MEDICAL DEVICE NEWS – SEPTEMBER 2023 Regulatory Update

This month we will review all what happened in the Medical Device world during the last weeks and what will happen in the next weeks. Check that

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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/

The post MEDICAL DEVICE NEWS – SEPTEMBER 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir