Medical Device News february 2024 Regulatory Update
Вставка
- Опубліковано 6 лют 2024
- EU
• Transition to the IVDR and EUDAMED Roll Out -An extension? Never !!!!!: health.ec.europa.eu/system/fi...
o Measures: ec.europa.eu/commission/press...
o Question and Answers: ec.europa.eu/commission/press...
o Factsheet: health.ec.europa.eu/system/fi...
• MDCG 2024-1 Vigilance System for CE - Guidance and Template: health.ec.europa.eu/system/fi...
o MDCG 2024-1-1 Device for Cardiac Ablation: health.ec.europa.eu/system/fi...
o MDCG 2024-1-2 Coronary Stents and associated delivery systems: health.ec.europa.eu/system/fi...
o MDCG 2024-1-3 Cardiac Implantable Electronic Devices (CIEDs): health.ec.europa.eu/system/fi...
o MDCG 2024-1-4 Breast Implants: health.ec.europa.eu/system/fi...
• Language requirements for Manufacturers (MDR & IVDR) - Check where English is not applicable:
o MDR: health.ec.europa.eu/system/fi...
o IVDR: health.ec.europa.eu/system/fi...
eQMS
• your eQMS SmartEye - The best eQMS ever: eqms-smarteye.com
UK
• Future Regulation roadmap - We still have to wait: assets.publishing.service.gov...
Course
• Training EU MDR Green Belt - February and March 2024 : school.easymedicaldevice.com/gb/
Notified Bodies and Approved Bodies
• UK Approved bodies - They are 9 now: www.gov.uk/government/news/mh...
o LNE-GMED: assets.publishing.service.gov...
o Scarlet NB UK: assets.publishing.service.gov...
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/medical-devices/q...
o US FDA IVD Reclassification - Move from Class III to Class II: www.fda.gov/medical-devices/m...
o FDA Remote Regulatory Assessment (RRA) - Question and Answers: www.fda.gov/media/160173/down...
o Estar 5.1 version -: IVD and non-IVD: www.fda.gov/medical-devices/h...
• Non-IVD: www.fda.gov/media/174458/down...
• IVD: www.fda.gov/media/174459/down...
• 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.sa/en/workshop/9...
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o Manufacturing Devices at Point of Care (PoC) - uidance on how to manufacture them: www.sfda.gov.sa/sites/default...
Events
• Medtech Conf - RAPS Workshop - Feb 27th until March 1st: medtechconf.com/event/raps-ev...
Title: Podcast Nostalgia - Relisten again and again
• Episode 267 - Warning! Apply to your Notified Body Now! with Pritam Mekala: podcast.easymedicaldevice.com...
• Episode 268 - You are not the Physical Manufacturer, can you be MDR certified: podcast.easymedicaldevice.com...
• Episode 269 - Why you should use Pre-Submission or Q-Sub with FDA: podcast.easymedicaldevice.com...
Whatsapp Community:
• Whatsapp community - Register even if it says no: chat.whatsapp.com/DvpnuGLihD9...
Hi! I had a quick question about MDCG-1 (MDCG-1-3 to be more specific as we’re dealing with heart implants) and PMS reporting. In the guidance, they give a template table towards the end to show what the report should look like but it looks too simplified for a PMS report. For example, to report individual serious incidents, it seems we’re to report description followed by codes based on Annex E and A. But is that it? Am I to assume that no greater details regarding each incident needs to be provided in the PMS report?
I think your videos are very useful for RA. If you don't mind, I would like to ask your permission to share your videos to the other website in China for the embarrassing reason that UA-cam is blocked from accessing in China. Of course, I will give sources of the original website. Thank you very much!
Sure, happy that you share them. Please just reference our website easymedicaldevice for the credit. Thanks for your support
Why I can't access the link where I can check if English is a required language? I keep getting the error message "Access Denied"
I think they changed the link at the EU level