Medical Device News – January 2022 [Happy New Year]

HAPPY NEW YEAR 2022! Another year passed and this went really fast. But the Medical Device News is still here. So today we will talk of all the releases done in December 2021 and what is planned for the following months. Don't miss it. This will save you a lot of time.

The post Medical Device News – January 2022 [Happy New Year] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Happy New Year 2022. All my best wishes for this year. For all the updates. check the links below.

Links:

Green Belt Edition 15 – January 2022: http://school.easymedicaldevice.com/course/gb15/ Progressive Roll-out of the In Vitro Diagnostic Medical Devices Regulation: https://ec.europa.eu/commission/presscorner/detail/en/IP_21_6965 02 Expert Panel Review: Screen donor samples for HEV RNA in plasma samples https://ec.europa.eu/health/sites/default/files/md_expertpanels/docs/pecp-ivd-2021-000002-view_en.pdf 03 Expert Panel Review: Detection of West Nile Virus (WNV) RNA in plasma and serum specimens. https://ec.europa.eu/health/sites/default/files/md_expertpanels/docs/pecp-ivd-2021-000003-view_en.pdf 04 Expert Panel Review: Test for direct detection of Babesia DNA and RNA in whole blood samples: https://ec.europa.eu/health/sites/default/files/md_expertpanels/docs/pecp-ivd-2021-000004-view_en.pdf 05 Expert Panel Review: Qualitative in-vitro nucleic acid screening test for the direct detection of ZIKA virus RNA in human plasma [RECOMMENDATION PROVIDED]: https://ec.europa.eu/health/sites/default/files/md_expertpanels/docs/pecp-ivd-2021-000005-view_en.pdf MDCG 2022 meetings: https://ec.europa.eu/health/sites/default/files/md_dialogue/docs/md_events_2022_en.pdf Team NB Position paper on MDR/IVDR Implementation: https://www.team-nb.org/wp-content/uploads/2021/12/Team-NB-PositionPaper-on-MDR_IVDR-Implementation-V2.pdf eIFU: https://eur-lex.europa.eu/eli/reg_impl/2021/2226/oj The Fast-Track Process for DiGA: https://www.bfarm.de/SharedDocs/Downloads/EN/MedicalDevices/DiGA_Guide.pdf?__blob=publicationFile Swissmedic Simplifies labeling Obligations: https://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizinprodukte/mep_urr/mu600_00_016d_mb_pflichten_wirtschaftsakteure_ch.pdf.download.pdf/MU600_00_016d_MB_Pflichten_Wirtschaftsakteure_CH.pdf QUNIQUE translation: https://lnkd.in/ghreiitJ Swiss notification mandate form updated: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/overview-medical-devices/formular-mandat-chrep.html Medsun December 2021: Reporting of problems from 300 hospitals, nursing homes, and home health facilities in the USA. https://www.fda.gov/media/154761/download Medical Device Regulation Overview and update – Eng Abdullah Alghuraibi: http://www.ahwp.info/sites/default/files/Annex18_Saudi%20Arabia%20updates.pdf DoC template: https://www.sfda.gov.sa/sites/default/files/2021-12/MDMA-Annex15v6.docx EU: MDCG 2021-27 Questions and answers on article 13 & 14 of MDR & IVDR: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-27_en.pdf Erik Vollebregt Article: https://medicaldeviceslegal.com/2021/12/28/mdcg-2021-27-qa-on-importers-and-distributors-sort-of-box-of-chocolates/ EU: MDCG 2021-28 Substantial modification of clinical investigation under Medical Device Regulation: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-28_en.pdf TÜV NORD CERT GmbH: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=315449&version_no=26 Episode 158: Which devices cannot be Custom-made [Erik Vollebregt]: https://podcast.easymedicaldevice.com/158/ Episode 159: The Step-by-step recipe to get MDR and IVDR certified: https://podcast.easymedicaldevice.com/159/ Episode 160: What happened in 2021: https://podcast.easymedicaldevice.com/160/

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The post Medical Device News – January 2022 [Happy New Year] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi