Description
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
LNE-GMED: https://assets.publishing.service.gov.uk/media/65b799f2a0ae1b000d52616e/LNE-GMED_Scope_Medical_Devices.pdf
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
EU
Notified Bodies
TUV SUD Denmark under MDR –Welcome to the Brother or Sister: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=150a0abbc0d4397086d648963fc940a321e02c11&group=NOTIFICATION&download=true
AFNOR 46th NB under MDR –Finally a second one for France:...
Published 05/02/24
A quality culture seem to be a nice to have. But after listening this podcast episode with Lesley Worthington, you will see that it is worth to build one. We will review the description of a quality culture and how to build it. But also if this is required by a regulation and how you can align it...
Published 04/23/24