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Home > Medical Device made Easy Podcast > Medical Device News APRIL 2026 Regulatory Update


	Podcast:		Medical Device made Easy Podcast
	Episode:		Medical Device News APRIL 2026 Regulatory Update
	Category:		Business
	Duration:		00:00:00
	Publish Date:		2026-04-01 23:41:22
	Description:		Medboard Sponsor: Medboard: https://www.medboard.com/ EU Extension of WET Class Iib – A new list with new products mentioned: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=PI_COM:C(2026)1809 Update your MIR form – Version 7.3.1: https://health.ec.europa.eu/document/download/e8ce9f53-82cb-44c8-a06e-91ad71c16b01_en?filename=md_new-reg_mir-form-v7.3.1_en.pdf UK Future Regulation -Implementation: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/implementation-of-the-future-regulations Consultation on indefinite recognition of CE marked medical devices and current transitional arrangements Pre-market Statutory Instrument (SI) Future Enhancemens: Exceptional Use Authorization and Health Institution exemption Post-market Surveillance Requirements Update to guidances Learn Clinical Investigation in the UK – Lot of questions answered: Clinical investigations for electrically powered devices : https://www.gov.uk/government/publications/clinical-investigations-for-electrically-powered-devices/clinical-investigations-for-electrically-powered-devices Clinical investigations: investigators’ responsibilities : https://www.gov.uk/government/publications/clinical-investigations-investigators-responsibilities/guidance-for-clincal-investigators Clinical investigations: statistical considerations : https://www.gov.uk/government/publications/clinical-investigations-statistical-considerations/statistical-considerations Medical devices that need a clinical investigation: https://www.gov.uk/government/publications/medical-devices-that-need-a-clinical-investigation Determining if Clinical Investigation is required: https://www.gov.uk/government/publications/medical-devices-that-need-a-clinical-investigation/determining-if-a-clinical-investigations-is-required Clinical Investigation Flow chart: https://assets.publishing.service.gov.uk/media/696f850b5b6060ca6736a0ae/flow_chart_for_clinical_investigations_v3.png Events Team NB: Training IVDR -July 2nd 2026: https://www.team-nb.org/wp-content/uploads/2026/03/Leaflet-IVD-TD-Manufacturers-Training-20260702.pdf Egypt: Vigilance reporting Training – April 7 to 9, 2026: https://tinyurl.com/emdpodcast MedtechConf.com – Check the MAP EU Swiss Medtech Day 2026 – June 10, 2026: https://medtechconf.com/event/why-swiss-medtech-day-matters-what-you-should-know/ Medtech Forum – May 11, 2026: https://medtechconf.com/event/the-medtech-forum-2026-shaping-the-future-of-medical-technology-in-europe/ US Veeva Medtech US Summit- May 11. 2026: https://medtechconf.com/event/veeva-medtech-us-summit-2026-innovation-data-modernization-in-medical-devices/ Brazil Hospitalar – May 19,2026: https://medtechconf.com/event/hospitalar-the-reference-event-for-healthcare-innovation-and-solutions-in-latin-america/ RoW Australia: Software Advertisment -What to say: https://www.tga.gov.au/resources/guidance/advertising-software-based-medical-devices-australia Your advertisement must contain: an accurate description of the device the trade name of the device the intended purpose(s) of the device any mandatory statements and, where relevant, health warnings. For example, you must not: claim your product is “TGA approved” make unsubstantiated claims about the product’s performance include endorsements or testimonials from health professionals or medical researchers. Malaysia: Guidance Creation/Update – Medical Device Act 2012 Guidance on Definition of Medical Devices: https://portal.mda.gov.my/index.php/announcement/1777-publication-of-second-edition-of-guidance-document-on-definition-of-medical-devices Guidance on confirmation of obsolete and discontinued medical device: https://portal.mda.gov.my/index.php/announcement/1778-publication-of-first-edition-of-guidance-document-on-application-for-confirmation-status-of-obsolete-and-discontinued-medical-devices Guidance on import and/or supply of unregistered medical devices under special access exemption application: https://portal.mda.gov.my/index.php/announcement/1779-publication-of-third-edition-of-guidance-document-on-import-and-or-supply-of-unregistered-medical-devices-under-special-access-exemption-application India: FAQ on IVD products – 24 questions with answers: https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/Addendum-Doc-No-CDSCOIVDFAQ-042022dated-13032026.pdf Egypt: What you need to register – List of documents: https://tinyurl.com/EmdEgyptRegistration Podcast Podcast Nostalgia -Let’s remember: https://podcast.easymedicaldevice.com/ Episode 381: EUDAMED deadline 2026: https://podcast.easymedicaldevice.com/381-2/ Episode 382: Best-of of 3 podcasts: https://podcast.easymedicaldevice.com/382-2/ Service New Website: https://easymedicaldevice.com Authorized Representative Consulting Training EasyIFU: https://easyifu.com Smarteye: https://eqms-smarteye.com/ The post Medical Device News APRIL 2026 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
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