Medical Device News June 2026 Regulatory Update

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_imp... EUDAMED is mandatory - Panic is raising: https://health.ec.europa.eu/medical-d... Germany: https://www.bfarm.de/SharedDocs/Downl... Belgium: https://www.famhp.be/en/news/eudamed_... Portugal: https://www.infarmed.pt/web/infarmed/... AI Medical Devices - Timeline changed for AI ACT: https://www.consilium.europa.eu/en/pr... Germany guidance: https://www.bundesnetzagentur.de/DE/F... Spain new HTA - Royal Decree 415/2026: https://www.boe.es/boe/dias/2026/05/2... Denmark on languages - Reminder that there are requirements to follow: https://laegemiddelstyrelsen.dk/en/de...   UK: MHRA regulatory advice meetings - Pay and ask what you want: https://www.gov.uk/guidance/medical-d...   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-inform... Saudi Arabia bundling criteria - More products in a single application: https://www.sfda.gov.sa/sites/default...   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... Episode 391 - Feedback after 3 months of the new FDA QMSR is in place with Mathangi Srinivasan: https://podcast.easymedicaldevice.com... Easy Medical Device Consulting activities (CE marking, Clinical Evaluation, QMS creation…) https://easymedicaldevice.com/service... BOSS Program: Back Office Services eQMS: https://easymedicaldevice.com/smartey... 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/service...