Usage Examples
- We are going in on IRP off the EMA approval, so the reference regulator box is already ticked.
- MHRA registration has to be live before the first Great Britain shipment; a CE certificate alone does not put the device on the market.
- Northern Ireland sits on different device rules, so this filing only buys us Great Britain.
What is MHRA (Medicines and Healthcare products Regulatory Agency)?
MHRA is the United Kingdom's regulator of medicines, medical devices, and blood components for transfusion, granting UK authorisations through its own assessment or by recognising a named reference regulator, not through the EU centralised procedure.
MHRA exists because no manufacturer can be trusted to certify its own product to the patients who take it. The agency is the regulator of medicines, medical devices and blood components for transfusion in the UK, and its remit is to ensure those products meet applicable standards of safety, quality and efficacy, and to secure a safe supply chain for them.
MHRA covers those three product families across the whole UK, but the coverage is not uniform underneath. The rules for placing medical devices on the Northern Ireland market differ from those applicable to Great Britain, so there is no single UK device filing. MHRA registration is separately mandatory before Great Britain market entry, whatever conformity marking the device already carries.
MHRA reviews a UK marketing authorisation through one of two routes. The National Pathway is a full assessment. The International Recognition Procedure, introduced on 1 January 2024 to complement it, lets an applicant build on an approval already granted by a specified reference regulator. Even then MHRA runs a targeted assessment on the unredacted reference report and retains the authority to refuse.
Not to be confused with
- EMA
- EMA's centralised procedure produces an authorisation valid across the EU and EEA; MHRA's does not extend there, and an EMA approval does not itself licence a product in the UK. It only makes the product eligible to be recognised.
- UKCA marking
- a conformity marking a manufacturer applies to a device for the Great Britain market. MHRA registration is a separate, mandatory step; carrying a valid marking does not put the device legally on the market.
- The Northern Ireland market
- Northern Ireland device rules differ from Great Britain's, so "UK approval" is imprecise for devices. Scope your regulatory strategy to Great Britain or to Northern Ireland explicitly.
- Reliance vs recognition
- IRP is reliance on another regulator's assessment report, not automatic recognition of its decision. MHRA can still refuse an application that a reference regulator approved.
The obligations differ by product type. These are the anchors a UK filing is built on.
What you must do
- 1Demonstrate that the medicine, device, or blood component meets applicable standards of safety, quality and efficacy, whichever route is usedMHRA: About us - statutory objectives
- 2Confirm the existing approval came from a specified reference regulator (TGA, Health Canada, Swissmedic, HSA Singapore, PMDA, FDA, or EMA and Member State competent authorities) before claiming an IRP routeMHRA IRP guidance - reference regulators
- 3Supply the unredacted assessment report from the reference authority, because MHRA's targeted assessment is built on it and MHRA retains the authority to refuseMHRA IRP guidance - targeted assessment
- 4Register every medical device, including IVDs, custom-made devices, and systems or procedure packs, with MHRA before placing it on the Great Britain marketMHRA device guidance - Great Britain registration
- 5Plan Great Britain device compliance against the CE acceptance cut-off, which runs to 30 June 2030 at the latest and varies by device type and classificationMHRA device guidance - CE marking acceptance
Common mistakes
Assuming an FDA or EMA approval carries into the UK
it does not. A reference regulator approval only makes a product eligible for the International Recognition Procedure; MHRA still assesses it and can refuse. Teams that skip the UK filing find the product unsaleable in Great Britain on launch day.
Filing IRP with a redacted assessment report
MHRA's targeted assessment is built on the unredacted report issued by the reference authority. A redacted or withheld report removes the basis for the whole route, which forces a fall back to full national assessment and resets the timeline.
Treating CE acceptance as a registration exemption
the two are unrelated. Every device must be registered with MHRA before it is placed on the Great Britain market, and CE acceptance itself is time-limited, running to 30 June 2030 at the latest and earlier depending on device type and classification.
When This Matters
- We are going in on IRP off the EMA approval, so the reference regulator box is already ticked.
- MHRA registration has to be live before the first Great Britain shipment; a CE certificate alone does not put the device on the market.
- Northern Ireland sits on different device rules, so this filing only buys us Great Britain.
Frequently Asked Questions
MHRA regulates medicines, medical devices, and blood components for transfusion in the UK. Its statutory job is to ensure those products meet applicable standards of safety, quality and efficacy, to secure a safe supply chain for them, and to educate the public and healthcare professionals about their risks and benefits.
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