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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 register your medical devices with the MHRA for the markets in Great Britain and Northern Ireland.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Sets out medicines that cannot be exported from the UK or hoarded because they are needed for UK patients.
How to apply for, update and cancel licences for the manufacture, import and wholesale of human and veterinary medicines.
How to manage and use bed rails safely.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
How to show the MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Guidance on the MHRA’s national assessment procedure for marketing authorisation applications.
An overview of the process including submitting or fast-tracking an application, naming your medicine and paying fees.
How to package medicines for sale and what information you must provide to consumers and healthcare professionals.
How to contact the MHRA for specific services or enquiries.
Details of the organisations that are currently approved to undertake conformity assessments on medical devices.
How to get access to MHRA submissions portals, how to use them, where to go for help.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
Details of the system for reporting adverse drug reactions from medicines or adverse incidents with medical devices in the UK.
The UK government has introduced the Northern Ireland MHRA Authorised Route (NIMAR). This new route for supply became operational 1 January 2022.
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