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[Emergo, UL] Article 16(4) MDR & IVDR Certification: What Medical Device Manufacturers Need to Know

As Notified Bodies (NBs) in the European Union (EU) begin to roll out Article 16(4)  of the European Medical Devices Regulation 2017/745 (MDR) and the European In-vitro Diagnostic Medical Device Regulation 2017/746 (IVDR)  certification schemes, we at Emergo by UL share our insights on the requirements set out in Article 16 and their applicability to importers, distributors and other natural or ..

Addressing potential usability issues early in the human factors engineering (HFE) process can save your team time and money over the course of development while providing evidence of a robust human factors process to regulatory agencies. Cognitive walkthroughs are a powerful method to identify potential usability issues in early development stages when initial decisions about design directions ..

Importance of reviewing warning lettersBy reviewing relevant U.S. Food and Drug Administration (FDA) warning letters, manufacturers can better understand areas of frequent concern related to quality management systems (QMS) and regulatory affairs. This can allow companies to focus on areas of highest risk as they continually assess and improve their internal procedures and processes. It also hel..

Legislative background on shortagesOn March 2, 2022, amendments to the legislation in Canada, Medical Devices Regulations (SOR/98-282, Part 1, Sections 62.21 to 62.26) came into force. These provisions discuss the notification of shortages to the regulator Health Canada. If an explicit device is delineated on the “List of Medical Devices- Notification of Shortages” and the manufacturer or import..

The technical document Terminologies for Categorized Adverse Event Reporting (AER): Terms, Terminology and Codes has been updated by The International Medical Device Regulators Forum (IMDRF) Adverse Event Terminology working group (AET WG). The current update consists of 36 newly added terms, changes to 56 existing terms and the retirement of eight terms. Release notes that provide a high-level ..

From August 29, 2024, to October 24, 2024, the Medicines & Healthcare products Regulatory Agency (MHRA) held a public consultation on its proposed amendments to the statutory fees. The consultation reflected fees for services related to medicines, medical devices and blood components for transfusion in the UK. The statutory fees for services are intended to recover the costs involved with the wo..

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..

Background on eSTARThe electronic submission template and resource (eSTAR) template can be used to submit US FDA Premarket Notifications (510(k)s), De Novos, and Traditional Premarket Applications (PMAs). eSTAR was compulsory for 510(k) submissions starting in October 2023. eSTAR will be required for De Novos starting in October 2025.eSTAR version 5.5eSTAR Version 5.5 was released (February 12)...

The European Commission (EC) opened a four-week consultation on draft legislation allowing electronic Instructions for Use (eIFU) for medical devices used by professional users. Here’s what medical device manufacturers need to know about the proposed legislation.Implementing Regulation 2021/2226 was intended to generally continue to advance Regulation 207/2012 on eIFU as devices (Article 3) that..

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..