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Departments, agencies and public bodies
News stories, speeches, letters and notices
Detailed guidance, regulations and rules
Reports, analysis and official statistics
Consultations and strategy
Data, Freedom of Information releases and corporate reports
How we regulate in vitro diagnostic medical devices (IVDs) that are placed on the UK market.
How to change the ownership from one marketing authorisation (MA) holder to another.
A step-by-step guide on using the MORE Platform for Registrations for Submissions of device related incidents.
Guidance on the process for ending a clinical trial.
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
Guidance on the deadlines for initial and response submissions.
Helping manufacturers define the characteristics of their devices and determine the appropriate regulatory qualification and classification.
What you need to do before your product can be placed on the Great Britain market with a UKCA mark.
Resources for World Antimicrobial Resistance Awareness Week (WAAW) and European Antibiotic Awareness Day (EAAD) for healthcare professionals in England.
Information about the MHRA graduate scheme which is currently closed for applications.
Anyone in Northern Ireland selling medicines to the public via a website must still comply with the requirement to apply the EU common logo.
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines
There are changes to the legislation on reference medicinal products (RMPs) used to support abridged marketing authorisation applications.
Clinical trial applications that need expert advice from a specialist group or committee.
The MHRA’s AI Airlock pilot phase ran between April 2024 and March 2025. This report does not constitute formal MHRA guidance.
Details of the organisations that are currently approved to undertake conformity assessments on medical devices.
This guidance summarises our approach to pharmacovigilance
How to join the phase I accreditation scheme.
Key insights of three simulation workshops from the AI Airlock pilot testing programme. Please note that these documents are not formal guidance.
Information and recommendations for approved bodies on the presentation and review of a periodic safety update report (PSUR).
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