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Home > Medical Device made Easy Podcast > Medical Device News: December 2021 Regulatory Update


	Podcast:		Medical Device made Easy Podcast
	Episode:		Medical Device News: December 2021 Regulatory Update
	Category:		Business
	Duration:		00:00:00
	Publish Date:		2021-12-07 02:00:00
	Description:		EUDAMED Commission implementing regulation 2021/2078: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021R2078 EUDAMED webpage: https://ec.europa.eu/health/md_eudamed/udi_devices_registration_en EUDAMED Playground: https://webgate.training.ec.europa.eu/eudamed-play/landing-page#/ UDI/Devices guidance: https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_eudamed_udi-devices-user-guide_en.pdf Infographic EUDAMED: https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_eudamed-udi-concept_en.pdf Categorization of devices: https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_eudamed-devices_en.pdf Registration process: https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_eudamed-udi-registration-process_en.pdf IVDR expert panel View in the context of the Performance Evaluation Consultation Procedure (PECP): https://ec.europa.eu/health/sites/default/files/md_expertpanels/docs/pecp-ivd-2021-000002-view_en.pdf Following MDCG 2021-22 https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-22_en.pdf EU Reference laboratories (EURL) Feedback on Draft implementing regulation open until December 17th, 2021: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13272-EURL-fees_en Germany: Contact Persons for Medical Devices https://www.bfarm.de/EN/Medical-devices/Contact-persons/_artikel.html?nn=968830 Ireland – HPRA: In-house Manufacturing of in vitro diagnostic medical devices – Survey Due December 17th, 2021 http://www.hpra.ie/homepage/medical-devices/news-events/item?t=/in-house-manufacturing-of-in-vitro-diagnostic-medical-devices-stakeholder-survey&id=07891026-9782-6eee-9b55-ff00008c97d0 Ireland – HPRA: Update on the creation of Free Sale Certificate in Ireland: http://www.hpra.ie/homepage/medical-devices/news-events/item?t=/applying-for-a-certificate-of-free-sale-updated-information&id=d4731026-9782-6eee-9b55-ff00008c97d0 Annex XVI products – Finland – FIMEA https://www.fimea.fi/web/en/-/supervision-of-devices-referred-to-in-annex-xvi-of-the-medical-device-regulation-to-begin-in-autumn-2022 CHRISTMAS BREAK MHRA Christmas period: Clinical Investigation: https://www.gov.uk/guidance/notify-mhra-about-a-clinical-investigation-for-a-medical-device Belgium – FAMHP – Christmas period https://www.famhp.be/en/news/deadlines_for_the_submission_of_dossiers_during_end_of_year_period Switzerland: Registration of Economic Operators: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-access/registriernummer-chrn.html CH-RN Database: https://opendata.swiss/en/dataset/mep401-chnr-actors How to obtain the CHRN: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_11_001defi_fo-registrierungsantrag-einmalige-idnr-art55-mepv.pdf.download.pdf/BW630_11_001defi_FO_Antrag_Registrierung_CHRN.pdf Switzerland – Procurement: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/reprocessing—maintenance/beschaffung.html UK MHRA: Review launched into the health impact of potential bias in medical devices : https://www.gov.uk/government/news/review-launched-into-the-health-impact-of-potential-bias-in-medical-devices WORLD USA: Final rule for Medical Device De Novo Classification Process https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-final-rule-medical-device-de-novo-classification-process Podcast episode 43 – How to register a Medical Device with FDA? (510k, PMA, DeNovo) How to register a Medical Device with FDA? (510k, PMA, de Novo…) USA: Draft Guidance 510K Device Software function SaMD Webinar Dec 16th, 2021 – Draft Guidance: Content of Premarket Submission for Device Software functions: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-draft-guidance-content-premarket-submissions-device-software-functions-12162021-12162021 Draft guidance: https://www.fda.gov/media/153781/download USA: Voluntary eSTAR Program: https://www.fda.gov/medical-devices/premarket-notification-510k/voluntary-estar-program Non-in vitro diagnostic eStar Version 1: https://www.fda.gov/media/154429/download In Vitro Diagnostic eStar Version 1: https://www.fda.gov/media/154430/download Saudi Arabia: Borderline products https://www.sfda.gov.sa/sites/default/files/2021-11/GuidanceBorderlineProductsClassificationE.pdf Notified Body SGS Belgium: https://www.sgs.com/en/news/2021/11/sgs-belgium-nv-confirmed-as-a-notified-body-for-the-new-eu-medical-device-regulation-mdr MDR 25: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34 IVDR 2017/746 6: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35 EMD Podcast Episode 153 – How to improve your QA RA Communication with Lesley Worthington: https://podcast.easymedicaldevice.com/153/ Episode 154 – Is it possible to Private Label a Medical Device under MDR and IVDR with Erik Vollebregt: https://podcast.easymedicaldevice.com/154/ Episode 155 – How to approach your Notified Bodies? With Dr Royth von Hahn https://podcast.easymedicaldevice.com/155/ Episode 156 – Unleashing “MDR Classification surprises with Franck Matzek https://podcast.easymedicaldevice.com/156/ LinkedIn Live Talk Cybersecurity during MDR audit with Stefan Bolleininger: https://www.youtube.com/watch?v=IK0DiXnISKE&t=4s IVDR 2017/746 – in-house devices: https://www.youtube.com/watch?v=AbwaA7DpbYI The post Medical Device News: December 2021 Regulatory Update appeared first on Medical Device made Easy Podcast.
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