EU
• Transition to the IVDR and EUDAMED Roll Out -An extension? Never !!!!!: health.ec.euro...
o Measures: ec.europa.eu/c...
o Question and Answers: ec.europa.eu/c...
o Factsheet: health.ec.euro...
• MDCG 2024-1 Vigilance System for CE - Guidance and Template: health.ec.euro...
o MDCG 2024-1-1 Device for Cardiac Ablation: health.ec.euro...
o MDCG 2024-1-2 Coronary Stents and associated delivery systems: health.ec.euro...
o MDCG 2024-1-3 Cardiac Implantable Electronic Devices (CIEDs): health.ec.euro...
o MDCG 2024-1-4 Breast Implants: health.ec.euro...
• Language requirements for Manufacturers (MDR & IVDR) - Check where English is not applicable:
o MDR: health.ec.euro...
o IVDR: health.ec.euro...
eQMS
• your eQMS SmartEye - The best eQMS ever: eqms-smarteye.com
UK
• Future Regulation roadmap - We still have to wait: assets.publish...
Course
• Training EU MDR Green Belt - February and March 2024 : school.easymed...
Notified Bodies and Approved Bodies
• UK Approved bodies - They are 9 now: www.gov.uk/gov...
o LNE-GMED: assets.publish...
o Scarlet NB UK: assets.publish...
GDP video
• Good Documentation Practices - Check how to be sure to have good documents: • Learn the Good Documen...
ROW
• USA
o US FDA Quality Management System Regulation - Alignment to ISO 13485: www.fda.gov/me...
o US FDA IVD Reclassification - Move from Class III to Class II: www.fda.gov/me...
o FDA Remote Regulatory Assessment (RRA) - Question and Answers: www.fda.gov/me...
o Estar 5.1 version -: IVD and non-IVD: www.fda.gov/me...
• Non-IVD: www.fda.gov/me...
• IVD: www.fda.gov/me...
• eStar 5.0 video with Rob Packard: • What’s new in FDA eSTA...
• Saudi Arabia
o Webinar: Artificial Intelligence and Software -:February 13th, 2024 at 10 AM Middle East time : www.sfda.gov.s...
•
o Manufacturing Devices at Point of Care (PoC) - uidance on how to manufacture them: www.sfda.gov.s...
Events
• Medtech Conf - RAPS Workshop - Feb 27th until March 1st: medtechconf.co...
Title: Podcast Nostalgia - Relisten again and again
• Episode 267 - Warning! Apply to your Notified Body Now! with Pritam Mekala: podcast.easyme...
• Episode 268 - You are not the Physical Manufacturer, can you be MDR certified: podcast.easyme...
• Episode 269 - Why you should use Pre-Submission or Q-Sub with FDA: podcast.easyme...
Whatsapp Community:
• Whatsapp community - Register even if it says no: chat.whatsapp....
Негізгі бет Medical Device News february 2024 Regulatory Update
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