MHRA updates guidance on the Health Institution Exemption to support safe use of medical devices
Updated MHRA guidance will help health institutions, such as NHS Trusts and Boards, safely design and make general medical devices for patients.
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Guidance: Medical devices: legal requirements for specific medical products
Information for manufacturers on the regulations that apply to prosthetic, orthotic and ophthalmic devices.
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Guidance: Health Institution Exemption for general medical devices
Guidance for health institutions that manufacture general medical devices under the Health Institution Exemption (HIE).
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Professor Bola Owolabi CBE: Creating the Climate for Health Equity
Exploring the MHRA’s transformational impact on access, experience, and outcomes.
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Official Statistics: Quarterly reports on the import of unlicensed medicines
Details and statistics on the import of unlicensed medicines from March 2014 onwards.
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Medical devices: conformity assessment and the UKCA mark
How to conform with the legal requirements for placing medical devices on the market.
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UK approves the first twice yearly biological medicine for asthma and severe chronic rhinosinusitis with nasal polyps
As with any medicine, the MHRA will keep the safety and effectiveness of depemokimab under close review.
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MHRA welcomes Professor Jonathan Benger CBE as new CEO of NICE
Professor Benger’s leadership comes at a pivotal time as the MHRA and NICE deepen collaboration
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European first as MHRA approves over-the-counter allergy treatment for adolescents aged 12 and over
As with any medicine, the MHRA will keep the safety and effectiveness of fluticasone propionate under close review.
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Guidance: Medical devices: list of UK approved bodies
Details of the organisations that are currently approved to undertake conformity assessments on medical devices.
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Class 3 Medicines Recall: Activase Pharmaceuticals Limited, Prednisolone 5mg Soluble Tablets, EL(25)A/54
Activase Pharmaceuticals Limited is recalling two batches of Prednisolone 5mg Soluble Tablets as a precautionary measure due to a limited number of reports of blister pockets becoming swollen over time.
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Field Safety Notices: 8 – 12 December 2025
List of Field Safety Notices from 8-12 December 2025