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There are different regulations which apply to devices and equipment including hand gels and PPE (personal protective equipment)
Guidance for healthcare and social services organisations on managing medical devices in practice.
A weekly report covering adverse reactions to approved COVID-19 vaccines
This report covers the period 9 December 2020 to 14 February 2021. Summary…
An interpretation of the good manufacturing practice (GMP) requirements for specials manufacturers.
List of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months af…
The different types of tests and testing kits for COVID-19, and the specifications for manufacturers.
Template for a blood bank compliance report and guidance on completing it.
Licences and regulations for organisations that handle human blood or blood products and reporting adverse incidents with blood through SABRE.
A list of authorised orphan medicinal products registered by the UK Licensing Authority.
Information for healthcare professionals and the public about the COVID-19 Vaccine AstraZeneca.
How to apply for marketing authorisation via this new procedure.
How to apply for the decentralised and mutual recognition reliance procedure (MRDCRP).
How to apply for the Unfettered Access Procedure (UAP).
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
List of field safety notices (FSNs) from medical device manufacturers from 15 to 19 February 2021
Public list of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked or suspended.
Information for healthcare professionals and the public about the COVID-19 Vaccine Moderna
The findings and recommendations of the Expert Advisory Group on paclitaxel drug-coated balloon catheters and drug-eluting stents which are used to treat patients with peripheral arterial disease.
The MHRA’s recommendations for using paclitaxel-coated devices in patients with intermittent claudication and critical limb ischaemia remains unchanged.
The home of Medicines and Healthcare products Regulatory Agency on GOV.UK. The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK.
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