular level 5.
- The new fee will replace the current one-off registration fee of £261 and will be effective from 1 April 2026 for all devices registered.
- The estimated fee is £300 from 1 April 2026, per GMDN level 2 category (or Level 1 Category where no Level 2 exists), with approximately 60% of manufacturers estimated by the MHRA to pay only a single charge.
- All fees will continue to be paid though the MHRA’s Device Online Registrations System (DORS), payable by either Worldpay or BACS/CHAPS.
BIVDA’s Head of Regulatory Strategy, Professor Mike Messenger says, “While any increase in fees is challenging for our members, we welcome this response and are pleased that MHRA have listened carefully to industry feedback. The revised fee structure, based on higher-level categories, is far more equitable and avoids the disproportionate impact that the original proposal would have had on IVD manufacturers.
“The original proposal risked fewer critical IVDs being available to patients, higher costs for the NHS, and ultimately worse outcomes. This more balanced approach better supports SMEs and safeguards patient access. BIVDA will continue to work with MHRA to ensure that any future fee changes remain proportionate and sustainable.”
Neil Plumridge, Regulatory Affairs Manager, comments, “It is good news that the fees are staying relatively low. However, it is unclear how many members may be forced to pay for multiple codes, causing a significant cost increase. We will be issuing bespoke communications to members via our regulatory channels, and discussing these proposals at our next working party on the 18th September.”
