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How to get fast-track approval of medical devices during COVID-19.
Information about the EU Regulations and their implementation in Northern Ireland
Medicines and Healthcare products Regulatory Agency (MHRA) guidance on using medical devices safely.
List of Field Safety Notices from 22 to 26 April 2024.
How to conform with the legal requirements for placing medical devices on the market.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Information on how to request assistance from NSDR.
Check the legal requirements you need to meet before you can place a medical device on the market and see how MHRA monitors compliance.
This document contains the following information: Medical Supplies Agency annual report and financial accounts 2004 to 2005.
The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK. MHRA is an executive agency, sponsored by the Department of Health and Social Care .
Advice on writing clear notices and maximising replies to your FSNs.
How the MHRA makes decisions on what is a medicinal product (borderline products).
How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland
Advice for manufacturers of Class I medical devices for placing products on the UK market
Guide for overseas investors on how to access NHS procurement channels.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
Information for healthcare professionals on how pulse oximeters are regulated, home use and issues to look out for when using the devices
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