Draft-Content of Human Factors Information in Medical Device Marketing Submissions
人因工程应用于医疗器械的征求意见稿
链接：https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-human-factors-information-medical-device-marketing-submissions
二、欧盟
MDCG 2022-18 MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate
MDCG关于MDR法规第97条适用于MDD或AIMDD证书在MDR证书颁发之前过期的遗留设备的立场文件：如果MDR法规下的设备认证在指令证书到期之前尚未完成，并且设备不会对健康和安全造成不可接受的风险，则MDR法规第97条使CA能够要求相关制造商或其授权代表，在合理且明确规定的期限内结束违规行为。
链接：https://health.ec.europa.eu/system/files/2022-12/mdcg_2022-18_en.pdf MDCG 2022-19 Performance study application/notification documents under Regulation (EU) 2017/746
IVDR性能研究的要求以及申请表、GSPR、相关要求的文件格式
链接：https://health.ec.europa.eu/system/files/2022-12/mdcg_2022-19_en.pdf MDCG 2022-20 - Substantial modification of performance study under Regulation (EU) 2017/746
MDCG 2022-19是为了在欧洲医疗器械数据库EUAMED正式运行之前，对IVDR法规下如何进行性能研究的申请/通知作出指导，提供了一系列的性能研究申请/通知文件模板。MDCG 2022-20则是在此基础上又提供了一份“根据IVDR法规对性能研究进行实质性修改”的模板。
链接：https://health.ec.europa.eu/latest-updates/mdcg-2022-20-substantial-modification-performance-study-under-regulation-eu-2017746-december-2022-2022-12-14_en Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices-version 2
更新分类指南：确定边缘产品是否属于医疗器械的定义以及分类规则的适用是否属于该产品上市的成员国主管部门的权限范围
本次更新增加了边缘产品医疗计算器、针头计算器。
MDCG小组建议，该手册应与其他提供边界指导的指南文件一起阅读，如：
① MDCG 2022-5 Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices
② MDCG 2019-11 Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746.
链接：https://health.ec.europa.eu/latest-updates/manual-borderline-and-classification-under-regulations-eu-2017745-and-2017746-version2-december-2022-2022-12-15_en
三、英国
Guidance Register medical devices to place on the market
指南更新增加可以申请设备在线注册系统(DORS)上注册
链接：https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market Medical devices: guidance for manufacturers on vigilance
更新Incident reporting system
链接：https://www.gov.uk/government/collections/medical-devices-guidance-for-manufacturers-on-vigilance#full-publication-update-history
发表于 2022-12-25 14:19:05