MEDICAL DEVICE NEWS – SEPTEMBER 2023 Regulatory Update

EU

• MDR and IVDR communication Survey: https://ec.europa.eu/eusurvey/runner/MDR_and_IVDR_Communication_Survey
• EU MDR transition
  • Q&A implementation of MDR extension 2023/607: https://health.ec.europa.eu/system/files/2023-07/mdr_proposal_extension-q-n-a.pdf
  • Flowchart to a decision on the extended MDR transitional period: https://health.ec.europa.eu/document/download/2d29bd99-8523-4c13-bbf5-cc36fcecea93_en?filename=md_devices-art120_flowchart.pdf
  • Team-NB: New MDR Transition Timeline and Notified Body Capacity: https://www.team-nb.org/wp-content/uploads/2023/08/Team-NB-PositionPaper-MDRTransitionTimelines-NotifiedBodyCapacity-V1.pdf
  • Blog Post – Erik Vollebregt . Can we fix/improve the MDR and the IVDR? https://medicaldeviceslegal.com/2023/08/29/can-we-fix-improve-the-mdr-and-the-ivdr/
• Team-NB: Transfer agreement:https://www.team-nb.org/wp-content/uploads/2023/08/Team-NB-PositionPaper-TransferAgreement-V1-20230811.pdf
• Notified Bodies situation :https://health.ec.europa.eu/document/download/3d407427-fad0-498a-b1ef-2db28c9f4423_en?filename=notifiedbodies_overview_en.pdf
• EMA consultation: https://www.ema.europa.eu/en/documents/other/questions-answers-consultation-procedure-european-medicines-agency-notified-bodies-ancillary_en.pdf

Training offered:

• Vigilance Reporting: https://school.easymedicaldevice.com/course/vigilance-reporting-eu-legislation/
• Audit readiness: https://school.easymedicaldevice.com/course/etraining-audit-readiness/
• Green Belt: https://school.easymedicaldevice.com/course/gb26/

UK:

• CE Marking recognition: https://www.gov.uk/government/news/ce-marking-recognition-for-medical-devices-and-in-vitro-diagnostics?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=70128116-5d7a-4e60-89d6-99e578f8a33b&utm_content=immediately
  • Ronald Boumans article: https://www.linkedin.com/posts/ronald-boumans_ukca-maring-for-medical-devices-and-ivds-activity-7092405961541185536-bfRY?utm_source=share&utm_medium=member_desktop
  • Guardian article: https://www.theguardian.com/commentisfree/2023/aug/04/business-brexit-safety-mark-red-tape-?mibextid=Zxz2cZ
  • Guardian article: https://www.theguardian.com/politics/2023/aug/08/left-in-limbo-by-brexit-safety-mark-chaos?mibextid=Zxz2cZ 
• 3 new UK Approved bodies :https://www.gov.uk/government/news/three-new-uk-approved-bodies-to-certify-medical-devices-announced-by-the-mhra
  • Approved Body list: https://www.gov.uk/government/publications/medical-devices-uk-approved-bodies

TGA:

• Webinar :
  • The new Medical devices Vigilance Program- Information for medical device Sponsors in Australia: https://www.tga.gov.au/resources/event/webinars/new-medical-devices-vigilance-program-information-session-medical-device-sponsors-australia
  • UDI: https://www.tga.gov.au/resources/event/webinars/unique-device-identification-webinar-18-project-checkpoint-what-we-know-and-what-you-can-do-get-involved

Canada:

• Pre-market guidance for Machine learning-enabled : https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/pre-market-guidance-machine-learning-enabled-medical-devices.html

USA:

• Off-the-Shelf Software :https://www.fda.gov/media/71794/download

Saudi Arabia:

• ISO 13485 for manufacturers & supplies facilities : https://www.sfda.gov.sa/sites/default/files/2023-08/MD-Quality13485.pdf

eQMS:

• SmartEye : https://smart-eye.io

Conferences

• MEDXD – Berlin Germany September 26 and 27- https://medtechx.digital/
• Afrisummit – Cairo Egypt https://www.pharmaregafrisummit.com/meddev/
• MEDICA – Dusseldorf Germany https://www.medica-tradefair.com/
• Team-PRRC – Strasbourg France https://www.team-prrc.eu/page/1111392-presentation

Podcast to listen

• Medical Misfits episode: How to join a Tech Startup as a Medical Student: https://www.medicalmisfits.com/zoe-lee/
• The Medtech Podcast by Karandeep Badwal: https://open.spotify.com/show/32CvtseLj3KknqYDFdO7P3
• The Med-Tech Talent Lab with Mitch Robbins: https://open.spotify.com/show/4b6r5OPbgsS6DqhCZuAFG2
• Life Science 360 with Harsh Thakkar: https://www.lifesciencespod.com/2079900
• State of Medtech with Omar Khateeb: https://open.spotify.com/show/5NVrQLfLk0EXDeKDdX7BB6

Podcast Nostalgia

• Who should be on your Risk Management Dream Team with Naveen Agarwal:  https://podcast.easymedicaldevice.com/243-2/
• Hire your QA RA employee with no Budget with Mitch Robbins: https://podcast.easymedicaldevice.com/244-2/
• Why you should automate your Software Validation with Christophe Girardey and Virginie Rochat? https://podcast.easymedicaldevice.com/245-2/
• What are the Acceptance Criteria for your Clinical Evaluation with Cesare Magri. https://podcast.easymedicaldevice.com/246-2/
• How to perform your Cleaning Validation in practice? With Enrico Allegra: https://podcast.easymedicaldevice.com/247-2/