Global IVD Device Registration: IVDR – 2017/746 Challenges

The IVDR (In Vitro Diagnostic Regulation 2017/746) has drastically changed the regulatory landscape in Europe for IVD devices. The new regulations not only impose stricter risk classifications but also demand rigorous clinical evaluation and post-market surveillance.

What should you know about the IVDR?
💡 New risk classifications: Many devices that were previously considered low risk are now classified as higher risk, meaning the approval process will be more complex.
💡 Stricter clinical evaluation: Solid clinical evidence is now required not only for high-risk devices but also for those considered low-risk.
💡 Post-market surveillance: Once a device is on the market, the work doesn’t stop. Continuous monitoring is mandatory to ensure safety.

But that’s not all… While Europe implements the IVDR, other countries are also updating their own regulations. Complying with these global requirements can be a huge challenge for companies seeking to maintain their devices in international markets.

What are the most common mistakes?
One of the most frequent is underestimating the clinical requirements and new risk classifications. Many companies aren’t fully prepared for these changes, which can delay the market entry of their products.

💬 Are you ready to face these challenges?
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