Regulatory Affairs & Life Science

In this episode, we explore the essentials of medical device registration under Italian law and the EU Medical Device Regulation (MDR 2017/745). We cover everything you need to know about the Italian medical device database, the Repertorio, the CND classification system, and the future role of EUDAMED. 🔑 Keywords & Topics:

• Medical device registration process
• Italian Ministry of Health requirements
• EU MDR compliance
• CND code and Repertorio explained
• EUDAMED implementation timeline
• Regulatory strategy for manufacturers and distributors

👩‍⚕️ Whether you’re a manufacturer, authorized representative, importer, distributor, PRRC or RAQA professional, this episode will help you avoid mistakes and stay compliant with the latest medical device regulations. 👉 Listen now and stay updated on regulatory affairs for medical devices.

#MedicalDevices #RegulatoryAffairs #MDR745 #EUDAMED #MedicalDeviceCompliance #HealthcareRegulation #RAQA #PRRC

In this episode, we examine the most frequent mistakes made by companies and economic operators during the registration of medical devices.

From selecting the correct UDI code to properly designating the economic operator, we provide a clear and practical overview of the key issues to avoid in order to ensure a compliant and effective registration process.

A valuable episode for industry professionals looking to approach European regulations with greater confidence.

Welcome to a new episode of the Di Renzo Regulatory Affairs podcast, where we explore key topics from the world of pharmaceutical regulatory affairs — with clarity, professionalism, and a practical approach.

Today, we’re focusing on a crucial subject for all Marketing Authorisation Holders: Local Pharmacovigilance.

It’s a vital system to ensure patient safety and regulatory compliance — often underestimated, but absolutely essential across the European landscape.

What does it take to set up an effective local pharmacovigilance network? What are the specific responsibilities of Marketing Authorisation Holders?

And how can an experienced partner like Di Renzo Regulatory Affairs support companies in managing these obligations?

We’ll cover all of this in today’s episode — clarifying roles, regulatory requirements, and practical solutions in the field of local pharmacovigilance. Stay with us!

In this episode of the Di Renzo Regulatory Affairs Podcast, we explore a question at the heart of digital health compliance: When does your software become a medical device? Drawing from our latest article “How to understand if the software is a medical device?” we dissect the critical concept of intended medical purpose—diagnosis, prevention, monitoring, or treatment—and how it transforms standalone software into a regulated medical device.

If you're developing health-focused software—whether it's tracking patient metrics, analyzing data, or offering diagnostic support—this episode guides you through the essential criteria: does your tool carry an intended medical use? If yes, you need to treat it as a medical device: from EU MDR classification to validation and regulatory obligations.

By the end, you'll confidently answer: “Is our software a medical device?”, and know the steps to bring it to market.

Join us in this episode as we delve into the complex world of medicinal product labelling—a cornerstone of patient safety and regulatory compliance. We’ll explore:

• Evolving EU requirements: product names, active substances, strengths, and routes of administration;
• The impact of 2D QR codes and Braille: innovations for inclusive and accessible communication;
• The regulatory evolution of multilingual labelling: how to manage multi-language content while maintaining clarity and compliance;
• Operational challenges and practical solutions: from label design to approval, with a focus on version control and content consistency.

This episode is tailored for regulatory affairs, quality, and packaging professionals. Expect real-life examples, best practices, and key insights to navigate complexity efficiently—reducing risk and speeding up time to market.

Why listen:

• Stay up to date with evolving regulations and global trends.
• Gain actionable strategies to streamline internal processes—from creation to approval.
• Strengthen product quality and safety, a key differentiator in a competitive market.

Get ready to decode medicinal labelling like never before: where technology, regulation, and accessibility come together to ensure that every patient receives the right information, the right way.

🎙️ New episode of the Di Renzo Regulatory Affairs podcast! Today we’re diving into a topic that is often underestimated but absolutely essential in the cosmetics sector: labeling. 📦 What does a label need to include to be considered compliant?

🧴 Which pieces of information are mandatory, and what mistakes should be avoided at all costs?

In this episode, our experts walk you through the 7 key rules for correctly labeling a cosmetic product under Regulation (EC) No. 1223/2009. It’s a must-listen guide for companies, industry professionals, and anyone working in the cosmetics field.

🔍 From identifying the Responsible Person, to correctly using INCI nomenclature, to including proper environmental and safety indications — each point will help you navigate regulatory requirements with confidence.

🎧 Tune in to discover how labeling can become a powerful tool for compliance, transparency, and consumer trust.

📍 Available on Spotify, Apple Podcasts, and all major platforms.

In this episode, we explore the crucial role of statistical analysis in the post-market surveillance of medical devices.

We discuss how the collection and interpretation of data help ensure the safety and effectiveness of devices once they enter the market.

We delve into the statistical methodologies used, common challenges, and best practices for effective monitoring in compliance with European regulations.

Welcome to a new episode of our podcast dedicated to the world of pharmaceutical regulatory affairs.
Today, we’ll take a journey through time to explore the regulatory history of food supplements, a constantly evolving sector that is becoming increasingly relevant for both the industry and consumers.

Starting from the 1980s up to the current European regulatory framework, we'll examine how the very concept of a “supplement” has developed, the key milestones in the legislative path, and the main regulatory challenges faced today.

The episode is based on an article published by Di Renzo Regulatory Affairs, which you can find on their website — but here, we’ll walk you through the key points, with insights and reflections for professionals in the field or anyone curious to learn more. Would you like me to translate the teaser for social media as well?

🎙️ New Podcast Episode: Navigating the Transition from PMCs to Biocides In our latest episode, we delve into the evolving regulatory landscape surrounding Presidi Medico Chirurgici (PMCs) and their transition to biocidal products within the European Union. This shift, driven by Directive 98/8/EC, aims to harmonize standards across member states, ensuring enhanced safety and efficacy of products such as disinfectants, insecticides, and repellents.

The directive introduces a comprehensive evaluation of active substances, categorizing biocidal products into 23 distinct types and necessitating rigorous assessments, including toxicological and ecotoxicological studies. This transformation presents significant challenges for companies, especially those navigating the complexities of dossier preparation and compliance during the transitional phase

Di Renzo Regulatory Affairs offers expert guidance to companies, assisting in feasibility studies, regulatory intelligence, and the preparation of comprehensive dossiers to facilitate a smooth transition from PMCs to biocides.

Tune in to gain valuable insights into adapting to these regulatory changes and ensuring your products meet the new European standards. 🔗 Read the full article

Welcome to a new episode of Regulatory Affairs & Life Science, your go-to space for deep dives into the pharmaceutical world—where regulations, innovation, and public health protection meet. Today, we’re tackling a crucial and complex topic: responsibility in pharmacovigilance.

Who is truly accountable for the safety of medicines once they’re on the market? What are the roles of pharmaceutical companies, Qualified Persons for Pharmacovigilance (QPPVs), and regulatory authorities?

Starting from an insightful analysis by Di Renzo Regulatory Affairs, we’ll explore how the concept of responsibility in pharmacovigilance has evolved—from European regulations to the practical implications for companies in the field.

This is a must-listen episode for anyone working in regulatory affairs or anyone curious about how the safety of the medicines we use every day is monitored and ensured.

Stay with us…