07.04.2023 - By easymedicaldevice
Sponsor Medboard https://www.medboard.com/
EU
Annex XVI transition
EU MDR Domino is making more falls. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R1194New Timeline
Until 31 December 2029
Cybersecurity and privacy in AI
Medical imaging diagnosis https://www.enisa.europa.eu/publications/cybersecurity-and-privacy-in-ai-medical-imaging-diagnosisANSM wants barcode on Field Safety Notice
Why not all the other countries
https://ansm.sante.fr/actualites/lansm-demande-aux-fabricants-de-dispositifs-medicaux-qui-envoient-un-avis-de-securite-dy-apposer-le-code-barres-des-dispositifs-concernes
AEMPS clinical trials involving drugs and medical devices
What are the rules if your device is not CE marked
https://www.aemps.gob.es/informa/la-aemps-informa-sobre-el-procedimiento-a-seguir-en-los-ensayos-clinicos-que-impliquen-medicamentos-y-productos-sanitarios/
Switzerland
Medicinal products with a medical device component
rules for combination products
https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/am-mit-mepkomponente-uebergangsbestimmungen.html
UK
Implementation of the Future Regulations
Should you focus on UKCA?
https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period/implementation-of-the-future-regulations
eQMS
Do you need an eQMS?
Let me introduce Smarteye: https://smart-eye.io
So contact [email protected] to get a demo
USA
Premarket notification for Software
What is different with Premarket submission for hardware
https://www.fda.gov/media/153781/download
Webinar - Final Guidance: Content of Premarket Submissions for Device Software Functions https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-final-guidance-content-premarket-submissions-device-software-functions-07202023
Australia
TGA Use of market authorisation evidence
Comparable overseas regulators https://www.tga.gov.au/resources/resource/guidance/use-market-authorisation-evidence-comparable-overseas-regulators-assessment-bodies-medical-devices-including-ivds
Malaysia
Malaysia rules on EU MDR extension
Letter needed
https://www.mda.gov.my/announcement/1224-announcement-mda-approach-on-expired-ec-certificate-for-new-registration-and-re-registration-of-medical-device.html
Saudi Arabia
Saudi Arabia Webinars
AI and Classification are on the spotlightArtificial Intelligence and Software Based on Medical Device https://www.sfda.gov.sa/en/workshop/88535
Introducing the Rules for Classifying the Risk of Medical Devices https://www.sfda.gov.sa/en/workshop/88536
Authorized Representative
Do you need an Authorized Representative
Service: easymedicaldevice.com
Podcast Nostalgia:
Podcast Nostalgia
What was presented in June.
The great Misunderstanding with Florian Tolkmitt: https://podcast.easymedicaldevice.com/236-2/
How to connect Software dev and QARA team with Christophe Girargey Wega: https://podcast.easymedicaldevice.com/237-2/
What should you know on the UKCA extension with Alex Denoon: https://podcast.easymedicaldevice.com/238-2/
Easy Medical Device Support
Thanks for your support
If you need us to perform your own Regulatory Update, don't hesitate to contact us at [email protected]
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particuarly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
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