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What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
How to get information including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).
How to interpret post-market surveillance (PMS) requirements for medical devices in Great Britain.
The new set of regulations The Medical Devices (Post-market Surveillance…
Requirements of the manufacturers PMS system (Regulations 44ZE, 44ZF,…
Reporting under the GB Medical Devices Vigilance System (Regulations 44ZC,…
How to register your medical devices with the MHRA for the markets in Great Britain and Northern Ireland.
Guidance on the safe and effective use of GLP-1 medicines for weight loss and diabetes.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
How to manage and use bed rails safely.
Information about the reproductive risks of taking valproate medicines and the measures in place to reduce potential harm.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
Sets out medicines that cannot be exported from the UK or hoarded because they are needed for UK patients.
Information and recommendations for approved bodies on the presentation and review of a periodic safety update report (PSUR).
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
How to contact the MHRA for specific services or enquiries.
How to apply for a clinical trial from 28 April 2026, including eligibility, phases, model IMPDs, costs and how to make changes to your application.
How to apply for, update and cancel licences for the manufacture, import and wholesale of human and veterinary medicines.
How to package medicines for sale and what information you must provide to consumers and healthcare professionals.
An overview of the process including submitting or fast-tracking an application, naming your medicine and paying fees.
Guidance on the collection, verification, and reporting of safety events in clinical trials of an investigational medicinal product.
How to get access to MHRA submissions portals, how to use them, where to go for help.
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