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How to comply with the regulations when using a medical device differently to the manufacturer's instructions.
A taxonomy of different incident types, modalities and outcomes in clinical imaging, MRI and nuclear medicine.
Supplementary information on the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
Information for manufacturers on the regulations that apply to prosthetic, orthotic and ophthalmic devices.
How investigators and sponsors should manage clinical trials during COVID-19
How we engage and involve patients and the public in our regulatory decision-making.
Information for patients, healthcare professionals and the wider public to help better understand the importance of AAIs as a potential life-saving medicine.
Guidance for manufacturers on reporting adverse incidents involving breast implants under the vigilance system.
Types of ingredients permitted in nicotine-containing liquids in electronic cigarettes and refill containers.
What 'single-use' means and what symbol is used by manufacturers to show this.
Actions QPs, RPis and RPs need to take following agreement of the Windsor Framework
Information for people who wish to apply to release a vaccine or a blood product to market in the UK.
MHRA’s mechanism for evaluating the justifications supplied by applicant organisations who plan to utilise decentralised manufacture.
Guidance for holders of marketing authorisations (MAs) approved in Northern Ireland (NI) who want to bring a product to market in Great Britain (GB).
Checklists providing a practical guide to using medical devices in a range of healthcare settings.
Guidance for medical device manufacturers on when to use electronic instructions and how to comply with the regulations.
How to apply to have nutritional or dermatological products reviewed by the Advisory Committee on Borderline Substances (ACBS).
The Defence and Security Accelerator (DASA) is running a Market Exploration to explore research and technology development of relevance to the modelling of traumatic wounds and the monitoring of their progression.
The EU has published guidance on exemptions for medical devices manufactured and used within EU health institutions, which applies to Northern Ireland-based health institutions, replacing interim guidance from the MHRA.
Guidance on registration of certain in vitro diagnostic devices reliant on expired or expiring CE certificates or declarations of conformity.
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