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Advice and guidance on the management and use of point-of-care testing (POCT) in vitro diagnostic (IVD) devices.
Information on taking, submitting and processing samples which potentially contain monkeypox virus.
How the MHRA makes decisions on what is a medicinal product (borderline products).
Information about the EU Regulations and their implementation in Northern Ireland
Information and guidance on a range of medical devices for users and patients.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
Patients benefit from tests and scans at 155 centres now open in England, with AI scanners on the way to further bolster diagnostic offer.
Community diagnostic centre (CDC) sites have already delivered over 7 million tests, checks and scans to patients across England.
Advice for manufacturers of Class I medical devices for placing products on the UK market
How to conform with the legal requirements for placing medical devices on the market.
How to begin with evaluating a digital health product, including when to evaluate, budgeting and getting support.
The mycology reference laboratory (MRL) provides a comprehensive laboratory service for the diagnosis and management of fungal infections.
How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
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