Medical Device News, October 2024 Regulatory Update

Medboard: https://www.medboard.com/

EUROPE

• TEAM NB – Code of Conduct for NB – Version 5: https://www.team-nb.org/wp-content/uploads/2024/09/PressRelease-CoC-20240916.pdf
• TEAM NB – IVDR Transition – Transition to the implementation of Class D oversight by EURLs: https://www.team-nb.org/wp-content/uploads/2024/10/PressRelease-ClassD-20241001.pdf
• MDCG 2021-4 Rev 1 update- Deletion, revision, addition of questions: https://health.ec.europa.eu/document/download/9f23fca0-f407-4e45-a464-2d71b575d1fe_en?filename=mdcg_2021-4_en.pdf
• Swissmedic – Deadline for Swissdamed – November 13th, 2024: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/overview-medical-devices/archive/swissdamed/swissdamed-frist-13-11-24.html
• Swiss review of old legislation devices – Check that all are up-to-date: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/overview-medical-devices/aufforderung-ueberpruefung-altrechtlicher-produkte.html
• UK on their new Regulation – Restart ongoing: https://medregs.blog.gov.uk/2024/09/25/an-update-on-our-plans-for-med-tech-regulatory-change/

EVENTS

• TEAM-PRRC – October 17-18. 2024: https://medtechconf.com/event/team-prrc-third-annual-summit/
• Afrisummit – November 3-6, 2024: https://medtechconf.com/event/afrisummit/
• MEDICA – November 11-14, 2024 : https://medtechconf.com/event/medica-2024/

NB

• ISS IVDR Notified Body – ISTITUTO SUPERIORE DI SANITA’: https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications/1010586?organizationVersion=3

ROW

Middle East

• Saudi Arabia: Labelling Guidance – What should contain a Medical Device Label in Saudi Arabia: https://www.sfda.gov.sa/sites/default/files/2024-10/MDS-014En.pdf

Northern America

• USA webinar on Registation & Listing Requirements – In-Vitro Diagnostics and Laboratory Developed Tests: https://www.fda.gov/medical-devices/cdrhnew-news-and-updates/webinar-registration-listing-requirements-in-vitro-diagnostic-products-ivds-including-laboratory
• USA Guidance on Dental products – Air Powered handpiece, Dental Cements, Dental Ceramics, Impressions:
  • Air powered: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/air-powered-dental-handpieces-and-air-motors-performance-criteria-safety-and-performance-based
  • Dental Cements: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dental-cements-performance-criteria-safety-and-performance-based-pathway
  • Dental Ceramics: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dental-ceramics-performance-criteria-safety-and-performance-based-pathway
  • Dental Impressions: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dental-impression-materials-performance-criteria-safety-and-performance-based-pathway
• Canada policy on Drug/device combinations – Who is who?: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/policies/policy-drug-medical-device-combination-products-decisions.html

South America:

• Brazil bans – Thermometers and Sphygmomanometers with a  Mercury column: https://antigo.anvisa.gov.br/documents/10181/6873945/RDC_922_2024_.pdf/1e09cbf1-53db-4609-bea7-34afb7ce633c

PODCAST

• Podcast Nostalgia – Last podcast to listen to-
  • Episode 302 – How to do PMCF literature Search for Medical Devices with Cesare Magri 4BetterDevices: https://podcast.easymedicaldevice.com/302-2/
  • Episode 303 – UK vs EU vs US – How to switch to another region easily? With Claire Dyson DQS : https://podcast.easymedicaldevice.com/303-2/
  • Episode 304 – How to select the best plastic for your Medical Device? Lucas Pianegonda Gradical: https://podcast.easymedicaldevice.com/305-2/

Social Media to follow

• Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
• Twitter: https://twitter.com/elazzouzim
• Pinterest: https://www.pinterest.com/easymedicaldevice
• Instagram: https://www.instagram.com/easymedicaldevice