On July 29th, 2025, MedTech Europe published a position paper advocating for a more proportionate, risk-based approach to sampling under the IVDR.
đź“Ś Key proposals include:
• Targeting sampling efforts on high-risk and novel devices
• Allowing flexibility in applying statistical methodologies
• Promoting cooperation between industry and authorities to define realistic criteria
The current one-size-fits-all approach to sampling is seen as impractical, particularly for SMEs, and may delay patient access to critical diagnostics.
👉 At Instituto Pedro Nunes (IPN), we guide IVD companies through IVDR implementation with tailored strategies that reflect real-world risks and resources.
đź”— Read the full position paper (EN)