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[Emergo, UL] The new Great Britain vigilance report schema goes live

The new Great Britain (GB) vigilance report schema goes live on Monday, June 16 in alignment with the timing of the new post-market surveillance (PMS) regulations coming into force. The GB regulator has updated its online guidance hub with resources intended to assist with the implementation of the new schema. The Medicines and Healthcare products Regulatory Agency (MHRA) has long leveraged the ..

As previously reported, during a public consultation launched in November 2024, the UK medical device regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), proposed removing the revocation dates of four pieces of assimilated EU law so that they remain part of the statutory framework for medical devices in Great Britain (GB) until they are replaced with the updated UK law. U..

The Medicines & Healthcare products Regulatory Agency (MHRA) unveiled new guidance outlining the implementation of new manufacturer incident (MIR) and field safety corrective action (FSCA) report XML schema definitions (XSD) for Great Britain (GB) for the Manufacturer’s Online Reporting Environment (MORE) reporting system. This timing is aligned with the European Union (EU) MIR version 7.3.1 rel..

From August 29, 2024, to October 24, 2024, the Medicines & Healthcare products Regulatory Agency (MHRA) held a public consultation on its proposed amendments to the statutory fees. The consultation reflected fees for services related to medicines, medical devices and blood components for transfusion in the UK. The statutory fees for services are intended to recover the costs involved with the wo..

The International Medical Device Regulators Forum (IMDRF) released two key documents related to medical device software: Good machine learning practice for medical device development: Guiding principles (IMDRF/AIML WG/N88 FINAL:2025); and Characterization Considerations for Medical Device Software and Software-Specific Risk (IMDRF/SaMD WG/N81 FINAL:2025). These documents are aimed at improving g..

The Medicines and Healthcare products Regulatory Agency (MHRA) announced the release of a suite of post-market surveillance (PMS) guidance (January 15) in alignment with The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024. BackgroundAs Emergo by UL reported last month, the amendment introduces new and enhanced PMS requirements for manufacturer..

BackgroundThe draft PMS SI was initially shared on July 26, 2023, after the publication of the draft PMS SI on the World Trade Organization (WTO) website by the UK regulator MHRA. The revised final draft was shared again on October 22.The intent has always been to emphasize the importance of PMS, analogous to the European regulations (Medical Devices Regulation 2017/745 (MDR) and In Vitro Diagno..

BackgroundFollowing the 2021 government consultation on changes to the Medical Devices Regulations 2002 (MDR 2002), and now armed with even more information and experience, on Nov. 14, the U.K. medical device regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) announced the launch of a public consultation. The MHRA solicited members of the public, including patients, medica..

BackgroundAs noted in a previous Regulatory Update, the Medicines and Healthcare products Regulatory Agency (MHRA) has opened a public consultation on proposed changes to the medical device regulatory framework in GB. This includes the introduction of a new framework that would allow certain medical devices authorized by other countries to be placed on the GB market without needing a UKCA (U.K. ..

Background In Jan. 2024, the U.K. medical device regulator, the MHRA, shared a roadmap detailing how it planned to implement future medical device regulations. In September 2024, Dr. Robert Reid, Deputy Director, MHRA, Innovative Device, provided attendees at the RAPS Convergence with an update on that roadmap.On Nov. 1, Dr. Laura Squire, Chief Healthcare Quality and Access Officer, MHRA, publis..