This episode of MedTech Global Insights provides a deep dive into the General Safety and Performance Requirements (GSPR) of the EU MDR 2017/745, Annex I. We move beyond the checklist and explore the real-world challenges and regulatory expectations associated with these critical requirements.

We uncover the most common pitfalls that can lead to Notified Body rejections, from inadequate justifications to insufficient clinical evidence. Learn how to build a GSPR compliance strategy that is robust, evidence-based, and aligned with the highest standards of safety and performance for your medical device.

A specific example we explore involves a company with an innovative AI-powered diagnostic software. Despite having strong data on technical accuracy, their submission was challenged because their clinical evaluation failed to prove a tangible benefit to patient outcomes, a key demand of GSPR 1 and 8. This misstep resulted in costly delays and the need for a new prospective clinical study, a pain point that could have been avoided with a more robust regulatory strategy.

Key Takeaways:

- Why is simply marking a GSPR as "Not Applicable" a major red flag for auditors?

- How can you definitively prove clinical benefit beyond just technical performance data?

- What specific evidence is required to justify the chemical and biological safety of your materials?

- Have you fully assessed the risks associated with your device's user interface and labeling?

- Is your risk management file a truly living document that aligns with all GSPRs?

- How do you bridge the gap between the old Essential Requirements and the more demanding GSPRs?

- What are the most common weaknesses found in technical documentation related to GSPR Chapter II on design and manufacturing?

- Are your post-market surveillance activities adequately designed to confirm ongoing GSPR compliance?

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