MEDICAL DEVICE NEWS – SEPTEMBER 2023 Regulatory Update

EU

o 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 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

o 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:

o 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

o 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:

o 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:

o Off-the-Shelf Software :https://www.fda.gov/media/71794/downloadSaudi Arabia:

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

eQMS:

o SmartEye : https://smart-eye.io

Conferences

o 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/