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Home > Medical Device made Easy Podcast > Medical Device News -June 2023 regulatory update


	Podcast:		Medical Device made Easy Podcast
	Episode:		Medical Device News -June 2023 regulatory update
	Category:		Business
	Duration:		00:00:00
	Publish Date:		2023-06-08 00:00:00
	Description:		Sponsor MedBoard: www.medboard.com EUROPE Notified Body overview: https://health.ec.europa.eu/system/files/2023-05/notifiedbodies_overview_en.pdf EU MDR and IVDR consolidated versions EU MDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20230320 EU IVDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20230320 Confirmation letter: EU Commission: https://health.ec.europa.eu/latest-updates/template-nb-confirmation-letter-framework-regulation-eu-2023607-2023-05-24_en MDCG 2020-3 Significant changes: https://health.ec.europa.eu/latest-updates/update-mdcg-2020-3-rev1-guidance-significant-changes-regarding-transitional-provision-under-article-2023-05-12_en Update Annex XVI timeline: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=PI_COM:Ares(2023)3232054 EMDN maintenance project launched: https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=6262 Spain: AEMPS and CNCps recognize the need to demonstrate to third parties the validity of expired certificates: https://www.aemps.gob.es/informa/la-aemps-informa-sobre-el-nuevo-procedimiento-del-cncps-para-confirmar-la-validez-de-los-certificados-emitidos-conforme-a-mdd/ Finland: RoHS is also applicable to Medical Devices: https://www.fimea.fi/web/en/-/rohs-act-also-concerns-medical-devices Training: Green Belt Certification Program June 26th until June 30th. https://school.easymedicaldevice.com/course/gb26 Switzerland Incident reporting Incident report for economic operators: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu680_20_009d_wl_mdv_vorkommnis_hersteller_mepv.pdf.download.pdf/MU680_20_009e_WL%20Incident%20economic%20operators.pdf Incident report for users: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu680_20_008d_wl-vorkommnismeldung-anwender.pdf.download.pdf/MU680_20_008e_WL%20incident%20report%20user.pdf Designation of a Vigilance contact person for hospitals: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu680_10_007d_wl-vigilance-kontaktperson-medizinprodukte.pdf.download.pdf/MU680_10_007e_WL%20Vigilance%20contact%20person%20for%20medical%20devices.pdf United Kingdom New tutorial videos MHRA “How to register medical devices”: https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market New Regulatory Pathway IDAP: https://www.gov.uk/government/news/new-regulatory-pathway-set-to-support-safe-patient-access-to-innovative-medical-technologies Assistive Technology: https://www.gov.uk/government/publications/assistive-technology-definition-and-safe-use/assistive-technology-definition-and-safe-use Report Adverse incidents for Software: https://www.gov.uk/government/publications/reporting-adverse-incidents-involving-software-as-a-medical-device-under-the-vigilance-system/guidance-for-manufacturers-on-reporting-adverse-incidents-involving-software-as-a-medical-device-under-the-vigilance-system   ROW Australia: Guidance on applying the Advertising Code rules: https://www.tga.gov.au/how-we-regulate/advertising/how-advertise/advertising-guidance/resources/resource/guidance/guidance-applying-advertising-code-rules Canada: Consultation on proposed amendments to the Medical Devices Regulations and Food and Drug Regulations: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/consultation-proposed-amendments-medical-devices-food-drug-regulations.html India: CDSCO updated list of Laboratories for conducting Performance Evaluation of In – Vitro Diagnostic Medical Device        : https://cdsco.gov.in/opencms/opencms/en/Notifications/Public-Notices/ Egypt: European Parliament Decision of March 2023 regarding the transitional grace periods granted in relation to the application of MDR&IVDR rules and procedures: https://www.edaegypt.gov.eg/ar/%D8%A7%D9%84%D9%85%D8%B1%D9%83%D8%B2-%D8%A7%D9%84%D8%A7%D8%B9%D9%84%D8%A7%D9%85%D9%89/%D8%A7%D9%84%D8%A5%D8%B9%D9%84%D8%A7%D9%86%D8%A7%D8%AA/%D9%82%D8%B1%D8%A7%D8%B1-%D8%A7%D9%84%D8%A8%D8%B1%D9%84%D9%85%D8%A7%D9%86-%D8%A7%D9%84%D8%A3%D9%88%D8%B1%D9%88%D8%A8%D9%8A-%D8%A7%D9%84%D8%B5%D8%A7%D8%AF%D8%B1-%D9%81%D9%89-%D9%85%D8%A7%D8%B1%D8%B3-2023-%D8%A7%D9%84%D8%AE%D8%A7%D8%B5-%D8%A8%D8%A7%D9%84%D9%85%D9%87%D9%84-%D8%A7%D9%84%D8%A5%D9%86%D8%AA%D9%82%D8%A7%D9%84%D9%8A%D8%A9-%D8%A7%D9%84%D9%85%D9%85%D9%86%D9%88%D8%AD%D8%A9-%D8%A8%D8%AE%D8%B5%D9%88%D8%B5-%D8%AA%D8%B7%D8%A8%D9%8A%D9%82-%D9%82%D9%88%D8%A7%D8%B9%D8%AF-%D9%88%D8%A5%D8%AC%D8%B1%D8%A7%D8%A1%D8%A7%D8%AA-mdr-ivdr/ Saudi Arabia Webinar: Explain The Essential Principles of Safety and Performance for Medical Devices: https://www.sfda.gov.sa/en/workshop/88451 Risk Management for Medical Devices: ISO 14971 Requirements https://www.sfda.gov.sa/en/workshop/88450 Podcast Podcast 231: The truth about the UK vs EU situation with Claire Dyson: https://podcast.easymedicaldevice.com/231-2/ Podcast 232: Technical File inconsistencies identified by Notified Bodies with Adam Rae: https://podcast.easymedicaldevice.com/232-2/ Podcast 233: What if your Medical Device company goes bankrupt with Karandeep Badwal: https://podcast.easymedicaldevice.com/233-2/ Podcast 234: How to master Regulatory Intelligence with Ivan Perez Chamorro: https://podcast.easymedicaldevice.com/234-2/ Ask Easy Medical Device . We can help you Contact at info@easymedicaldevice.com Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/ Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424   The post Medical Device News -June 2023 regulatory update appeared first on Medical Device made Easy Podcast. hamza benafqir
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