Medical Device News, July 2024 Regulatory Update

Medboard

EU

• Germany warns against overregulation of Medical Devices – Is it not too late: https://www.bundestag.de/presse/hib/kurzmeldungen-1006422
  • Title: MDR and IVDR next steps – Subtitle: Erik Vollebregt points: https://medicaldeviceslegal.com/2024/06/04/the-german-angle/
• MDCG 2022-13 Rev1 – Extension of the scope of designations: https://health.ec.europa.eu/document/download/27f91dc2-b5bc-44f9-a975-5024ce3ea556_en?filename=mdcg_2022-13_en.pdf
• MDCG 2024-10 Clinical Evaluation of orphan medical devices : For RARE DISEASES: https://health.ec.europa.eu/document/download/daa1fc59-9d2c-4e82-878e-d6fdf12ecd1a_en?filename=mdcg_2024-10_en.pdf
• Scheer – Brain Stimuilators -: Risks associated with Brain Stimulators: https://health.ec.europa.eu/consultations/scheer-call-external-experts-scheer-wg-risks-health-associated-use-brain-stimulators-not-having_en
• Fast access to Clinical Trial Information -: New CTIS: https://www.ema.europa.eu/en/news/faster-access-clinical-trial-information-europe
• AI Supervision required – AI ACT: https://www.autoriteitpersoonsgegevens.nl/en/current/ap-and-rdi-supervision-of-ai-systems-requires-collaboration-and-must-be-arranged-quickly

UK

• UK USA and Canada on AI – Guiding Principles: https://assets.publishing.service.gov.uk/media/66670b9be8d5f2d4bdfcbb37/transparency_ml-enabled_devices_guiding_principles.pdf

Swiss

• SWISSDAMED Actors Module – Open in August 6th, 2024: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/release-notes.html

MEDTECH CONF

• Medicall August 2nd 2024 – Chennai, India:  https://medtechconf.com/event/medicall-chennai-2024/
•  RAPS Convergence Sept 17-19 2024 –  Long Beach, California, USA: https://medtechconf.com/event/raps-convergence-2024/
• AI Act Summit October 1st 2024 – Strasbourg, France: https://medtechconf.com/event/ai-act-summit/

LIVE SESSION

• Medical Device Live Expert #1 – Replay: https://www.youtube.com/watch?v=RrzXj36Yrqc

• Medical Device Live Expert #2 – US is in the place: https://www.linkedin.com/events/medicaldeviceliveexpert-2-usais7214180765008359424/theater/

US

• Essential Drug Delivery Outputs for Devices Guidance – Learn FDA requirements for EDDOs: https://www.fda.gov/media/179545/download
• Recognized Standards – Change happens: https://www.govinfo.gov/content/pkg/FR-2024-06-24/pdf/2024-13777.pdf
• US Webinar IVD classification -: July 16th 1pm EST: https://www.fda.gov/medical-devices/medical-devices-news-and-events/webinar-in-vitro-diagnostic-product-ivd-classification-07162024
• Blog post – The promise of AI in Health Care – FDA knows: https://www.fda.gov/medical-devices/digital-health-center-excellence/blog-promise-artificial-intelligence-holds-improving-health-care

Australia

• Australia: Exempt Medical Device – They should still follow the rules: https://www.tga.gov.au/resources/resource/guidance/regulatory-obligation-exempt-medical-devices
• Cosmetics or therapeutics -TGA helps you to decide: https://www.tga.gov.au/sites/default/files/2024-06/cosmetics-therapeutic-goods-guidance-for-advertisers-suppliers.pdf
• : Essential Principle Checklist -Template available: https://www.tga.gov.au/resources/resource/checklists/essential-principles-checklist
• AusUDID is in the place – Australian UDI Database for sponsors and manufacturers: https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medical-device/unique-device-identification-udi-hub/udi-information-sponsors-and-manufacturers/australian-udi-database-sponsors-and-manufacturers

Saudi Arabia

• Extend Shelf Life – in case of Public emergency: https://tinyurl.com/EMDpod

Malaysia

• Workshop Post-Market Requirements – July 16th, 2024: https://www.autoriteitpersoonsgegevens.nl/en/current/ap-and-rdi-supervision-of-ai-systems-requires-collaboration-and-must-be-arranged-quickly
• Training: How to submit documents – July 17th, 2024: https://portal.mda.gov.my/index.php/doclink/program-8-hands-on-medcrest-post-market-pdf/eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWIiOiJwcm9ncmFtLTgtaGFuZHMtb24tbWVkY3Jlc3QtcG9zdC1tYXJrZXQtcGRmIiwiaWF0IjoxNzE4MjQ5OTgzLCJleHAiOjE3MTgzMzYzODN9._ZObFPlzSpQWnAoPKDxH_J8IWhmcTDNLsFpYe0AkO9M
• Are you satisfied with Malaysia MDA – You can rate here: https://www.mda.gov.my/index.php/news/1418-kajian-kepuasan-pelanggan-mda-1-2024

South Africa

• SAHPRA Medical Device Vigilance- Who to contact: https://www.sahpra.org.za/wp-content/uploads/2024/06/Contacts-for-Adverse-Events-Recalls-and-Market-Actions.pdf

PODCAST

• Episode 288 – Cleaning Validation – How to select the worst case (Heena Thakkar): https://podcast.easymedicaldevice.com/288-2/
• Episode 289 – AFNOR- How is a Notified Body designated: (Thomas Lommatzsch):  https://podcast.easymedicaldevice.com/289-2/
• Episode 290 – How to submit your AI/ML SAMD the right way? (Richie Christian): https://podcast.easymedicaldevice.com/290-2/

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