Episodes

  • MDR Turning Point: What Changes with the Proposed Revision of the Medical Device Regulation?

    MDR Turning Point: What Changes with the Proposed Revision of the Medical Device Regulation?
    Jul 14 2026
    A few years after the entry into force of Regulation (EU) 2017/745 (MDR), the European Commission is taking action to make the system more sustainable. With the amendment proposal COM(2025)1023, Europe aims to cut red tape and boost the competitiveness of the medical sector—without compromising the strict safety standards of medical devices.In this podcast episode, we analyze the impact of this upcoming revision on manufacturers and industry operators.What we discuss in this episode:
    • Process Digitalization: How the transition to electronic documentation and digital workflows (linked to EUDAMED) will reduce the paperwork burden.
    • Flexibility for the PRRC: New opportunities for regulatory outsourcing—a breath of fresh air, especially for SMEs.
    • Streamlining vs. Safety: What is changing on the administrative front and why clinical evaluation and post-market surveillance requirements remain as strict and unchanged as ever.
    • Ongoing Challenges: The limited capacity of Notified Bodies and the structural bottlenecks that have yet to be resolved.
    🎧 Tune in to find out how to guide your business through this regulatory evolution!📌 To delve deeper into the topic, read our full blog post: Revision of Regulation (EU) 2017/745 (MDR): Impact on Manufacturers
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    9 mins
  • EUDAMED and UDI Codes: A Practical Guide to Getting It Right

    EUDAMED and UDI Codes: A Practical Guide to Getting It Right
    Jul 3 2026
    As deadlines approach and new European obligations take effect, the proper management of medical devices requires unprecedented attention. In this episode, we clear up everything you need to know to successfully navigate EUDAMED registration (registrazione eudamed) without running into compliance roadblocks.We will break down the system's operational phases, explaining how to structure your data and correctly assign the UDI code (codice udi)—from the Basic UDI-DI all the way down to individual commercial packaging—to ensure full traceability and compliance with MDR and IVDR regulations. Whether you are a manufacturer, authorized representative, or importer, discover practical tips and essential steps to optimize your company's workflow and avoid bureaucratic delays.Happy listening!Listen to the episode and leave a comment with your regulatory questions.
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    9 mins
  • Importers and Distributors: When Do Manufacturers' Obligations Start? (MDR/IVDR)

    Importers and Distributors: When Do Manufacturers' Obligations Start? (MDR/IVDR)
    May 25 2026
    When does a distributor or importer become, for all legal purposes, the MANUFACTURER of a medical device?
    In this episode, we shed light on one of the most complex, sensitive, and controversial aspects of the European Regulation on Medical Devices (MDR 2017/745) and the European Regulation on In Vitro Diagnostics (IVDR 2017/746): Article 16.
    If you work in logistics, distribution, import, or compliance in the MedTech sector, you can't miss this episode.

    Let's analyze together:

    👉 The 3 key scenarios in which the automatic change of legal role is triggered.
    👉 The key exceptions (when label translation and repackaging do not alter your qualifications).
    👉 The strict additional obligations for those who repackage (28-day advance notification and Quality Management System Certification).

    Avoiding sanctions or customs blockades on the market requires a thorough understanding of your economic roles. Listen to the episode to find out how to protect your business!

    Enjoy!
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    7 mins
  • The importance of GMP audits for the production of "Human" and "Vet" pharmaceuticals

    The importance of GMP audits for the production of "Human" and "Vet" pharmaceuticals
    May 22 2026
    What happens before a drug reaches our hands or those of our animals? In this episode, we explore the beating heart of safety and compliance: GMP (Good Manufacturing Practice) audits in the pharmaceutical industry.
    Together with industry professionals, we analyze why these inspections aren't just bureaucratic procedures, but rather true safeguards for public health and business stability. We'll discover the concrete benefits for companies (and marketing authorization holders), what auditors really look for when they enter a manufacturing facility, and why—after the pandemic—on-site inspections have once again become an indispensable requirement compared to remote digital controls.
    If you work in the regulatory or quality sectors, or simply want to understand the rigorous standards behind the production of a human or veterinary medicinal product, this is the episode for you!
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    7 mins
  • Drug Shortages: What changes for MAH holders? 💊

    Drug Shortages: What changes for MAH holders? 💊
    Mar 20 2026
    Managing shortages is more than just a logistical challenge; it is a complex web of regulatory obligations. In this episode, we analyze the latest AIFA (Italian Medicines Agency) provisions and the specific responsibilities of Marketing Authorization Holders (MAH).In this episode, we dive into:
    • Mandatory communication timelines and procedures.
    • Penalties for failure to notify.
    • Operational strategies to prevent disruptions in patient care.
    Essential listening for Regulatory Affairs and Quality Assurance professionals.
    🎧 Listen to the episode now to stay compliant and informed!
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    9 mins
  • AIFA guidelines for SOP and OTC

    AIFA guidelines for SOP and OTC
    Mar 6 2026
    Managing SOP (Non-Prescription Medicines) and OTC (Over-the-Counter) drugs requires surgical attention to regulatory details. In this episode, we explore the key points of the AIFA guidelines:
    ✅ Medicine classification.
    ✅ Requirements for online sales.
    ✅ Sticker layouts and mandatory labeling.An essential episode for Regulatory Affairs Managers and industry consultants. Enjoy the listen!
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    9 mins
  • Packaging & Compliance: Why Design Alone Isn’t Enough

    Packaging & Compliance: Why Design Alone Isn’t Enough
    Feb 6 2026
    In the Pharma and Healthcare sectors, a graphic error is more than just an aesthetic flaw—it’s a significant legal risk. In this episode, we analyze why the design of pharmaceuticals, supplements, and medical devices must go hand-in-hand with Regulatory Affairs.Join our experts as we explore:
    • Pharmaceutical Sector: Managing artwork and the surgical precision required for patient information leaflets (PILs).
    • Dietary Supplements: How to communicate benefits (claims) without violating government regulations.
    • Medical Devices & Cosmetics: From CE marking to the correct management of INCI lists.
    • Advertising: The strategic advantage of creating healthcare advertising that is "compliant by design" to avoid penalties and speed up time-to-market.
    Learn how to transform regulatory constraints into a competitive advantage for your brand. If you work in marketing, quality assurance, or regulatory affairs, this episode is for you.📌 Want to dive deeper? Visit our website to read the full article and discover our compliant packaging design services.
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    5 mins
  • The New Face of Veterinary GMPs

    The New Face of Veterinary GMPs
    Feb 2 2026
    The veterinary medicinal products sector is undergoing an unprecedented regulatory transformation. In this episode, we analyze the adaptation to the new veterinary GMPs (Good Manufacturing Practices) introduced by Regulation (EU) 2019/6 and subsequent directives.We explore the key points from the article by Di Renzo Regulatory Affairs, focusing on:
    • The primary differences compared to standards for medicinal products for human use.
    • Requirements for manufacturing, importation, and pharmacovigilance.
    • Critical deadlines and the importance of a risk-based approach.
    Essential listening for Quality Managers, industry professionals, and companies operating within the animal health market.
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    6 mins