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It has caused years and years of regulatory uncertainty: Which EU law regulates ethylene oxide (EtO) used for sterilization of medical devices? At least for medical device and IVD manufacturers, this should be clear by now, with the publication of “MDCG 2024-13 Regulatory status of ethylene oxide (EtO) intended for the sterilization of medical  devices”.  What the MDCG document regulating steril..

1. Introduction The regulatory status of ethylene oxide (EtO) for the sterilisation of single-use medical devices during the manufacturing process has been discussed in relation to the Review Programme under Regulation (EU) 528/2012 on biocidal products (BPR). Ethylene oxide (EtO) is used to sterilise a wide range of medical products, such as medical devices, in vitro diagnostic medical devices ..

While it was a whirlwind of less than 25 minutes for five lofty learning objectives on global regulatory strategy, we felt all the topics were seminal. A synopsis of one part of our presentation follows. The importance of a well-defined intended purpose and indications for useAs we continue to observe issues related to the intended purpose/use and indications for use, we emphasized the importanc..

Gamification is the planned use of game-like elements (such as virtual reality games, indoor games, interactive quizzes, progress tracking and rewarding with scores, badges and motivation feedback) to motivate individuals to engage in non-game activities. When considering the healthcare environment (for treatment, medication tracking and mental or physical wellbeing), including gamification can ..

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..

Background on NOM-240-SSA1-2024The regulator in Mexico, COFEPRIS, released on July 24, 2024, a new draft for the NOM for Medical Device Technovigilance, PROY-NOM-240-SSA1-2024. This update follows a trend of recent revisions over Mexican Standards (Emergo reported on PROY-NOM-137-SSA1-2024, Medical Device Labeling). The current version of NOM-240 was published in 2012, so an update was overdue t..

Emergo에서 아래와 같이 웨비나를 개최한다.​▶ 주제: Japan Regulatory Requirements - Medical Device Software▶ 일시: 2024년 08월 08일 CST 9시 (한국시간: 08월 08일 23시) As the global market for medical device software (SaMD) expands, navigating the regulatory landscape becomes increasingly critical for manufacturers. While many regions share similar regulatory approaches, Japan presents unique challenges and opportunities. Our u..

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..

Description The Commission and Member States have created MDR and IVDR tables. These tables aim to help manufacturers of medical devices and in vitro diagnostic medical devices, particularly small and medium-sized ones, understand the language requirements for the information and instructions that accompany a device in a specific country. The tables provide an overview of the language requiremen..

Procedures for the updates of the European Medical Device Nomenclature The European Medical Device Nomenclature (EMDN), as established by Article 26 of Regulation (EU) 2017/745 – Medical Device Regulation (MDR) and Article 23 of Regulation (EU) 2017/746 - In Vitro Diagnostic medical devices Regulation (IVDR), will be annually reviewed and updated based on the practical use of the EMDN and feedba..