United Kingdom · Medicines and Healthcare products Regulatory Agency · Medical devices
Review target
-
Not published
Legal time limit
-
Not published
Steps
4
8 requirements
Application fee
-
Great Britain accepts CE marked devices for a set time. Devices under the EU MDR or IVDR can be placed on the market until 30 June 2030. Older EU directive devices have earlier end dates. Registration with the MHRA is still required. Devices and IVDs that already carry a valid CE marking under EU rules.
1. CE marking under EU rules; 2. Appoint UK responsible person; 3. Register with the MHRA; 4. Placing on the Great Britain market.
Yes. It relies on approvals from European Union (recognition).
Outcome: The CE marked device can be placed on the Great Britain market after registration.
Legal basis: Medical Devices Regulations 2002 (SI 2002/618, as amended), transitional provisions for CE marked devices
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, Class I devices: self-declaration and registration, UKCA marking with a UK approved body, 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 (16 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.