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

Measures: https://ec.europa.eu/commission/presscorner/api/files/document/print/en/ip_24_346/IP_24_346_EN.pdf

Question and Answers: https://ec.europa.eu/commission/presscorner/api/files/document/print/en/qanda_24_347/QANDA_24_347_EN.pdf

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

MDCG 2024-1-1 Device for Cardiac Ablation: https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-1_en.pdf

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

MDCG 2024-1-3 Cardiac Implantable Electronic Devices (CIEDs): https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-3_en.pdf

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:

MDR: https://health.ec.europa.eu/system/files/2024-01/md_sector_lang-req-table-mdr.pdf

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

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

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

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

FDA Remote Regulatory Assessment (RRA) - Question and Answers: https://www.fda.gov/media/160173/download

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

Webinar: Artificial Intelligence and Software -:February 13th, 2024 at 10 AM Middle East time : https://www.sfda.gov.sa/en/workshop/93262

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/

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