Medical Device News, July 2024 Regulatory Update

Medboard EU UK Swiss MEDTECH CONF LIVE SESSION US Australia Saudi Arabia Malaysia South Africa PODCAST Social Media to follow

The post Medical Device News, July 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

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/

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

The post Medical Device News, July 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir