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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