Medical Device News, Septembre 2024 Regulatory Update

EU

e-IFU for medical devices - Consultation ongoing: https://ec.europa.eu/eusurvey/runner/...

MDR Transition period - Visual timeline: https://health.ec.europa.eu/document/...

Implementing Act IVDR Common specifiaction - Consultation until Sept 16th: https://ec.europa.eu/info/law/better-...

Cyber Security in Health and medicine - Results from Cyber incidents: https://op.europa.eu/o/opportal-servi...

How much cost a Notified Body? - Links available: https://health.ec.europa.eu/document/...

Switzerland

Swiss Combined Studies - Information Sheet to read: https://www.swissmedic.ch/dam/swissme...

3D Printing for Medical Devices - Reminder from Swissmedic: https://www.swissmedic.ch/dam/swissme...

Training

EU MDR training September 23rd - Register Now: https://school.easymedicaldevice.com/...

Events:

RAPS Convergence - September 17th to 19th California: https://medtechconf.com/event/raps-co...

AI ACT SUMMIT - October 1st :Online : https://medtechconf.com/event/ai-act-...

Team-PRRC - October 17th - Malaga: https://medtechconf.com/event/team-pr...

Afrisummit - November 3-6 - Egypt: https://www.pharmaregafrisummit.com/

Meds'd - November 7th - Berlin: https://medtechconf.com/event/medxd-m...

ROW

Australia:

Webinar: Software transition deadline on 1 November 2024 Reclassification needed: https://www.tga.gov.au/resources/even...

USA

Voluntary malfunction Summary Reporting (VSMR) - Support the system: https://www.fda.gov/regulatory-inform...

FDA Webinar: Remanufacturing of Devices - Distinction between servicing and remanufacturing: https://www.fda.gov/news-events/fda-m...

FDA DeNovo - Electronic Submission template: https://www.fda.gov/regulatory-inform...

PCCP Draft Guidance - Plan your changes so they don't need a review again: https://www.fda.gov/regulatory-inform...

Brazil:

Brazil UDI project - The world will be UDI soon: https://www.gov.br/anvisa/pt-br/assun...

Brazil Vigilance Reporting - e-Notivisa Launch: https://www.gov.br/anvisa/pt-br/assun...

Singapore

Singapore Change Management Program - Consultation on SaMD Guidance: https://www.hsa.gov.sg/announcements/...

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...

EU Battery Regulation - How to be ready? Erik Vollebregt: https://podcast.easymedicaldevice.com...

How to register your Medical Device in the UAE? Ahmed Hendawy: https://podcast.easymedicaldevice.com...

EU MDR majow update: Interruption or Discontinuation of Supply! Erik Vollebregt: https://podcast.easymedicaldevice.com...

IVDR Class D - Lesson learned from Notified Bodies. Andreas Stange: https://podcast.easymedicaldevice.com...

How to use Harmonised Standards for Devices? Beat Keller: https://podcast.easymedicaldevice.com...

Manage the Transfer/Renewal/ Surveillance/Change of your CE Certificate. Ralf Gansel: https://podcast.easymedicaldevice.com...

How to grow from Zero to Hero in Medical Device? Stephan O'Rourke: https://podcast.easymedicaldevice.com...

Episode 300: How to use AI GPT for your QA RA work? Martin King: https://podcast.easymedicaldevice.com...