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/