의료기기 이야기

Our webinar on the European Artificial Intelligence Act Regulation 2024/1689 emphasized the importance of risk categorization per the Medical Device Regulation (MDR, 2017/745) and In-Vitro Diagnostic Regulation (2017/746 IVDR) and the AI Act.The AI Act is now part of the new legislative frameworkThe AI Act is a new part of the new legislative framework and also applies to medical devices and IVD..

The first three months of 2025 have ended and our team has been ardently sharing regulatory news. No particular regulatory update was heralded as groundbreaking (other than news of an agreement between the Malaysia Medical Device Authority (MDA) and China NMPA to ease regulatory requirements for certain classes of devices). Progress from the International Medical Device Regulators Forum (IMDRF) ..

식품의약품안전처에서 의료기기 개발을 위한 우수 기계학습 (Machine Learning) 기준: 지도 원칙 민원인안내서를 제정하였다. ▶ 지도원칙 (Guiding Principles)1. 의료기기의 사용목적을 명확히 이해하고, 제품의 전체생명 주기 동안 다학제적 전문성을 활용한다.2. 전체생명주기에 걸쳐 우수한 소프트웨어 엔지니어링, 의료기기 설계 및 보안 원칙을 적용한다.3. 임상평가시, 의도된 환자 집단을 대표할 수 있는 데이터셋을 포함한다.4. 훈련 데이터와 시험 데이터는 독립적으로 설정한다.5. 사용목적에 부합하는 참조 표준을 선택한다.6. 사용 가능한 데이터와 의료기기의 사용목적에 맞게 모델을 선택하고 설계한다.7. 의료기기는 단순히 기기 단독의 성능이 아니라 의도된 사용 환경에서 인간-AI 협..

Emergo에서 아래와 같이 웨비나를 개최한다.​▶ 주제: EU AIA and its inter play with the EU MDR/IVDR▶ 일시: 2025년 03월 20일 CST 9시 (한국시간: 03월 20일 23시)  The European Union issued the Artificial Intelligence Act (AIA), published as Regulation (EU) 2024/1689 in the Official Journal of the European Union on July 12, 2024. The regulation places additional requirements on manufacturers of AI-enabled devices. Medical device ma..

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..

Clinical Decision Support (CDS) software are important tools in modern health care. While some CDS software has been excluded from the definition of a medical device by the 21st Century Cures Act (Cures Act), many software functions continue to meet the definition of a medical device and are the focus of the Food and Drug Administration’s (FDA) regulatory oversight. Because a wide variety of sof..

Today, the U.S. Food and Drug Administration expanded the indications of the Insulet SmartAdjust technology, an interoperable automated glycemic controller previously indicated for the management of type 1 diabetes in individuals two years and older, to also include management of type 2 diabetes in individuals 18 years and older. An interoperable automated glycemic controller is software that au..

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..

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 regulator in Mexico, COFEPRIS, released a 5.0 edition of the Supplement of Medical Devices of the Mexican Pharmacopoeia (hereafter: Pharmacopoeia), which inserted regulatory requirements for Software as a Medical Device (SaMD). Software was included officially in the definition of medical devices and rule 16 was added to Appendix II to classify software according to risk (Class I, II, or III..