Medical Device News – July 2023 Regulatory Update

• Sponsor Medboard https://www.medboard.com/

EU

• Annex XVI transition https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R1194
• Cybersecurity and privacy in AI https://www.enisa.europa.eu/publications/cybersecurity-and-privacy-in-ai-medical-imaging-diagnosis
• ANSM wants barcode on Field Safety Notice 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 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 https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/am-mit-mepkomponente-uebergangsbestimmungen.html

UK

• Implementation of the Future Regulations 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? https://smart-eye.io
  • So contact info@scube-technologies.com to get a demo

USA

• Premarket notification for Software 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 authorization evidence 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 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
  • Artificial 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

• Europe. https://easymedicaldevice.com/eu-rep/
• UK: https://easymedicaldevice.com/uk-responsible-person/
• Switzerland: https://easymedicaldevice.com/swiss-authorised-representative/

Podcast Nostalgia:

• 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/

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