Medical Device News March 2025 Regulatory Update

Sponsor

• Medboard: https://www.medboard.com/

Europe

• Health Data Legislation – Manufacturers should comply: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202500327&qid=1741166600030
  • FAQ: https://health.ec.europa.eu/document/download/4dd47ec2-71dd-49fc-b036-ad7c14f6ed68_en?filename=ehealth_ehds_qa_en.pdf
• eIFU proposal until March 21st- eIFU for professional user:  https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14470-Medical-devices-electronic-instructions-for-use_en
• 14th Notified Body Under IVDR – Centro Nacional de Certification de Productos Sanitarios: https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications?organizationRefeCd=EPOS_43640&filter=notificationStatusId:1
• Exceptional access of Non-CE Medical Devices – France simplified form: https://ansm.sante.fr/actualites/acces-derogatoire-pour-un-dispositif-medical-depourvu-de-marquage-ce-optimisation-du-processus-de-demande-a-lansm
• EMA scientific Advice for High-risk device – Portal available: https://www.ema.europa.eu/en/news/ema-establishes-regular-procedure-scientific-advice-certain-high-risk-medical-devices
  • Guide: https://www.ema.europa.eu/en/documents/other/guide-manufacturers-procedure-requesting-advice-expert-panels-clinical-investigations-or-clinical-development-strategies-high-risk-medical-devices_en.pdf
• IGJ on Generative AI in Healthcare – Be careful: https://www.igj.nl/zorgsectoren/medische-technologie/publicaties/publicaties/2025/02/10/igj-roept-zorgaanbieders-op-ga-zorgvuldig-om-met-invoering-van-generatieve-ai-toepassingen
• Pilot for Clinical Investigation and Performance Study – 1 application for all member states: https://health.ec.europa.eu/medical-devices-clinical-investigations-and-performance-studies/pilot-coordinated-assessment-cips_en
  • FAQ: https://health.ec.europa.eu/document/download/7ee00635-08dd-4c24-b892-74fc8eebfb54_en?filename=md_ci_pilot-ci-ps_faq_0.pdf
  • Participating member states: https://health.ec.europa.eu/document/download/e987dcf9-cc8c-44c4-b772-18919cd3f84c_en?filename=md_ci_pilot-ci-ps_ms-pilot-coordinated-assessment.pdf
• What is an AI system – Read the guide: https://digital-strategy.ec.europa.eu/en/library/commission-publishes-guidelines-ai-system-definition-facilitate-first-ai-acts-rules-application

Switzerland

• Swissmedic assessment on PMS – Result is BAD: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-surveillance-of-medical-devices/schwerpunktaktionen/ueberpruefung-dokumentation-ueberwachung-nach-inverkehrbringen-smc.html

UK

• IVD registration in the UK – Transition to IVDR: https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market
  • EU IVDD Extension:  https://www.gov.uk/government/publications/registration-of-in-vitro-diagnostic-devices-with-expiring-ce-certificates/registration-of-certain-in-vitro-diagnostic-devices
• Reliance on Exention of CE- Reusable Class I devices : https://www.gov.uk/government/publications/registration-of-reusable-or-upclassified-class-i-devices-andor-expiring-ce-certificates/registration-of-certain-medical-devices-which-are-reusable-class-i-devices-upclassified-class-i-devices-andor-reliant-on-expiredexpiring-ce-certif#reliance-on-extended-certificates-in-great-britain-gb–

Webinar

• 28 March – AI in Healthcare – EU priorities and Ecosystem Synergies: https://digital-strategy.ec.europa.eu/en/events/ai-healthcare-eu-priorities-and-ecosystem-synergies

Newsletter

• Easy Medical Device Newsletter – Get fresh information: https://www.linkedin.com/posts/easymedicaldevice_medicaldevices-mdr-regulatorycompliance-activity-7304455925044531200-mKt0?utm_source=share&utm_medium=member_desktop&rcm=ACoAAABZ07ABDocaBMTLJo8bsl8V3bgNSBIiZuI
• Medtech Leading Voice Newsletter –  Reference a lot of Medical Device posts: https://www.linkedin.com/newsletters/medtech-leading-voice-6871913764770324480/

ROW

• Australia: Ask consent if product not compliant – Not compliant to the Essential Principles: https://www.tga.gov.au/resources/resource/reference-material/consent-medical-devices-do-not-meet-essential-principles
• South Africa: Classification rules – Some rules were updated: https://www.sahpra.org.za/wp-content/uploads/2022/01/SAHPGL-MD-04_v5-Guideline-for-Classification-of-MD-and-IVDs.pdf
• Application to Canada – Draft guidance: https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/medical-devices/application-information/guidance-documents/managing-applications-licenses/draft-guidance-on-managing-applications-for-medical-device-licences-eng.pdf

Podcast

• Episode 323 – The good, the bad and the ugly of certification bodies with Mark Rogovoi; https://podcast.easymedicaldevice.com/323-2/
• Episode 324 – How and who to build your Risk Management File with Bijan Elahi: https://podcast.easymedicaldevice.com/324-2/
• Episode 325 – FDA: Advantage of the Breakthrough Device Program with Michelle Lott: https://podcast.easymedicaldevice.com/325-2/
• Episode 326 – How to avoid Clinical Investigation for your Device with Hatem Rabeh: https://podcast.easymedicaldevice.com/326-2/

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