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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..

BackgroundFollowing the publication of the draft PMS SI on the World Trade Organization (WTO) website on July 26, 2023, the Medicines and Healthcare products Regulatory Agency (MHRA) has, after considering stakeholder responses to that draft, published the “final” draft PMS SI. This instrument introduces new PMS requirements for medical devices that improve patient safety by establishing stricte..

On September 18, Robert Reid, Ph.D. Deputy Director, Innovative Devices at the Medicines and Healthcare products Regulatory Agency (MHRA), updated the RAPS audience on the current status of the UK legislation. To our knowledge, this is one of the most recent updates from the MHRA. The first half of 2024In January 2024, the MHRA shared a roadmap for 2024-2025. The roadmap proposed regulatory refo..

The US Food and Drug Administration (FDA), Health Canada and UK MHRA (June 13) built on their 2021 guiding principles for good machine learning practice for medical device development by further identifying guiding principles for transparency for machine learning-enabled medical devices (MLMDs). As the healthcare sector continues to experience rapid proliferation of artificial intelligence (AI) ..

This week the UK medical device regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) announced the launch of a four-week public consultation seeking the views of various stakeholders to improve safety measures for high-risk IVDs by including Common Specification (CS) requirements in the UK legislation (Medical Devices Regulations 2002 (MDR 2002)). In addition, they also seek..