Medical Device News – January 2022 [Happy New Year]

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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