December 2024 – Medical Devices Regulatory Insights
UK Medical Device Regulator MHRA Announces Legislative Updates The Post-market Surveillance (PMS) Statutory Instrument (SI) laid in Parliament on 21 October 2024 was the first major update to the framework of medical device regulations in Great Britain. Since January 2021 all medical devices have been required to be registered with the MHRA before they can…
September 2024 – Medical Devices Regulatory Insights
UK Medical Device Regulator MHRA Announces Legislative Updates The MHRA, the UK medical device regulator, gave a progress report on the agency’s work toward completing its roadmap of medical device legislation. On September 18, Robert Reid, Ph.D. Deputy Director, Innovative Devices at the MHRA, updated the RAPS audience on the current status of the UK…
July 2024 – Medical Devices Regulatory Insights
MHRA announces a proposed framework for international recognition of medical devices The Medicines and Healthcare products Regulatory Agency (MHRA) on 21 May 2024 published a statement of policy intent for international recognition of medical devices. The MHRA’s statement of policy intent describes how the UK Government intends to recognise regulatory approvals from Australia, Canada, the…
April 2024 – Medical Devices Regulatory Insights
Update from MHRA on UK MedTech Regulatory Reform The UK medical device regulator, the Medicines and Healthcare products Regulatory Authority (MHRA), presented a webinar (March 5) on the upcoming changes to the medical devices legislation for Great Britain (GB). The webinar provided an update on the draft policy on scope, classification and essential requirements for…
January 2024 – Medical Devices Regulatory Insights
MHRA sets out a new Roadmap to protect patient safety and allow access to medical technology including AI and diagnostics. Medicines and Healthcare Products Regulatory Agency (MHRA) has published a roadmap for developing new and robust regulations for medical devices in the UK and are designed to provide greater international harmonisation. Access roadmap for 2024/2025…
October 2023 – Medical Devices Regulatory Insights
Medtech Could Help Address EU’s Worsening Healthcare Workforce Crisis Belgium, when it takes over the presidency of the Council of the European Union in January 2024, intends to make the EU’s worsening healthcare workforce crisis “one of the main priorities at the EU level for the upcoming years and the next Commission.”. That is according…