Part 1 What is Changing
To place medical devices onto the UK market manufacturers must register with the MHRA and register all relevant products, registration must be active when each batch of product is placed on the market. For manufacturers based outside the Uk this is done via the UKRP.
Currently, the fee structure for this process is based on registration activity, with a fee charged for each registration activity or session, this could be for a single product or several thousand products! Registrations are subdivided by the product’s specific GMDN code or ‘term’, of which there are hundreds. This fee is effectively a one-off fee, currently £261 per application. Once registered, no further fees have been payable unless changes to the registration are required.
Following a consultation exercise, the fee structure is fundamentally changing from 1st April 2026. From this date an annual fee will apply, initially set at £300, payable for all devices registered on 30th March each year.
How are the Fees Calculated
The good news is that the fee is not payable per device, and not even necessarily for each GMDN term. There is a hierarchy within the GMDN coding system, each product will have a GMDN code or ‘term’ based on physical characteristics and the intended purpose/function of the device. However, above these individual codes devices are grouped in a number of families. These families are termed ‘Device Function GMDN® Level 2 Categories’, and it is these categories that will determine how many fees will be due each year. So, if all your devices fall within one family, only one fee will be payable even if you have multiple products under multiple GMDN Terms.
In simplistic terms there are four dividing lines within the Level 2 categories:-
- Intended Purpose – similar products that have different intended purposes are likely to be in separate categories.
- Active vs Non-Active – devices with similar intended purposes but are classified differently here will be in different level 2 categories.
- Implantability – similarly if a device is implantable it will be in a separate category from one with a similar intended purpose that is not.
- Dual Registration as Procedure Packs and Individual Items – If the individual item is included within a procedure pack that is separately registered, these fall in two level 2 categories and therefore two fees will be payable.
The introduction of annual fees will allow much greater scope for making changes to registrations without incurring fees. Only if a new device is registered within a new level 2 category will a fee be charged and this will be pro rata of the annual fee, depending on the date of registration. Further details can be found on the MHRA website and in the document DORS_Fees_Guidance_2.1.pdf