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Data, Freedom of Information releases and corporate reports
Reforms to ensure that medical device regulation is fit for purpose for software products, including artificial intelligence (AI).
Helping interpret the Human Medicines (Amendment) Modular Manufacture and Point of Care regulations 2025.
Guidance on registration of medical devices that are reusable or upclassified Class I devices, and/or reliant on expired or expiring CE certificates.
Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission.
Anyone in Northern Ireland selling medicines to the public via a website must still comply with the requirement to apply the EU common logo.
An overview of the five technologies selected for the AI Airlock pilot.
Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
Information on the implementation of labelling and packaging requirements for medicinal products for human use under the Windsor Framework.
Guidance on how to report suspected adverse incidents and safety concerns with diabetes management equipment to the Yellow Card scheme.
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.
A list of individual human medicinal products under the new arrangements coming into effect on 1 January 2025 following agreement of the Windsor Framework.
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.
Information relating to parallel imports and the implementation of the Windsor Framework.
Guidance on defining intended purpose for Software as a Medical Device (SaMD), to help SaMD manufacturers in meeting their statutory obligations.
Information about how approved bodies help regulate medical devices and how to apply for approval.
Information for patients, healthcare professionals and developers of new medicines
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by marketing authorisation holders (MAHs).
Guidance on conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice.
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