Medical Device News: April 2022 Update
The latest news for the Medical Device Community is on the Medical Device News Podcast. We'll talk about EU, US, MEA, Asia, Notified Bodies, Events, Podcasts. So enjoy! The post Medical Device News: April 2022 Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Medical Device made Easy Podcast
April 5, 2022
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Show Notes
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/
The post Medical Device News: April 2022 Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Topics
medicaldeviceregulationMEDTECHINDUSTRYregulatoryaffairsISO13485EUMDRMDR2017/745MedicalDeviceIndustryQualityManagementSystemFDAANVISATGAEURegulatoryComplianceAuditsNotifiedBodymeddevicetrainingcertificationbusinesstechnolo