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How to conform with the legal requirements for placing medical devices on the market.
Guidance on the Ionising Radiation (Medical Exposure) Regulations 2017 for employers and health professionals who carry out medical radiological procedures.
Guidance on manufacturing, importing, distributing and supplying specially manufactured or ordered products, including cannabis-based products for medicinal use in humans (CBPMs), known as 'specials'
How to get access to MHRA submissions portals, how to use them, where to go for help.
Details of the system for reporting adverse drug reactions from medicines or adverse incidents with medical devices in the UK
Guidance on labelling for medicinal products used in clinical trials.
Information on when software applications (apps) are considered to be a medical device and how they are regulated.
A summary of the types of scientific advice available at the MHRA, the process for getting advice and the fees involved.
Sets out deliverables and timelines to support the development of safe In Vitro Diagnostic (IVD) medical devices.
Guidance on the collection, verification, and reporting of safety events in clinical trials of an investigational medicinal product.
How to interpret post-market surveillance (PMS) requirements for medical devices in Great Britain.
Pharmacy (P), prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
Guidance on the various types of modifications that can be made to a clinical trial approval.
Sets out the payment due from members of the voluntary scheme for branded medicines pricing, access and growth in 2026.
Guidance on the MHRA’s national assessment procedure for marketing authorisation applications.
How to apply for a clinical trial from 28 April 2026, including eligibility, documentation and registration in a public registry.
Patient factsheet to provide information on vaccines and vaccine safety.
Details of the organisations that are currently approved to undertake conformity assessments on medical devices.
How to apply for a regulatory advice meeting on medical devices and in vitro diagnostic devices.
How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.
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