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Guidance on registration of medical devices that are reusable or upclassified Class I devices, and/or reliant on expired or expiring CE certificates.
A 5-year deal setting out how community pharmacy will support delivery of the NHS Long Term Plan.
Guidance on the importance of applying human factors to medical devices, so they are designed and optimised to minimise patient and user safety risks.
Information on the implementation of labelling and packaging requirements for medicinal products for human use under the Windsor Framework.
Examples of what manufacturers must report to the MHRA under the medical device vigilance system when incidents involving their devices occur in the UK.
How manufacturers can apply for approval to supply a non-compliant medical device on humanitarian grounds.
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
Information and recommendations for approved bodies on the presentation and review of a periodic safety update report (PSUR).
Documentation to support changes made to reporting Manufacturer Incident Reports (MIRs) and Field Safety Corrective Action Reports (FSCAs) to the MHRA following implementation of the Medical Devices (Post-market Surveillance…
E-learning modules for healthcare professionals on minimising the risks of using medicines and information on how to access medical device modules.
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
Information for clinicians and patients.
The MHRA accepts an Active Substance Master File and/or a Certificate of Suitability in both new national initial Marketing Authorisation Applications (MAA) and in Marketing Authorisation Variation (MAV) applications.
Phase 2 of the Airlock will include seven additional technologies spanning AI-powered clinical note taking, advanced cancer diagnostics, eye disease detection tools, and obesity treatment support systems.
Points to consider when using real-world data in clinical studies
Sets out the payment due from members of the voluntary scheme for branded medicines pricing, access and growth in 2026.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
Also covering requests for waivers or deferrals and concerning the operation of the compliance check.
A step-by-step guide on using the MORE Platform for Registrations for Submissions of device related incidents.
The MHRA have implemented a dual strategy for a risk-adapted approach to clinical trials in the UK.
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