PRIME MEMBER EXCLUSIVE | 3 Months Free Trial

Auto-renews at INR 199/mo after 3 months. Cancel anytime. Offer ends 15 July, 2026.
Regulatory Affairs & Life Science cover art

Regulatory Affairs & Life Science

Regulatory Affairs & Life Science

Written by: Di Renzo Regulatrory Affairs
Listen for free

The Di Renzo Regulatory Affairs podcast for pharmaceutical companies, for manufacturers of medical devices, cosmetics, food supplements and disinfectants. News from our blog and from our weekly magazine ISI, Information Health.Di Renzo Regulatrory Affairs Economics Leadership Management & Leadership
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
    Show More Show Less
    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.
    Show More Show Less
    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!
    Show More Show Less
    7 mins
adbl_web_anon_alc_button_suppression_t1
No reviews yet