United Kingdom · Medicines and Healthcare products Regulatory Agency · Combination products
Review target
-
Not published
Legal time limit
-
Not published
Steps
4
3 requirements
Application fee
£50,644
2025 to 2027 fee schedule
A device that includes a medicinal substance with a supporting (ancillary) action, such as a heparin-coated catheter, is regulated as a class III device. The approved body must consult the MHRA on the substance. Integral single-use drug-device products, such as pre-filled syringes, are licensed as medicines instead. Devices whose main action is physical but that contain a medicinal substance with ancillary action.
The mhra consultation, device with a new active substance (initial) is £50,644 for 2025 to 2027 fee schedule.
1. Decide the regulatory route; 2. Approved body conformity assessment; 3. MHRA consultation on the substance; 4. UKCA marking and registration.
Outcome: A UKCA-marked class III device, registered with the MHRA.
Legal basis: Medical Devices Regulations 2002 (SI 2002/618), Part II; Human Medicines Regulations 2012 for integral drug-device products
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
Official step durations
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| MHRA consultation, device with a new active substance (initial)Other · 2025 to 2027 fee schedule | £50,644 |
| MHRA consultation, device with a known substance from a new source (initial)Other · 2025 to 2027 fee schedule | £11,543 |
| MHRA consultation, device with a known substance from an approved manufacturer (initial)Other · 2025 to 2027 fee schedule | £4,953 |
Other routes in United Kingdom: Innovative Licensing and Access Pathway (ILAP), Class I devices: self-declaration and registration, UKCA marking with a UK approved body, CE marked devices in Great Britain. See all routes on the United Kingdom page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (13 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.