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How the MHRA makes decisions on when a product is a medical device (borderline products), and which risk class should apply to a medical device.
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.
Advice for manufacturers of Class I medical devices for placing products on the UK market
What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Information about when you need to submit substantial amendments to a clinical trial including changes to the trial sponsor or legal representative, Investigational medicinal product certification and importation.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Past and current clinical trials into therapeutic and antiviral treatments for COVID-19, how to take part, and which treatments have proven to be effective.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
Information about the EU Regulations and their implementation in Northern Ireland
How investigators and sponsors should manage clinical trials during COVID-19
How to account for VAT on goods and services provided by registered health professionals, including doctors, dentists, nurses and pharmacists.
Find out about coronavirus (COVID-19) treatments available outside of hospital, including information on free prescriptions and lateral flow tests.
How to conform with the legal requirements for placing medical devices on the market.
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
The MHRA is ready to provide any assistance for clinical trials applications submitted for COVID-19
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