European Biomedical Institute

28/08/2025

🌎 For manufacturers selling internationally, navigating FDA and MDR biocompatibility requirements is a major challenge.

EU MDR follows ISO 10993-1’s risk-based framework, emphasizing chemical characterization and justifying the testing approach. The FDA often requests more in vivo data and has specific guidance on toxicity endpoints, such as systemic toxicity and sensitization.

Understanding the differences is key:

👉 Where do standards converge and diverge?
👉 How to leverage chemical characterization and extractables & leachables data to minimize animal testing and satisfy both agencies?
👉 What are the documentation differences, particularly for Biological Evaluation Reports?

EBI guides manufacturers through these nuances, helping build integrated strategies that anticipate and address regulatory questions proactively.

🚀 Selling across both markets? Let’s discuss a strategic approach bridging these regulatory frameworks.

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11/07/2025

🔬 Why a Risk-Based Approach to Biocompatibility Saves You Time and Money

Is more testing always better? Not when it comes to biocompatibility.
A risk-based approach — as recommended by ISO 10993-1 and MDR — helps manufacturers avoid unnecessary testing, focus resources where risks actually exist, and streamline regulatory submissions.

In our latest article, we explain:
💡 How to build a risk-based biocompatibility strategy
💡 Why chemical characterization is key
💡 How this approach leads to faster market approvals

Learn why smart planning is more powerful than excessive testing.

👉 Read the full article here:

https://ebi.bio/why-a-risk-based-approach-to-biocompatibility-saves-you-time-and-money/

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19/05/2025

What Is a Biological Evaluation Plan (BEP)? | Biocompatibility Testing Explained ?

Curious about how medical devices are evaluated for safety? In just 90 seconds, Wiola breaks down the Biological Evaluation Plan (BEP)—a key part of biocompatibility testing required for MDR and FDA compliance.

Learn:
✅ What a BEP is
✅ Why it evolves with your device
✅ The 6 essential components of every BEP

Whether you're in Regulatory Affairs, Quality Assurance, or Medical Device Development, this quick guide is for you!



https://www.youtube.com/shorts/ZWtCvqfkAGs

Send a message to learn more

13/05/2025

🇧🇪 EBI is heading to Regulatory Affairs Professionals Society (RAPS) Euro Convergence 2025 in Brussels on May 13–16

We’re excited to join one of Europe’s leading regulatory affairs events—bringing together experts, authorities, and innovators to discuss MDR/IVDR, global regulations, and the future of patient-focused healthcare.

Our team—Anna Kuźma and Iwona Pobidyńska—will be there and ready to connect with medical device manufacturers and regulatory professionals.

💬 Attending too? Let’s meet in Brussels!

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23/04/2025

🚀 Time and Cost of Biocompatibility Testing: How to Plan Your Project Budget | https://lnkd.in/dZ_Mnyav

Effective planning for biocompatibility testing is essential for medical device manufacturers looking to stay on track with both compliance and budget. With a clear understanding of regulations like MDR and ISO 10993, you can strategically navigate the testing process while avoiding unnecessary expenses and delays.

👉 Explore how to optimize your biocompatibility testing strategy in our latest blog: https://lnkd.in/dZ_Mnyav

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