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How manufacturers in Northern Ireland should undertake a clinical investigation for medical devices to ensure they comply with EU medical device regulations.
How to renew marketing authorisations for products granted through different routes and at different times.
How to notify the MHRA that you are going to undertake a clinical investigation of a medical device.
Information for healthcare professionals on how pulse oximeters are regulated, home use and issues to look out for when using the devices
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
How to change the ownership from one marketing authorisation (MA) holder to another.
UK guideline on GMP for decentralised manufacturing, ensuring compliance with EU GMP principles for safe, quality medicinal products.
How to comply with the regulatory requirements for manufacturing custom-made medical devices.
A step-by-step guide on using the MORE Platform for Registrations for Submissions of device related incidents.
Information about the MHRA's duties and how you can report a non-compliant medical device.
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
This guidance summarises our approach to pharmacovigilance
Information on sourcing medicines that can be supplied by wholesale distributor authorisation (WDA) holders based in the UK.
Details of the organisations that are currently approved to undertake conformity assessments on medical devices.
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.
There are changes to the legislation on reference medicinal products (RMPs) used to support abridged marketing authorisation applications.
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 …
Sets out the government's current position on the use of DEXA scans in the UK.
Sets out deliverables and timelines to support the development of safe In Vitro Diagnostic (IVD) medical devices.
Safety leaflet on epilepsy medicines and pregnancy to help patients and their families understanding the risks.
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