Sponsor: Medboard
https://www.medboard.com/
Europe
EUDAMED: It's Go Time -May 28th 2026 for New Products:
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32024R1860&qid=1720686388639
https://health.ec.europa.eu/document/download/04ce2012-97df-4dd0-8a39-d4f6993b9e16_en?filename=md_eudamed_roadmap_en.pdf
Brand new Notified Body Rules -Implementation regulation 2026/977
https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj
https://www.medtecheurope.org/resource-library/new-eu-rules-more-business-predictability-and-transparency-in-medtech-conformity-assessment/
EU MDR IVDR Simplification Proposal - 2 tracks
https://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2025/1023/COM_COM(2025)1023_EN.pdf
EMA Breakthrough Medical Devices Pilot - Just launched
https://www.ema.europa.eu/en/news/new-pilot-support-development-breakthrough-medical-devices
https://www.ema.europa.eu/en/documents/presentation/presentation-breakthrough-medical-devices-pilot-information-sessio_en.pdf
MIR form update - Update your files or links:
https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance/pmsv-reporting-forms_en
Switzerland
Swissdamed device Registration - July 1st is coming
https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/produktregistrierung.html
Swissmedic's 2026 PMS Focus Campaign - Class Iia, Iib and III
https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-surveillance-of-medical-devices/schwerpunktaktionen/info-ueberpruefung-dokumentation-zur-ueberwachung-nach-inverkehrbringen.html
UK
MHRA proposes indefinite CE Mark Recognition - Poll is closed
https://www.gov.uk/government/consultations/medical-devices-regulations-targeted-consultation-on-the-indefinite-recognition-of-ce-marked-devices
New UK Clinical Trials Framework -Live Since April 28th
https://www.gov.uk/government/news/launch-of-clinical-trial-reforms
New MHRA fees + Faster Incident Reporting - Reminder to budget and update procedures.
https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market#fees
https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/vigilance-reporting-requirements
MHRA Medical Devices (Amendment) Regulations 2026 - Brand New, Your Input Needed
https://www.gov.uk/government/news/mhra-invites-views-on-proposed-changes-to-medical-device-regulation
Events
Medtech Summit - June 15-16, 2026 in Berlin, Germany
https://informaconnect.com/medtech-summit
European Medical Device Supplier Excellence Conference - June 9-11th, 2026 - Brussels, Belgium
https://medicaldevicesupplierexcellence.com/
International
USA — FDA Launches - AI Platform HALO and Upgrades Elsa to 4.0
https://www.fda.gov/news-events/press-announcements/fda-expands-ai-capabilities-and-completes-data-platform-consolidation
Canada: Two changes happening — Mandatory Digital Submissions + New AI/ML Device Guidance
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/announcements/mandatory-use-regulatory-enrolment-process-notice-to-industry.html
https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/medical-devices/application-information/guidance-documents/pre-market-guidance-machine-learning-enabled-medical-devices/pre-market-guidance-machine-learning-enabled-medical-devices.pdf
Podcast
Podcast Nostalgia
Episode 384: AI Medical Devices: What Notified Bodies Really Look for (Camille Petri): https://podcast.easymedicaldevice.com/384-2/
Episode 385: The Fake QMS Problem: Why your ISO 13485 System will fail and Audit: https://podcast.easymedicaldevice.com/385-2/
Episode 386: Life after CE Marking: Why AI Medical Devices Need Continuous Monitoring (Osman El-Kouban): https://podcast.easymedicaldevice.com/386-2/
Episode 387: Master UDI-DI: The New Layer many Medtech Companies don't Understand (Hussam Mostafa): https://podcast.easymedicaldevice.com/387-2/
Episode 388: Certifying LLM-Driven medical devices (Sandy Wright): https://podcast.easymedicaldevice.com/388-2/
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/
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