PDA Midwest Chapter:  Quantitative Analysis of TÜV SÜD-issued Biocompatibility Deficiencies

On April 23, 2025, the PDA Midwest Chapter is pleased to have a dinner event with a technical presentation at the testing lab in New Brighton, MN to focus on TÜV SÜD-issued Biocompatibility Deficiencies.

Presentations:

Quantifying EU MDR Biocompatibility Deficiencies: Lessons Learned Presented by: Danny Oseid, Product Expert – Biocompatibility and Regulatory Strategy Coordinator at TÜV SÜD

Biological safety deficiencies in medical device submissions can lead to delays and significant financial burdens for manufacturers. This session examines a quantitative analysis of TÜV SÜD-issued biocompatibility deficiencies, focusing on key clauses from EU MDR 2017/745 and the ISbioO 10993 series. Supporting data from relevant classes of medical device submissions will be presented, highlighting common pitfalls and best practices for compliance.

This presentation will cover:

Common Biocompatibility Deficiencies – Insights from real-world medical device submissions, including product-specific deficiencies (e.g., gas-pathway and blood-contacting devices, but not limited to these). Regulatory Expectations & Best Practices – Interpretation of EU MDR 2017/745 and ISO 10993 requirements to reduce deficiencies. Streamlining Submissions – Introduction of newly updated biological safety checklists and filling guidance documents to improve the efficiency of MDR submissions. By leveraging these insights, manufacturers can enhance compliance strategies, mitigate deficiencies, and accelerate time to market.