Sponsor Medboard Medboard: https://www.medboard.com/ EUROPE Europe Starts Regulating the Regulators - Implementing Regulation (EU) 2026/977: https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj EUDAMED is mandatory - Panic is raising: https://health.ec.europa.eu/medical-devices-eudamed/overview_en Germany: https://www.bfarm.de/SharedDocs/Downloads/DE/Medizinprodukte/DMIDS-anleitung-anzeigepflichtige-mp-ivd.pdf?__blob=publicationFile Belgium: https://www.famhp.be/en/news/eudamed_clarifications_regarding_obligations_from_28_may_2026Portugal: https://www.infarmed.pt/web/infarmed/noticias/-/journal_content/56/15786/13092901 AI Medical Devices - Timeline changed for AI ACT: https://www.consilium.europa.eu/en/press/press-releases/2026/05/07/artificial-intelligence-council-and-parliament-agree-to-simplify-and-streamline-rules/ Germany guidance: https://www.bundesnetzagentur.de/DE/Fachthemen/Digitales/KI/5_Innovationen/_DL/Roadmap_Pilot.pdf?__blob=publicationFile&v=5 Spain new HTA - Royal Decree 415/2026: https://www.boe.es/boe/dias/2026/05/29/pdfs/BOE-A-2026-11587.pdf Denmark on languages - Reminder that there are requirements to follow: https://laegemiddelstyrelsen.dk/en/devices/registration-and-marketing/language-requirement/ UK MHRA regulatory advice meetings - Pay and ask what you want: https://www.gov.uk/guidance/medical-devices-ask-for-a-regulatory-advice-meeting-from-the-mhra Easy Medical Device solutions EasyIFU - electronic Instruction for Use: https://easyifu.com Smarteye - electronic Quality Management System: https://eqms-smarteye.com/ Rest of the World FDA reinforce Human Factors expectations - This is not nice to have: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-human-factors-information-medical-device-marketing-submissions Saudi Arabia bundling criteria - More products in a single application: https://www.sfda.gov.sa/sites/default/files/2026-05/MDS-G28.pdf Podcast Podcast Nostalgia - Re-listen latest podcast episodes: Episode 390 - How can a proper intended use save your device with Kanrandeep Badwal: https://podcast.easymedicaldevice.com/390-2/ Episode 391 - Feedback after 3 months of the new FDA QMSR is in place with Mathangi Srinivasan: https://podcast.easymedicaldevice.com/391-2/ Easy Medical Device Consulting activities (CE marking, Clinical Evaluation, QMS creation…) https://easymedicaldevice.com/services/mdr-ivdr-technical-documentation/ BOSS Program: Back Office Services eQMS: https://easymedicaldevice.com/smarteye-eqms/ EasyIFU: eIFU and Label creation: https://easymedicaldevice.com/easyifu/ Authorized Representative in EU, UK and Switzerland Market access all over the world: https://easymedicaldevice.com/services/market-access/ 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 This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast. Rss Apple Podcaster →
