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The U.S. Food and Drug Administration (FDA) issued a new draft human factors engineering (HFE) guidance document, Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products, on July 8, 2024. The guidance informs manufacturers of drug- and biologic-led combination products about the purpose and content of a use-related risk analysis (URRA) and how a ..

Background on battery regulationIn Europe, the Battery Regulation 2023/1542 was released in July 2023 with various deadlines to replace the Battery Directive 2006/66/EC. One fundamental aspect is that the legislation was promulgated as a Regulation and aligned to the New Legislative Framework (NLF). Recital 53 explained that this would help ensure “batteries are stored, used and discarded in a m..

Emergo by UL has been reporting on the landmark legislation that is the Artificial Intelligence Act (AIA). As the AIA was given the green light by EU institutions and the finish line is in sight, it seems fitting to conclude our regulatory series with a brief recap, as well as a focus on the high-risk AI systems on which the regulation is mainly concerned.RecapThe EU AIA  introduces a risk-based..

「유럽 MDR 인증획득 기업 지원」사업의 일환으로 발간한 유럽 의료기기 월간동향소식지 2024년 6월호를 게재합니다.  ▶ 세부내용수술용 메시에 대한 부작용 사례 보고서 통합을 위한 MDCG의 목표EU 인공지능법 (AIA)  유럽의료기기 월간동향 소식지_2024년 6월 – 한국의료기기협동조합 (medinet.or.kr) 유럽의료기기 월간동향 소식지_2024년 6월「유럽 MDR 인증획득 기업 지원」사업의 일환으로 발간한 유럽 의료기기 월간동향소식지 2024년 6월호를 게재합니다. 업무에 참고하시기 바랍니다.    medinet.or.kr

Global harmonization continues to excite us all. And, global harmonization of medical device registration submissions is one way to advance the objectives of the International Medical Device Regulators Forum (IMDRF) and regulatory reliance. These documents are a must-read for any serious regulatory professional. Here we elaborate on our regulatory update featured in April 2023.  Background on IM..

This is the third in our series of regulatory updates on the EU Artificial Intelligence Act (AIA). Since more than one month has passed since the law’s approval, we are providing this article ahead of the AIA’s publication in the Official Journal of European Union (OJEU). BackgroundOn May 21 2024, the EU AIA was approved and given the final green light by the EU Council. The AIA establishes requ..

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) ..

Regardless of a medical product’s complexity, manufacturers have many considerations when it comes to applying human factors during development. Applying human factors to a whole system of medical products versus a singular product might seem even more intimidating. Furthermore, additional complexities might emerge when applying human factors to a system of products where all products or compone..

Even three weeks after the 2024 Hospitalar conference in Brazil, it is still worth highlighting some important points raised by Marcella de Abreu, GEVIT/ANVISA Manager, during her presentation covering the RDC 830/2023 legislation for in vitro diagnostic devices. This also serves as a reminder that RDC 830/2023 now applies to IVDs and products within the scope of IVDs in Brazil.Background on RDC..

The New Zealand (NZ) Associate Minister of Health announced the intent to repeal the Therapeutic Products Act 2023 (TPA), which otherwise would come into force this year, with most provisions taking effect on September 1, 2026. On May 23, the Associate Minister also released a lightly redacted Cabinet paper and decision meeting minutes outlining the rationale behind the Ministry decision. Develo..