Medical Device News June 2024 Regulatory Update

Medical Device made Easy Podcast

• EUROPE
  • EU MDR 26 May 2024 – Was there any apocalypse:
    • France: https://ansm.sante.fr/actualites/reglement-europeen-relatif-aux-dispositifs-medicaux-fin-de-la-periode-de-transition
    • Netherland: https://www.igj.nl/zorgsectoren/medische-technologie/nieuws/2024/05/23/fabrikanten-van-medische-hulpmiddelen-moeten-uiterlijk-26-mei-een-aanvraag-hebben-ingediend-voor-ce-certificering
  • EU shortage managed – EUDAMED and IVD extension also discussed: https://www.consilium.europa.eu/en/press/press-releases/2024/05/30/medical-devices-council-adopts-new-measures-to-help-prevent-shortages/?utm_source=brevo&utm_campaign=AUTOMATED%20-%20Alert%20-%20Newsletter&utm_medium=email&utm_id=320
  • EMA Q&A on Combination products – Do you need a Notified Body? https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu-2017-745-eu-2017-746_en.pdf
  • EU talks about SoHo -: Substances of Human Origin
    • https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:PE_8_2024_INIT&qid=1716536451356
    • https://www.consilium.europa.eu/en/press/press-releases/2024/05/27/council-adopts-new-rules-on-substances-of-human-origin/
  • Italy Database error – Updating expired (AI)MDD certificates https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=6569
  • Ireland guide on In-House IVDs – Laboratories to listen: https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/guide-for-health-institutions-who-manufacture-and-use-in-house-ivds-in-ireland-v1.pdf?sfvrsn=8
  • Combined Studies in the EU – COMBINE PROJECT:
    • https://ec.europa.eu/newsroom/sante/items/830485/en
    • https://health.ec.europa.eu/document/download/77e1409a-f4c0-45db-bff1-4873c7a0e7ae_en?filename=md_combined-analysis-phase-report.pdf
• Notified Bodies
  • Survey Result: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf
  • Team-NB Survey: https://www.team-nb.org/wp-content/uploads/2024/05/Team-NB-MD-Sector-Survey-PressRelease-20240515.pdf
  • New Notified Bodies for EU MDR –
    • MTIC InterCert Italy: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications?organizationRefeCd=EPOS_43390&filter=notificationStatusId:1
    • Kiwa Istanbul: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications/1007731?organizationVersion=18
    • QMS Services GmbH Austria: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications/1007832?organizationVersion=1

• UK
  • UK on international recognition – Approve products without CE or UKCA mark:
    • https://www.gov.uk/government/news/mhra-announces-a-proposed-framework-for-international-recognition-of-medical-devices
    • https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/statement-of-policy-intent-international-recognition-of-medical-devices
  • UK implementation of Future Regulation – When will this come in force: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/implementation-of-the-future-regulations
  • UK Common Specifications for IVD – Provide your opinion: https://www.gov.uk/government/consultations/common-specification-requirements-for-in-vitro-diagnostic-devices
  • UK suspected counterfeit Medical Device – How to report: https://www.gov.uk/government/publications/report-a-non-compliant-medical-device-enforcement-process/report-a-non-compliant-or-suspected-counterfeit-medical-device
  • UK Ai Airlock – Be ready to help the government: https://www.gov.uk/government/news/mhra-launches-ai-airlock-to-address-challenges-for-regulating-medical-devices-that-use-artificial-intelligence
    • Webinar planned July 23rd: https://www.eventbrite.co.uk/e/ai-airlock-the-regulatory-sandbox-for-aiamd-in-healthcare-webinar-tickets-896407919217

• Easy Medical Device: eQMS SmartEye
  • Video: One of the best eQMS for Medical Devices One of the best eQMS for Medical Devices

• Events:
  • Medtech Conf:
    • Title: International Medical Device Exhibition and Conference – Subtitle: Malaysia 10th to 12th December 2024 : https://medtechconf.com/event/imdec-2024-exhibition-conference/

• Training
  • Green Belt Training for EU MDR 2017/745 24th-28th June 2024: https://school.easymedicaldevice.com/gb/
  • EU Vigilance Reporting: https://school.easymedicaldevice.com/course/vigilance-reporting-eu-legislation/
  • Audit Readiness: https://school.easymedicaldevice.com/course/etraining-audit-readiness/

• WORLD
  • US
    • US Remanufacturing or Servicing – Webinar replay included:
      • https://www.fda.gov/media/150141/download
      • Webinar: https://www.fda.gov/medical-devices/medical-devices-news-and-events/webinar-final-guidance-remanufacturing-medical-devices-06272024
    • US – Use of Patient Generated Data – Medical Device Development: https://www.fda.gov/medical-devices/medical-devices-news-and-events/co-sponsored-public-workshop-using-patient-generated-health-data-medical-device-development-case
    • US Laboratory Developed Tests – Final rules defined and Webinar to explain:
      • https://www.fda.gov/medical-devices/medical-devices-news-and-events/webinar-final-rule-medical-devices-laboratory-developed-tests-05142024
      • https://www.fda.gov/medical-devices/laboratory-developed-tests/laboratory-developed-tests-frequently-asked-questions
      • https://www.fda.gov/news-events/press-announcements/fda-takes-action-aimed-helping-ensure-safety-and-effectiveness-laboratory-developed-tests
  • Australia
    • Australia – in-house IVDs requirements – Support Australian Laboratories: https://www.tga.gov.au/resources/resource/guidance/regulatory-requirements-house-ivds
    • Australia on boundary and Combination products List: https://www.tga.gov.au/sites/default/files/2024-05/examples-boundary-combination-products-and-product-category.pdf
  • Saudi Arabia
    • Saudi Arabia – Webinar Biological Evaluation – 6 June 2024 10am Saudi Time https://www.sfda.gov.sa/en/workshop/716404
  • Nigeria
    • Guidance to register Medical Devices – Registration, labelling and advertising:
      • https://nafdac.gov.ng/wp-content/uploads/Files/Resources/Regulations/Draft_Regulations_2024/Medical-Devices-and-Related-Products-Registration-Regulations-2024.pdf
      • https://nafdac.gov.ng/wp-content/uploads/Files/Resources/Regulations/Draft_Regulations_2024/Medical-Devices-and-Related-Products-Labelling-Regulations-2024.pdf
      • https://nafdac.gov.ng/wp-content/uploads/Files/Resources/Regulations/Draft_Regulations_2024/Medical-Devices-and-Related-Products-Advertisement-Regulations-2024.pdf
  • India
    • CDSCO laboratory testing – But in the Country and not outside: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTEzMTg=
  • Malaysia
    • Malaysia Guidance for Medical Device – Change Notification support: https://www.mda.gov.my/index.php/announcement/1401-public-comment-draft-guidance-document-change-notification-for-registered-medical-device
  • Hong-Kong
    • Overview of a Local Responsible Person – Who? What? When? Where?: https://www.mdd.gov.hk/filemanager/common/mdacs/GN-01-E.pdf
  • Singapore
    • Singapore Cybersecurity labelling- SAt which level is your product: https://www.csa.gov.sg/our-programmes/certification-and-labelling-schemes/cls-md

• PODCAST
  • Podcast Nostalgia – What topics were discussed
    • Episode 283: Quality Field Service for Medical Devices with Michael Israel: https://podcast.easymedicaldevice.com/283-2/
    • Episode 284: How to select and evaluate your Contract Manufacturer with Keith Smith: https://podcast.easymedicaldevice.com/284-2/
    • Episode 285: Are you Correction or Corrective Action or Preventive Action with Vincent Cafiso: https://podcast.easymedicaldevice.com/285-2/
    • Episode 286: Summative Evaluation – Common Mistakes with Amandine Broussier: https://podcast.easymedicaldevice.com/286-2/

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