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Medical Device News, Septembre 2024 Regulatory Update
MP3•Episode home
Manage episode 439044978 series 2591977
Content provided by Monir El Azzouzi. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Monir El Azzouzi or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.
![Miniature Medical Device News, Septembre 2024 Regulatory Update easy medical device monir el azzouzi](https://podcast.easymedicaldevice.com/wp-content/uploads/2024/09/miniature-episode-301-Low-1024x576.jpg)
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/
![podcast Medical Device News, Septembre 2024 Regulatory Update easy medical device monir el azzouzi](https://podcast.easymedicaldevice.com/wp-content/uploads/2024/09/LinkedIN_episode-301-2x3-Low.jpg)
The post Medical Device News, Septembre 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
310 episodes
MP3•Episode home
Manage episode 439044978 series 2591977
Content provided by Monir El Azzouzi. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Monir El Azzouzi or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.
![Miniature Medical Device News, Septembre 2024 Regulatory Update easy medical device monir el azzouzi](https://podcast.easymedicaldevice.com/wp-content/uploads/2024/09/miniature-episode-301-Low-1024x576.jpg)
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/
![podcast Medical Device News, Septembre 2024 Regulatory Update easy medical device monir el azzouzi](https://podcast.easymedicaldevice.com/wp-content/uploads/2024/09/LinkedIN_episode-301-2x3-Low.jpg)
The post Medical Device News, Septembre 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
310 episodes
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