QA & RA News – July 2024

July 22, 2024
By Esther Kott

New standards and guidance documents from June and July 2024

Before the summer vacation, we wanted to bring to your attention the list below, so you can pin to your calendar the gap assessments and implementation plans needed once you’re back.

AI
• EU AI Act 2024/1689
• UK, USA, and Canada on AI – Guiding Principles
• FDA – Evaluation Methods for Artificial Intelligence (AI)-Enabled Medical Devices
• FDA – Transparency for Machine Learning-Enabled Medical Devices

IVDs
• FDA – Laboratory Developed Tests: Small Entity Compliance Guide
• MDCG 2020-16 Rev.3 Guidance on Classification Rules for In Vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
• Q&A on practical aspects related to the implementation of the extended transitional period provided for in the IVDR, as amended by Regulation (EU) 2024/1860

Specific Tests
• ISO 5910:2024 Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices
• IEC 80601-2-78:2019+AMD1:2024 Medical electrical equipment – Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation

Other
• MDCG 2021-5 Rev.1 Guidance on standardization for medical devices
• MDCG 2024-10 Clinical evaluation of orphan medical devices
• EU REACH Substances of Concern updated list

New Notified Bodies for EU MDR
• TUV SUD Denmark
• AFNOR
• MTIC InterCert Italy
• Kiwa Istanbul
• MS Services GmbH Austria

#CE, #FDA, #guidance, #IVDR, #MDR, #news, #standards

Esther Kott

Esther has over 5 years of experience in Regulatory Affairs for numerous medical device companies, representing all types of devices (from class I to class III combination devices). Her experience includes preparation of regulatory strategies; submissions and interactions with FDA (pre-submission, SIR, IDE, 510(k) notifications, etc.); preparation and submission of technical files and technical documentations to European Notified Bodies in compliance with the MDD, MDR, and IVDR; preparing and conducting summative HFE/usability studies; and assessment and documentation of Biological Evaluation, Clinical Evaluation, and Performance Evaluation. Esther holds a M.Sc. in Human Pathophysiology and a Ph.D. in Molecular Biology. She is certified in Biological Safety by NAMSA.

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