Medical Device News, Septembre 2024 Regulatory Update

EU

• e-IFU for medical devices – Consultation ongoing: https://ec.europa.eu/eusurvey/runner/Survey_eIFUs_medicaldevices_2024?surveylanguage=EN
• MDR Transition period – Visual timeline: https://health.ec.europa.eu/document/download/06bb3982-dc01-46aa-95af-d8833c9fcb21_en?filename=timeline_mdr_en.pdf
• Implementing Act IVDR Common specifiaction – Consultation until Sept 16th: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14383-In-vitro-diagnostic-medical-devices-common-specifications_en
• Cyber Security in Health and medicine – Results from Cyber incidents: https://op.europa.eu/o/opportal-service/download-handler?identifier=9d3355cf-591f-11ef-acbc-01aa75ed71a1&format=pdf&language=en&productionSystem=cellar&part=
• How much cost a Notified Body? – Links available: https://health.ec.europa.eu/document/download/ff5716d5-fe77-4f45-b883-fcf3da4acd15_en?filename=md_nbs_fees_en.pdf

Switzerland

• Swiss Combined Studies – Information Sheet to read: https://www.swissmedic.ch/dam/swissmedic/it/dokumente/medizinprodukte/mep_urr/bw600_00_017e_mb_combined_studies.pdf.download.pdf/BW600_00_017e_MB_Information_combined_studies_KlinV_KlinVMEP.pdf
• 3D Printing for Medical Devices – Reminder from Swissmedic: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu600_00_017d_mb_3d-drucker_mep.pdf.download.pdf/MU600_00_017e_MB_3D_printers_medical_devices.pdf

Training

• EU MDR training September 23rd – Register Now: https://school.easymedicaldevice.com/course/gb33/

Events:

• RAPS Convergence – September 17th to 19th California: https://medtechconf.com/event/raps-convergence-2024/
• AI ACT SUMMIT – October 1st :Online : https://medtechconf.com/event/ai-act-summit/
• Team-PRRC – October 17th – Malaga: https://medtechconf.com/event/team-prrc-third-annual-summit/
• Afrisummit – November 3-6 – Egypt: https://www.pharmaregafrisummit.com/
• Meds’d – November 7th – Berlin: https://medtechconf.com/event/medxd-medtech-meets-digital-2024/

ROW

• Australia:
  • Webinar: Software transition deadline on 1 November 2024 Reclassification needed: https://www.tga.gov.au/resources/event/webinars/software-reclassification-reforms-webinar-q-and-software-transition-deadline-1-november-2024
• USA
  • Voluntary malfunction Summary Reporting (VSMR) – Support the system: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/voluntary-malfunction-summary-reporting-vmsr-program-manufacturers
  • FDA Webinar: Remanufacturing of Devices – Distinction between servicing and remanufacturing: https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/webinar-final-guidance-remanufacturing-medical-devices-09102024?utm_source=FDALinkedin
  • FDA DeNovo – Electronic Submission template: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-submission-template-medical-device-de-novo-requests
  • PCCP Draft Guidance – Plan your changes so they don’t need a review again: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/predetermined-change-control-plans-medical-devices
• Brazil:
  • Brazil UDI project – The world will be UDI soon: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/saiba-mais-sobre-o-projeto-de-identificacao-unica-de-dispositivos-medicos
  • Brazil Vigilance Reporting – e-Notivisa Launch: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/cidadaos-poderao-notificar-eventos-adversos-de-dispositivos-medicos-pelo-e-notivisa
• Singapore
  • Singapore Change Management Program – Consultation on SaMD Guidance: https://www.hsa.gov.sg/announcements/regulatory-updates/consultation-on-guidance-on-change-management-program-(cmp)-for-samd
• Bahrain
  • Guidance for registration of Medical Devices – Screenshot included: https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/guidelines/Medical%20Device%20Importation%20Guideline-%20Ver%2011.1.pdf

Medical Device Live Expert:

• Medical Device Live Expert – July August:
  • MDLE #2 – US EXPERT: Medical Device Live Expert #2 – US is in the place
  • MDLE #3 – EU MDR and IVDR Future: MDLE #3 – The Future of the MDR in EU, What Is?

Podcast

• Podcast Nostalgia – July and August
  • AI ACT – What are the challenges for Medical Devices? Fabien Roy https://podcast.easymedicaldevice.com/292-2/
  • EU Battery Regulation – How to be ready? Erik Vollebregt: https://podcast.easymedicaldevice.com/293-2/
  • How to register your Medical Device in the UAE? Ahmed Hendawy: https://podcast.easymedicaldevice.com/294-2/
  • EU MDR majow update: Interruption or Discontinuation of Supply! Erik Vollebregt: https://podcast.easymedicaldevice.com/295-2/
  • IVDR Class D – Lesson learned from Notified Bodies. Andreas Stange: https://podcast.easymedicaldevice.com/296-2/
  • How to use Harmonised Standards for Devices? Beat Keller: https://podcast.easymedicaldevice.com/297-2/
  • Manage the Transfer/Renewal/ Surveillance/Change of your CE Certificate. Ralf Gansel: https://podcast.easymedicaldevice.com/298-2/
  • How to grow from Zero to Hero in Medical Device? Stephan O’Rourke: https://podcast.easymedicaldevice.com/299-2/
  • Episode 300: How to use AI GPT for your QA RA work? Martin King: https://podcast.easymedicaldevice.com/300-2/