IVD Monthly Newsletter

Dear reader,

The global regulatory landscape and performance standards continue to evolve. With the right tools and insights, this can be a powerful opportunity to gain or maintain a competitive edge. In this edition, we present essential insights and resources designed to support your regulatory strategy.

First, don’t miss our free webinar on December 5th, tailored to those facing the intricate requirements of clinical performance studies for in vitro diagnostics. Our panel of experts will share strategic regulatory and operational guidance to help you achieve successful outcomes.

We also cover the latest regulatory developments from the Medical Device Coordination Group (MDCG). MDCG 2024-11 is a very interesting read to understand what the Authorities think should be the criteria to be used to decide when a product can be defined as an IVD device or not and thus fall (or not) in the scope of the IVDR.?

Finally, we invite you to connect with our team at MEDICA 2024 in Düsseldorf this November. We look forward to discussing how QbD Group can support your organization’s journey through the complexities of IVD regulations and bring clarity to your compliance strategy.

I wish you a productive reading!

Maurizio Suppo | Vice President IVD - Regulatory Affairs

Let's connect on Linkedin

UPCOMING WEBINAR

Are you ready to enhance your IVD clinical performance strategy??

Are you facing challenges in demonstrating clinical performance for your in vitro diagnostics???

We are pleased to announce our upcoming free webinar on December 5th, featuring expert insights into the strategic, regulatory, and operational aspects of clinical performance studies.?Whether you are preparing for a new submission or seeking to refine your existing approach, this session is designed to provide actionable guidance to support your success.?

Register today

Get warmed up with our explainer videos!??

Would you like to know ‘Why Clinical Performance is key to a successful IVDR submission’? You’ll discover the answers in our first video and blog. Every week we discuss a different topic. Stay tuned for more!?

THE LATEST REGULATORY NEWS

• MDCG 2021-4 Revised MDCG Guidance on Class D IVD transitional provisions released. Read more
• MDCG 2024-12 New guidance and templates for the assessment CAPA plans. Read more
• MDCG 2024-11 New guidance on determining which products fall under the scope of the IVDR as in vitro diagnostic medical devices. Read more
• New Harmonized Standards Two new harmonized standards under IVDR and MDR published in the Official Journal of the European Union. Read more

SEE YOU AT THESE EVENTS?

Medica

11-14 Nov ?? | Düsseldorf, GE ??

In November, MEDICA will once again bring together international experts from the medical industry in Düsseldorf, Germany. QbD IVD | Qarad will be there too. We’d love to welcome you to our booth G92 at Hall 3.

Scilife Smart Quality Summit

14 Nov ?? | Virtual Event ??

Join the Smart Quality Summit of Scilife a conference designed to help you understand the evolving concept of quality and how to implement it in your operations.

Don't miss this chance to learn from the best and gain insights that can help you transform your approach to quality. Visit SciLife to register.

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GET IN TOUCH

Any questions or interested in one of our services? Don't hesitate to contact our colleague Jens, he is more than happy to assist you!