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How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
Information about how approved bodies help regulate medical devices and how to apply for approval.
Information about Clinical Trials Regulations outlining expanded enforcement provisions, offences, and compliance requirements for sponsors and investigators.
How we engage and involve patients and the public in our regulatory decision-making.
What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
A proposed format to help prepare responses to good distribution practice (GDP)/good manufacturing practice (GMP) post inspection letters.
How manufacturers can apply for approval to supply a non-compliant medical device on humanitarian grounds.
Information and advice on submitting a nutritional product to the Advisory Committee for Borderline Substances (ACBS).
Guidance for marketing authorisation holders on drafting direct healthcare professional communications (DHPCs)
What 'single-use' means and what symbol is used by manufacturers to show this.
Advice for manufacturers of DMHTs that qualify as software as a medical device (SaMD) on understanding new post marketing surveillance rules and examples of how they apply.
Guiding principles for the use of predetermined change control plans (PCCPs) for managing rapid product changes in medical devices.
Guidance on the importance of applying human factors to medical devices, so they are designed and optimised to minimise patient and user safety risks.
Meningitis is a serious infection that can develop quickly and affect people of all ages
Advice and guidance on the management and use of point-of-care testing (POCT) in vitro diagnostic (IVD) devices.
Sets out deliverables and timelines to support the development of safe In Vitro Diagnostic (IVD) medical devices.
Guidelines to provide developers of biosimilar products with a clear outline of the requirements in Great Britain.
How the MHRA decides whether to approve a clinical investigation for medical devices.
A practical guide to using medical devices in a range of healthcare settings.
Labelling requirements for e-liquids.
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