Medical Device made Easy Podcast

Medical Device News: April 2022 Regulatory Update

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HOT TOPIC

  • Joint implementation and preparedness plan for Regulation 2017/746: https://lnkd.in/dasedpRA
  • MDCG 2019-9 Rev 1 – SSCP update https://ec.europa.eu/health/document/download/5f082b2f-8d51-495c-9ab9-985a9f39ece4_en?filename=md_mdcg_2019_9_sscp_en.pdf
  • EU Handover of Experts Panels to EMA: https://ec.europa.eu/health/latest-updates/handover-experts-panels-secretariat-2022-03-02_en
  • SNITEM and BVMED ask for 2 additional years for the MDR transition period: https://www.bvmed.de/de/bvmed/presse/pressemeldungen/bvmed-und-snitem-starten-deutsch-franzoesische-initiative-zur-mdr-wir-muessen-jetzt-handeln
  • Swissmedic: Database for registering Economic Operators and Medical Devices: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank.html
  • AEMPS. Prior operating license for medical devices: https://www.aemps.gob.es/informa/notasinformativas/productossanitarios/2022-ps/nueva-instruccion-de-la-aemps-sobre-el-procedimiento-de-licencia-previa-de-funcionamiento-de-instalaciones-de-productos-sanitarios/
  • US MEDSUN: https://www.fda.gov/media/156691/download
  • China: Guidelines for registration and review of Artificial Intelligence Medical Devices: https://www.cmde.org.cn/CL0112/25219.html
  • Egypt: Guideline for labeling data on medical supplies: https://edaegypt.gov.eg/media/q23cqi5w/minimum-label-req-english-version_nancy-fateen.pdf

    • Events

    • Team PRRC Webinar April 12th, Sanctions if non-compliance to the regulation? https://www.linkedin.com/posts/team-prrc_mdr-ivdr-prrc-activity-6914642561617833985-5Moe
  • Medtech Forum 3-5 May 2022: https://www.themedtechforum.eu/
  • Green Belt Certification program
    • French April 18th until April 22nd: https://school.easymedicaldevice.com/course/gbfr3/
  • English April 25th, until April 29th: https://school.easymedicaldevice.com/course/gb18/

    • Notified Bodies

    • SIQ Slovenia Institute of Quality and Metrology: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=316903&version_no=12

    EMD

    • Episode 170 – Why do we need the Common Specification for Class D IVDR [Andreas Stange] https://podcast.easymedicaldevice.com/170/
  • Episode 171 – What lesson did we learn doing Clinical Evaluations? [Cesare Magri] https://podcast.easymedicaldevice.com/171/
  • Episode 172 – How to sell Medical Devices online in the EU and US? [Michael Wetherington] https://podcast.easymedicaldevice.com/172/
  • Episode 173 – What are the surprises during the MDR & IVDR transition [Erik Vollebregt] https://podcast.easymedicaldevice.com/173/
    • ...more
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