Medical Device Lifetime Overview

Purpose: Team-NB addresses the lack of a clear definition for "medical device lifetime" in EU MDR regulations.

Key Points:

·         Manufacturers must specify a device's operational lifetime, ensuring ongoing safety and performance.

·         Device lifetime definitions vary across types, requiring tailored assessments and maintenance plans.

Action Items:

·         Clearly define device lifetime in documentation and instructions, based on rigorous testing and risk management.

·         Use clinical and post-market data to validate the device's safety and effectiveness throughout its lifespan.

Conclusion: Defining and maintaining medical device lifetime is essential for regulatory compliance and ensuring patient safety.

🔗 Original:   https://www.team-nb.org/wp-content/uploads/2023/12/Team-NB-PositionPaper-Lifetime-Medical-Device-20231127-1.pdf