Medical Device News: February 2023 Regulatory Update

Medical Device made Easy Podcast

Here is your Regulatory Update for the month of February 2023. Check all the links below

– EU amendment of the EU MDR and IVDR: https://health.ec.europa.eu/medical-devices-sector/new-regulations_en – Proposal for extension consultation: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13684-Medical-devices-transition-period-extension_en – Q&A: https://ec.europa.eu/commission/presscorner/detail/en/QANDA_23_24 – General Secretariat: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:ST_5585_2023_INIT – Vote: https://eur-lex.europa.eu/procedure/EN/2023_5?qid=1675093438485&rid=1

– EU Coverage of MDR code: https://health.ec.europa.eu/latest-updates/update-coverage-designation-codes-mdrivdr-notified-bodies-january-2023-2023-01-13_en

– EU list of Standard Fees for Notified Bodies: https://health.ec.europa.eu/latest-updates/mdcg-2023-2-list-standard-fees-january-2023-2023-01-12_en

– EU Delegated directive for exemption for lead as a thermal stabilizer in Polyvinyl Chloride used as base material in sensors used in in-vitro diagnostic medical devices: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13594-Electrical-equipment-lead-in-polyvinyl-chloride-for-sensors-used-in-diagnostic-medical-devices-RoHS-exemption-_en

– MDCG 2023-1 Guidance on the health institution exemption under Article 5(5) of EU MDR and IVDR: https://health.ec.europa.eu/system/files/2023-01/mdcg_2023-1_en.pdf

– Annual overview of devices subject to the clinical Evaluation Consultation Procedure (CECP): https://health.ec.europa.eu/latest-updates/annual-overview-devices-subject-clinical-evaluation-consultation-procedure-cecp-april-2021-june-2022-2023-01-23_en

– Training EU MDR 2017/745: https://school.easymedicaldevice.com/course/gb24

– UK government response to the consultation on Medical Device Regulation: https://www.gov.uk/government/publications/government-response-to-the-rhc-report-on-medical-devices

– UK MHRA increases UK assessment capacity for In-Vitro diagnostic devices: https://www.gov.uk/government/news/mhra-increases-uk-assessment-capacity-for-in-vitro-diagnostic-devices

– Swiss – FAQ on Medical Devices: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_30_009d_mb_faq_mep_notifikationen.pdf.download.pdf/BW630_30_009e_MB_FAQ_Notifications.pdf

– Notified Bodies SLG Prüf und Zertifisierungs – 37 – EU MDR https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=321000&version_no=11 https://www.slg.de.com/home.html EU MDR 37: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34 IVDR 8: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35

– Saudi Arabia: Guidance AI/ML Software based: https://www.sfda.gov.sa/sites/default/files/2023-01/MDS-G010ML.pdf

– Leading Voices in Medtech: https://lnkd.in/eUJcAQxE https://www.linkedin.com/posts/melazzouzi_medtech-easymedicaldevice-medicaldevices-activity-7025727213714997248-plJX?utm_source=share&utm_medium=member_desktop

Podcast episodes:

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