Reg with MEG cover art

Reg with MEG

Reg with MEG

By: MedEnvoy Global
Listen for free

Reg with MEG brings together industry experts to explore the ever-changing world of global medical device compliance. From EU MDR/IVDR and FDA pathways to regulatory importer obligations, Post Market Surveillance (PMS), and market access, we break down complex regulatory topics into clear, actionable conversations.MedEnvoy Global Economics
Episodes
  • EU REP Symbol Replaces EC REP Symbol for Medical Device Labeling

    EU REP Symbol Replaces EC REP Symbol for Medical Device Labeling
    Jun 24 2026

    The European Commission has officially confirmed the transition from the EC Rep symbol to EU Rep symbol on medical device labeling. In this episode, we break down the new MDCG guidance, key compliance deadlines, labeling requirements, and what the change means for MDR and IVDR manufacturers. Learn how to update your labeling strategy, manage existing inventory, and prepare for the transition without disrupting market access.

    Note: This episode was created and hosted by AI

    #eurep #ecrep #medicaldevicelabeling #mdr #ivdr
    Show More Show Less
    10 mins
  • Regulatory News Recap | FDA, TGA & Swissmedic Regulatory Updates

    Regulatory News Recap | FDA, TGA & Swissmedic Regulatory Updates
    May 29 2026

    In this episode, we break down three major global updates impacting medical device and digital health manufacturers: the FDA’s reclassification of skin cancer diagnostic devices, Australia’s new guidance on digital mental health software, and Swissmedic’s 2026 post-market surveillance campaign for higher-risk devices.Note: This episode was created and hosted with AI.
    Show More Show Less
    13 mins
  • RAPS Euro Convergence 2026 Takeaways with Dean Adair

    RAPS Euro Convergence 2026 Takeaways with Dean Adair
    May 28 2026

    In this episode, MedEnvoy's Regulatory Affairs Consultant Dean Adair shares key takeaways from this year's RAPS Euro Convergence in Lisbon, Portugal, including the MDR/IVDR 2.0, the growing role of AI in medical device regulation, and the biggest compliance concerns manufacturers are facing across Europe.

    #rapseuroconvergence #mdr2.0 #ivdr2.0 #aimedicaldevice
    Show More Show Less
    21 mins
adbl_web_anon_alc_button_suppression_t1
No reviews yet