On 16 October 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance on medical device registration fees, confirming an annual fee exemption for eligible medical devices that are put into service only. This article summarises the typical exempt scenarios, the fee rate and payment deadline for the 2026/2027 charging year, and provides a checklist for organisations with registration obligations in the UK.
1. Which devices may qualify for the exemption?
MHRA guidance gives the following typical examples of devices that are put into service only:
1. In vitro diagnostic devices (IVDs)
For example, a test reagent developed in-house by an NHS laboratory and used only for patient testing within that organisation, without being distributed on the market.
2. Software as a medical device (SaMD)
For example, medical software developed by a hospital that can be accessed and used only on that hospital’s premises and is not distributed on the market.
3. Sterile services and surgical instrument sets
For example, a sterile services department serving hospitals within the same NHS Trust, or a hospital producing surgical instrument sets solely for its own use.
4. Custom-made wheelchair cushions
For example, a wheelchair cushion made by a healthcare provider solely for use by its own patients.
5. Custom-made orthoses
For example, an orthosis custom-made for a patient and supplied or fitted at the manufacturer’s premises in circumstances covered by the guidance, without being distributed on the market.
6. Custom-made facial prostheses
For example, a facial prosthesis made by a hospital’s maxillofacial surgery department for a specific patient and fitted at the same premises.
7. Custom-made dental implants
For example, a dental implant made by a private hospital solely for use by its own patients.
These are specific scenarios listed or described in MHRA guidance. They do not mean that every device in the same category automatically qualifies for the annual fee exemption. Eligibility depends on how the device is actually manufactured, supplied, delivered and used.
2. Annual fees for 2026/2027
| Item | Details |
|---|---|
| Charging period | 1 April 2026 to 31 March 2027 |
| Fee | GBP 300 per year for each chargeable GMDN Level 2 category; where no applicable Level 2 category exists, the fee is calculated using the Level 1 category |
| Payment deadline | Outstanding annual fees covered by this update must be paid by 6 November 2026, as required in the MHRA notice |
| Fee calculation | The final amount payable is based on the recalculation in MHRA’s Device Online Registration System (DORS) |
3. Implications for medical device companies
Companies should assess whether the relevant devices genuinely meet MHRA’s conditions for putting into service only, log in to DORS to check the recalculated amount due for 2026/2027, and pay by the deadline to avoid the additional risks associated with late payment.