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Emergo에서 아래와 같이 웨비나를 개최한다.​▶ 주제: Determining when to utilize the pre-submissions Q-submission (Pre-Sub) Process▶ 일시: 2025년 03월 12일 CST 9시 (한국시간: 03월 12일 23시)  China’s medical product regulator, the National Medical Product Administration (NMPA), finalized their Human Factors (HF) guidance “Guidelines for the review of medical device usability engineering registration” in March 2024. The guidance..

Medical device manufacturers doing business in the European Union (EU) will want to review the most recent version of the MDCG 2019-6 Questions and Answers (Q&A) document, which represents the most significant update to date, with five updated Q&As, two replacement Q&As, and one new Q&A. Of particular interest in this update, Question I.6 (Q I.6) concerns whether notified bodies would be able to..

2025 Commission Work Program The European Commission (EC) shared its priorities for 2025 (February 11, 2025). A press release accompanied the announcement, fact sheet and formal communication (COM(2025) 45 final), as well as the corresponding ANNEXES 1 to 5.The primary message: “Moving forward together: A Bolder, Simpler, Faster Union”.The communication describes the actions the EC intends to pr..

The United States Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) recently released its 2024 Annual Report (link currently broken, but we will post once available from CDRH) highlighting some of its achievements over the past year. This is a summary of the main topics.The US FDA CDRH in 2024The CDRH is responsible for regulating medical devices in the U.S. It..

Understanding pen-injector use errors and their implicationsThe proliferation of pen-injectors used by laypeople for self-administration of medication in their homes has caused regulators, such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA), to task manufacturers with providing sufficient evidence to demonstrate that all users, especially laypeopl..

Why pilot tests are essential for usability studiesDeveloping a methodology for usability studies can involve uncertainty and introduce questions such as “How long should the test session last?,” “How can I improve my setup?” or “Is this prompt clear enough?” Running pilot test sessions prior to formal testing can help you find answers to these questions and increase the data quality of your upc..

What is the European Medical Device Nomenclature?Recently we updated you on Regulation (EU) 2024/1860 and how this amendment introduces a new approach on mandatory use of certain EUDAMED modules. Currently, 3 modules are live and those modules are expected to become mandatory in the upcoming year. One of the modules is the UDI/Device module. This module requires manufacturers to register their d..

Why a known problems analysis is crucial for NMPA complianceA known problems analysis (KPA) is a human factors engineering (HFE) activity that aims to identify use issues and user interface flaws with devices currently on the market. Regulators require medical device manufacturers to conduct a KPA to investigate use problems associated with devices that are similar to a device under development ..

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..

This month, the U.S. Food and Drug Administration (FDA), finalized guidance requiring manufacturers to notify them of discontinuations or meaningful interruptions in manufacturing for many devices during or in advance of a public health emergency (PHE). This relatively new authority was established through the 2020 CARES Act and amended by the 2023 Omnibus Consolidated Appropriations Act, alteri..