The MDCG 2024-11 guidance offers essential clarity for manufacturers and stakeholders navigating the qualification of in vitro diagnostic medical devices (IVDs) under the IVDR (EU) 2017/746. Whether you’re new to IVD manufacturing or adjusting to the updated IVDR requirements, this guidance is a key resource. Here’s what you need to know about the specifics of IVD qualification, and how BSP Ltd. can assist you in achieving compliance.

Understanding IVD Qualification: Key Insights from MDCG 2024-11

The guidance is designed to address the nuanced aspects of IVD qualification, clarifying product definitions and regulatory boundaries:

1. Core IVD Characteristics: IVDs encompass a wide range of products—including reagents, diagnostic kits, software, and instruments—designed for in vitro use to analyse human samples such as blood or tissue. The primary function must be medical, such as diagnosing diseases, screening for genetic predispositions, or monitoring treatments. Importantly, non-medical tests (like wellness or ancestry tests) are outside this scope unless they serve a medical purpose​

2. Special Product Types: The guidance details classification for specific products:

   • Accessories: Products essential to an IVD’s function, such as calibration materials, are included under IVDR. However, invasive tools for specimen collection, such as needles, are covered under MDR as they interact directly with the human body​.

     Sample Collection Devices: Non-invasive devices, like blood collection tubes, are considered IVDs if designed for sample transport and preservation. Direct-contact devices like scalpels fall under MDR.

   • Software: Software that interprets or analyzes diagnostic data is classified as an IVD, even if it doesn’t directly handle samples. This applies to AI-driven tools and machine learning models that support clinical decisions, reflecting advancements in digital diagnostics​.

3. Exemptions and Clarifications:

   • Research-Only Products (RUO): Products labeled as RUO are exempt unless intended for diagnostic use.

   • Laboratory Equipment: Common lab tools like pipettes aren’t considered IVDs unless uniquely purposed for diagnostics.

   • Production Testing: Tests used solely in industrial or pharmaceutical production do not qualify as IVDs unless they are designed for direct diagnostic purposes​

How BSP Ltd. Can Help

At BSP Ltd., we specialise in guiding clients through the complexities of EU medical device regulations, including IVDR compliance. With MDCG 2024-11, understanding your product’s precise classification under the updated guidelines is crucial to avoid regulatory pitfalls.

To assist you, BSP Ltd. offers a free initial consultation where we’ll assess your needs, advise on the specifics of IVD classification, and outline a regulatory strategy that ensures compliance. Whether you need help with documentation, regulatory submissions, or strategic planning, our expertise in EU IVD and medical device regulations is here to support your business every step of the way.

Contact BSP Ltd. to learn more about how we can help you seamlessly navigate these new requirements, reducing risk and positioning your business for success in the evolving EU market.