United Kingdom · Medicines and Healthcare products Regulatory Agency · Medical devices
Review target
-
Not published
Legal time limit
-
Not published
Steps
4
6 requirements
Application fee
-
Makers of low-risk Class I devices that are not sterile and have no measuring function declare conformity themselves, affix the UKCA mark and register the device with the MHRA. No approved body is involved. Class I general medical devices without a sterile or measuring function, including qualifying software.
1. Classify the device; 2. Self-declaration and UKCA mark; 3. Register with the MHRA; 4. Placing on the market and surveillance.
Outcome: A UKCA-marked device registered with the MHRA for the Great Britain market.
Legal basis: Medical Devices Regulations 2002 (SI 2002/618, as amended), Part II
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 |
|---|---|
| No fees published. |
Other routes in United Kingdom: Device with an ancillary medicinal substance, UKCA marking with a UK approved body, 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 (13 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.