ELISA 96 well plate showing graduated standard curve in triplicate and patient samples in duplicate. Wells are various shade of yellow which is proportional to the amount of analyte detected.

New fees from UK regulator could push up costs of medical tests

Once again, British medical diagnostic companies are being asked to dig deeper into their pockets to fund the medical devices approval and monitoring work of MHRA, the UK regulator for medicines and medical devices.

All medical devices sold and marketed in the UK, including medical diagnostic tests, are required by law to be approved by, and registered with MHRA in a centralised publicly-accessible database.

Costs of MHRA registration to soar

Medical diagnostic companies are likely to see the cost of registering their products with MHRA to soar next year in an effort by the regulator to recoup some of their costs policing the medical device industry. Some of the proposed changes include a hike in the registration fees charged to medical device companies, which includes diagnostics companies, and making these charges an annual fee, rather than a one-time fee paid at the time of the original registration.

The justification for this is to cover the cost to MHRA of the increased regulatory burden placed on both manufacturers and regulators by the new Medical Device Regulations, which rightly will now cover monitoring the safety of devices throughout the product’s life cycle, rather than just approving it to be initially placed on the market. However,the proposed flat rate fees per type of device, known as a GMDN code, does not take into account the risks posed by the device, or the size of the company, so it will cost the same to register and maintain the registration of a simple pregnancy test as a hip replacement joint or heart pacemaker.

Unfairly affecting the most innovative medical companies

The British In Vitro Diagnostics Association (BIVDA) which is the trade body for UK diagnostics manufacturers said, “These proposed increases will disproportionately impact SMEs - the sector that the government and NHS recognise as a key part of the UK health economy. Given the MHRA has had challenges meeting its targets, particularly with regards to clinical trials, any increase is doubly unwelcome.”

The proposed new fee structure is likely to significantly affect smaller medical diagnostic companies, which fuel innovation in this sector. This is due to the relatively large and diverse number of categories of products manufactured by diagnostic companies, albeit relatively low value, compared to other types of medical device manufacturers, and each type of test needing a separate registration with MHRA. If the proposed changes go ahead, a small diagnostics company with just 100 products is likely to face an additional annual registration fee of at least £21,000, and a proportional increase in workload and costs for the company to administer the registrations each year.

What does this mean for the future development of new diagnostics in the UK?

If the proposals go ahead as planned, some SMEs may decide to cease the R&D and production of more specialised diagnostics due to the increased financial burden, resulting in less competition between manufacturers for NHS labs to purchase their tests from. Most diagnostic companies will have no alternative but to increase the prices they charge the NHS for their tests, so at the end of the day there may not be any net financial gain for the government in increasing the fees that MHRA already charges.

Further information

SELFCHECK is a range of medical self-testing kits assembled in the UK according to an ISO13485:2016 certified quality assurance system. The range is available from key UK retailers and also directly from selfcheckmedical.com
For further information please contact SELFCHECK.
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