Medical Device News february 2024 Regulatory Update
Medical Device made Easy Podcast
English - February 07, 2024 09:15 - 40.1 MB - ★★★★★ - 17 ratingsCareers Business Education Courses medical device regulation medtech industry regulatory affairs iso mdr 2017/745 Homepage Download Apple Podcasts Google Podcasts Overcast Castro Pocket Casts RSS feed
This month we'll talk about the updates in EU and the rest of the world. The IVDR extension, the MDCG guidances, the language requirements, the trainings, events, podcast... ALL ALL ALL. Check that now.
The post Medical Device News february 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
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
The post Medical Device News february 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir