United Kingdom · Medicines and Healthcare products Regulatory Agency · Medical devices
Review target
-
Not published
Legal time limit
-
Not published
Steps
5
7 requirements
Application fee
£32,016
2025 to 2027 fee schedule
Medium and high-risk devices, and Class I devices that are sterile or measure, need a conformity assessment by a UK approved body. The body reviews clinical data, manufacturing and the quality system, then issues a UKCA certificate. The device is then registered with the MHRA. Class IIa, IIb and III devices, sterile or measuring Class I devices, and active implantable devices for Great Britain.
The clinical investigation notification, implantable or long-term invasive iib, class iii and active implantable (initial) is £32,016 for 2025 to 2027 fee schedule.
1. Classify the device; 2. Clinical investigation notice (60 days); 3. Approved body conformity assessment; 4. UKCA mark and registration; 5. Placing on the market and surveillance.
Outcome: A UKCA certificate and a registered device for the Great Britain market.
Legal basis: Medical Devices Regulations 2002 (SI 2002/618, as amended), Parts II and III
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).
About 60 days end to end with the official step targets. Targets, not actual times.
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 |
|---|---|
| Clinical investigation notification, implantable or long-term invasive IIb, Class III and active implantable (initial)Other · 2025 to 2027 fee schedule | £32,016 |
| Clinical investigation notification, Class I, IIa or non-implantable IIb (initial)Other · 2025 to 2027 fee schedule | £15,309 |
Other routes in United Kingdom: Device with an ancillary medicinal substance, Class I devices: self-declaration and registration, CE marked devices in Great Britain, General IVDs: self-declaration and registration, Self-test, List A and List B IVDs: approved body assessment. 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 (18 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.