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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..

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..

Draft requirements for post-market surveillance (PMS) of medical devices in the U.K. align closely with European regulations, but not entirely. Below, Emergo by UL continues our analysis of the proposed legislation. As noted in a previous Regulatory Update, a draft post-market surveillance statutory instrument (PMS SI) was laid in the U.K. Parliament (October 21) to introduce new PMS and vigilan..

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..

Background on post-market surveillance globallyPMS has been a pivotal topic. The European regulations (Medical Devices Regulation (2017/745, MDR) and In Vitro Diagnostic Devices Regulation (2017/746, IVDR)) officially defined the term PMS (Article 2(60)). In 2019, the U.S. FDA introduced the term Total Product Life Cycle (TPLC) as a "holistic” perspective with the FDA throughout the entire lifec..

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..

(출처: 한국의료기기협동조합) ▶ 일시: 2024년 10월 18일(금) 오전 10시~12시▶ 장소: 부산 BEXCO 218호▶ 주제: MDR PMS 및 Trend Reporting 사례 세미나▶ 업체: SZU KOREA▶ 신청기간: 2024년 09월 09일 (월) ~ 10월 11일(금)▶ 대상: 의료기기 업체 종사자 (선착순 50명)  [SZU KOREA] PMS 및 Trend Reporting 사례 세미나 모집 안내(10/18, 부산 키메스) – 한국의료기기협동조합 (medinet.or.kr) [SZU KOREA] PMS 및 Trend Reporting 사례 세미나 모집 안내(10/18, 부산 키메스) medinet.or.kr

Emergo by UL에서 EU MDR 관련 웨비나 예정 일자: 2023년 09월 26일 오전 9시~10시 (CDT, 한국시간 저녁 11시~12시) 주제: EU MDR PMS including PMCF and Vigilance EU MDR PMS Including PMCF and Vigilance | Emergo by UL EU MDR PMS Including PMCF and Vigilance In this complimentary webinar, our Emergo by UL subject matter expert will outline the latest insights about EU MDR PMS, including PMCF and vigilance. www.emergobyul.com