Medical Device News february 2024 Regulatory Update



EU
• Transition to the IVDR and EUDAMED Roll Out -An extension? Never !!!!!: https://health.ec.europa.eu/system/files/2024-01/mdr_in-vitro-proposal.PDF
o Measures: https://ec.europa.eu/commission/presscorner/api/files/document/print/en/ip_24_346/IP_24_346_EN.pdf
o Question and Answers: https://ec.europa.eu/commission/presscorner/api/files/document/print/en/qanda_24_347/QANDA_24_347_EN.pdf
o Factsheet: https://health.ec.europa.eu/system/files/2024-01/mdr_in-vitro-factsheet_1.pdf
• MDCG 2024-1 Vigilance System for CE – Guidance and Template: https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1_en.pdf
o MDCG 2024-1-1 Device for Cardiac Ablation: https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-1_en.pdf
o MDCG 2024-1-2 Coronary Stents and associated delivery systems: https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-2_en.pdf
o MDCG 2024-1-3 Cardiac Implantable Electronic Devices (CIEDs): https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-3_en.pdf
o MDCG 2024-1-4 Breast Implants: https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-4_en.pdf
• Language requirements for Manufacturers (MDR & IVDR) – Check where English is not applicable:
o MDR: https://health.ec.europa.eu/system/files/2024-01/md_sector_lang-req-table-mdr.pdf
o IVDR: https://health.ec.europa.eu/system/files/2024-01/md_sector_lang-req-table-ivdr.pdf
eQMS
• your eQMS SmartEye – The best eQMS ever: https://eqms-smarteye.com

UK
• Future Regulation roadmap – We still have to wait: https://assets.publishing.service.gov.uk/media/659d3539aaae22001356dc3c/Roadmap_towards_the_future_regulatory_framework_for_medical_devices__Jan_24.pdf

Course
• Training EU MDR Green Belt – February and March 2024 : https://school.easymedicaldevice.com/gb/

Notified Bodies and Approved Bodies
• UK Approved bodies – They are 9 now: https://www.gov.uk/government/news/mhra-announces-two-new-uk-approved-bodies-to-certify-medical-devices
o LNE-GMED: https://assets.publishing.service.gov.uk/media/65b799f2a0ae1b000d52616e/LNE-GMED_Scope_Medical_Devices.pdf
o Scarlet NB UK: https://assets.publishing.service.gov.uk/media/65b79a11a0ae1b000d52616f/AB_Scarlet_Scope_Jan_2024.pdf

GDP video
• Good Documentation Practices – Check how to be sure to have good documents: https://www.youtube.com/watch?v=nkBpef5AstI

ROW
• USA
o US FDA Quality Management System Regulation – Alignment to ISO 13485: https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp/quality-management-system-regulation-final-rule-amending-quality-system-regulation-frequently-asked
o US FDA IVD Reclassification – Move from Class III to Class II: https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-announces-intent-initiate-reclassification-process-most-high-risk-ivds
o FDA Remote Regulatory Assessment (RRA) – Question and Answers: https://www.fda.gov/media/160173/download
o Estar 5.1 version -: IVD and non-IVD: https://www.fda.gov/medical-devices/how-study-and-market-your-device/estar-program
• Non-IVD: https://www.fda.gov/media/174458/download?attachment
• IVD: https://www.fda.gov/media/174459/download?attachment
• eStar 5.0 video with Rob Packard: https://www.youtube.com/watch?v=KDkKnRnBfgc
• Saudi Arabia
o Webinar: Artificial Intelligence and Software -:February 13th, 2024 at 10 AM Middle East time : https://www.sfda.gov.sa/en/workshop/93262

o Manufacturing Devices at Point of Care (PoC) – uidance on how to manufacture them: https://www.sfda.gov.sa/sites/default/files/2024-01/MDS%20%20G009E.pdf

Events
• Medtech Conf – RAPS Workshop – Feb 27th until March 1st: https://medtechconf.com/event/raps-events/

Title: Podcast Nostalgia – Relisten again and again
• Episode 267 – Warning! Apply to your Notified Body Now! with Pritam Mekala: https://podcast.easymedicaldevice.com/267-2/
• Episode 268 – You are not the Physical Manufacturer, can you be MDR certified: https://podcast.easymedicaldevice.com/268-2/
• Episode 269 – Why you should use Pre-Submission or Q-Sub with FDA: https://podcast.easymedicaldevice.com/269-2/

Whatsapp Community:
• Whatsapp community – Register even if it says no: https://chat.whatsapp.com/DvpnuGLihD98zGXsiYicQq

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