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The European Commission’s Directorate-General for Health and Food Safety (DG SANTE) - through the European Health and Digital Executive Agency (HaDEA) - has commissioned a “Study supporting the monitoring of availability of medical devices on the EU market”. The study started in December 2022 and will be running for 36 months (December 2025). The study has been contracted to a consortium led by ..

This guidance document updates and clarifies the information regarding sterilization processes that we recommend sponsors include in 510(k)s for devices labeled as sterile. This guidance document also provides details about the pyrogenicity information that we recommend sponsors include in a 510(k) submission. For the current edition of the FDA-recognized standards referenced in this document, s..

The US Food and Drug Administration (FDA) has begun issuing export documents for medical devices in electronic format in order to help streamline processes and reduce time and effort for manufacturers seeking to sell their products in non-US markets. A letter to industry from FDA explains that the agency’s transition to electronic formats took effect January 2, 2024, and applies to documents suc..

Earlier this month I wrote about the importance of clinical trial transparency and the FDA’s oversight. Today, I’d like to catch up with you about another critical component of FDA’s oversight of clinical studies: our work to harmonize clinical research regulations and to facilitate the development of medical products to benefit public health. Modernizing Clinical Research Oversight Efficient, w..

▶ Introduction The Regulation (EU) 2017/745 on medical devices, hereafter referred to as the MDR (medical device regulation), provides a possibility to use clinical data related to an equivalent device in the clinical evaluation required for a device under conformity assessment. Whilst carrying out a clinical investigation is the most direct way to generate clinical data concerning the safety an..

▶ Introduction The Regulation (EU) 2017/745 on medical devices, hereafter referred to as the MDR, is applicable to the groups of products without an intended medical purpose that are listed in Annex XVI as from the date of application of the Commission Implementing Regulation (EU) 2022/2346, hereinafter referred to as the common specifications (CS). Products without an intended medical purpose t..

MDCG에서 발행된 문서를 기반으로 제조업체와 유럽대리인을 대상으로 설문조사를 진행하고 있다. 관심이 있으신 업체의 경우에는 확인 바랍니다. ▶ 기간: 2024년 01월 15일까지 (CET 23:59:59 까지) EUSurvey - Survey (europa.eu) Study supporting the monitoring of availability of medical devices on the EU market Surveys for MD and IVD manufacturers and aut ec.europa.eu

Emergo by UL 에서 위험관리 관련하여 웨비나를 진행한다. 유럽에서 개정된 EN ISO 14971:2019+A11:2021에 관한 내용도 포함될 예정이다. ▶ 일자: 2023년 12월 20일(금) 자정 (0시, CST 기준 오전 9시) ▶ 온라인으로 1시간동안 진행 예정 ▶ 링크 Integrated Risk Management Throughout Device Lifecycle | Emergo by UL Integrated Risk Management Throughout Device Lifecycle In this complimentary webinar, our Emergo by UL subject matter expert will outline the latest insights about int..

2023년 11월 15일자로 FDA에서 사이버보안과 관련된 내용을 추가 발표하였다 (Updated). [세부내용] November 15, 2023 – The FDA contracted with MITRE to develop the report, Next Steps Toward Managing Legacy Medical Device Cybersecurity RisksExternal Link Disclaimer. Legacy medical devices are those that cannot be reasonably protected against current cybersecurity threats, and these devices can pose significant risks to the health ..

This guidance document provides Food and Drug Administration’s (FDA’s or the Agency’s) recommendations on testing to assess the safety and compatibility of medical devices in the Magnetic Resonance (MR) Environment and the recommended format for Magnetic Resonance Imaging (MRI) Safety Information in medical device labeling. This guidance applies to all medical devices that might be used in the M..