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How to apply for an exceptional use authorisation to place medical devices on the UK market.
The MMRV vaccine will become part of the routine childhood immunisation schedule in the UK from 1 January 2026.
Guidance on defining intended purpose for Software as a Medical Device (SaMD), to help SaMD manufacturers in meeting their statutory obligations.
E-learning modules for healthcare professionals on minimising the risks of using medicines and information on how to access medical device modules.
Guidance on conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice.
A step-by-step guide on using the MORE Platform for Submissions of device related incidents.
How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
Information on clinical trial record retention and archiving requirements including requirements for ownership, data integrity, and transitional provisions.
Clinical trial applications that need expert advice from a specialist group or committee.
UK guideline on GMP for decentralised manufacturing, ensuring compliance with EU GMP principles for safe, quality medicinal products.
Information for clinicians and patients.
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
Reforms to ensure that medical device regulation is fit for purpose for software products, including artificial intelligence (AI).
Examples of what manufacturers must report to the MHRA under the medical device vigilance system when incidents involving their devices occur in the UK.
Information and recommendations for approved bodies on the presentation and review of a periodic safety update report (PSUR).
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by marketing authorisation holders (MAHs).
Information on the implementation of labelling and packaging requirements for medicinal products for human use under the Windsor Framework.
Recommendations for prescribing methadone and buprenorphine to people in treatment for opioid dependence in England.
A step-by-step guide on using the MORE Platform for Registrations for Submissions of device related incidents.
Since, April 2024, the MHRA has been using Lorenz DocuBridge for eCTD management in product licence submissions. This change is part of the modernisation of the MHRA’s Legacy Systems and is one of the initial tools launched …
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