United Kingdom · Medicines and Healthcare products Regulatory Agency · Diagnostics (IVD)
Review target
-
Not published
Legal time limit
-
Not published
Steps
4
7 requirements
Application fee
-
Higher-risk IVDs need a UK approved body. Self-test IVDs need a design examination. List A and List B IVDs need quality system audits or type examination, and List A batches are verified before release. IVDs for self-testing, and IVDs on Annex II List B (for example rubella tests and blood sugar self-tests) or List A (for example HIV and hepatitis tests and blood grouping).
1. Categorise the IVD; 2. Approved body assessment; 3. Batch verification for List A; 4. UKCA mark and registration.
Outcome: A UKCA-marked IVD registered with the MHRA.
Legal basis: Medical Devices Regulations 2002 (SI 2002/618, as amended), Part IV, regulation 40
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: Class I devices: self-declaration and registration, UKCA marking with a UK approved body, CE marked devices in Great Britain, General IVDs: self-declaration and registration. 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 (14 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.