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_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_2026
- Portugal: 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/
- 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
