UK Medical Device Regulator MHRA Announces Legislative Updates After the new legislation was laid out on 21 October 2024, a six-month transition period is provided, whereafter the amended regulations will come into force on June 16, 2025. This period allows stakeholders to adapt their processes and ensure compliance with the new requirements. In January 2025,…
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…
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…
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…
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…
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…
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…
Did that headline catch your attention? I thought so. Well is the MDR indeed dead or is it even alive? Since February 2023 there has been a serious drop in MDR activity, while many MDR gurus are still organising conferences discussing the regulations in a desperate attempt to keep the industry engaged, much of the…
MDCG Recommends Limits on Article 97 MDR Applications by EU Member States European regulators are recommending that European Union member states should limit the use of Article 97 Medical Devices Regulation (MDR) to particular circumstances involving legacy medical devices now that amendments extending MDR transition periods have been published. On July 1, 2023 the Medical…
MHRA Consultation on the future of regulating medical devices in the UK The UK Medicines and Healthcare products Regulatory Agency (MHRA) invites members of the public including patients, developers, manufacturers, suppliers, healthcare professionals and members of the wider public to provide their views regarding possible changes to the regulations for medical devices in the UK….