Medical Device News, July 2024 Regulatory Update

July 2024 Regulatory Update
Medboard
EU
• Germany warns against overregulation of Medical Devices - Is it not too late: www.bundestag.de/presse/hib/k...
o Title: MDR and IVDR next steps - Subtitle: Erik Vollebregt points: medicaldeviceslegal.com/2024/...
• MDCG 2022-13 Rev1 - Extension of the scope of designations: health.ec.europa.eu/document/...
• MDCG 2024-10 Clinical Evaluation of orphan medical devices : For RARE DISEASES: health.ec.europa.eu/document/...
• Scheer - Brain Stimuilators -: Risks associated with Brain Stimulators: health.ec.europa.eu/consultat...
• Fast access to Clinical Trial Information -: New CTIS: www.ema.europa.eu/en/news/fas...
• AI Supervision required - AI ACT: www.autoriteitpersoonsgegeven...
UK
• UK USA and Canada on AI - Guiding Principles: assets.publishing.service.gov...
Swiss
• SWISSDAMED Actors Module - Open in August 6th, 2024: www.swissmedic.ch/swissmedic/...
MEDTECH CONF
• Medicall August 2nd 2024 - Chennai, India: medtechconf.com/event/medical...
• RAPS Convergence Sept 17-19 2024 - Long Beach, California, USA: medtechconf.com/event/raps-co...
• AI Act Summit October 1st 2024 - Strasbourg, France: medtechconf.com/event/ai-act-...
LIVE SESSION
• Medical Device Live Expert #1 - Replay: • Medical Device Live Ex...
• Medical Device Live Expert #2 - US is in the place: / theater
US
• Essential Drug Delivery Outputs for Devices Guidance - Learn FDA requirements for EDDOs: www.fda.gov/media/179545/down...
• Recognized Standards - Change happens: www.govinfo.gov/content/pkg/F...
• US Webinar IVD classification -: July 16th 1pm EST: www.fda.gov/medical-devices/m...
• Blog post - The promise of AI in Health Care - FDA knows: www.fda.gov/medical-devices/d...
Australia
• Australia: Exempt Medical Device - They should still follow the rules: www.tga.gov.au/resources/reso...
• Cosmetics or therapeutics -TGA helps you to decide: www.tga.gov.au/sites/default/...
• : Essential Principle Checklist -Template available: www.tga.gov.au/resources/reso...
• AusUDID is in the place - Australian UDI Database for sponsors and manufacturers: www.tga.gov.au/how-we-regulat...
Saudi Arabia
• Extend Shelf Life - in case of Public emergency: tinyurl.com/EMDpod
Malaysia
• Workshop Post-Market Requirements - July 16th, 2024: www.autoriteitpersoonsgegeven...
• Training: How to submit documents - July 17th, 2024: portal.mda.gov.my/index.php/d...
• Are you satisfied with Malaysia MDA - You can rate here: www.mda.gov.my/index.php/news...
South Africa
• SAHPRA Medical Device Vigilance- Who to contact: www.sahpra.org.za/wp-content/...

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