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Links to EU guidance, as it stood immediately before end of transition period.
How manufacturers can apply for approval to supply a non-compliant medical device on humanitarian grounds.
This guide has been provided to reduce the burden when preparing responses to Post Inspection Letters.
Every year MHRA receives requests for its staff to speak at conferences and other events across the world.
Information for clinicians and patients.
A 5-year deal setting out how community pharmacy will support delivery of the NHS Long Term Plan.
The different types of tests and testing kits for COVID-19, and the specifications for manufacturers.
This publication supports local authority health and wellbeing boards to develop and update pharmaceutical needs assessments (PNAs).
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.
The UK Good Laboratory Practice Monitoring Authority (UK GLPMA) recognises that there are potential challenges COVID-19 will present to members of the GLP monitoring programme.
Details of how Marketing Authorisation Holders can provide information on planned or potential future submissions, to the MHRA.
Guidance on the steps manufacturers and suppliers can take to ease supply shortages.
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.
Information relating to parallel imports and the implementation of the Windsor Framework.
Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.
Guidance for manufacturers of cardiac implantable electronic devices and their leads. It outlines specific scenarios that should be considered when determining if an incident is reportable.
How and when to register updated packaging and information leaflets when new national marketing authorisations have been issued
Key insights of three simulation workshops from the AI Airlock pilot testing programme. Please note that these documents are not formal guidance.
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.
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