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

[email protected]

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

[email protected]

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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