Position paper Medical Device Lifetime

The Team-NB Position Paper defines the lifetime of medical devices under the Medical Devices Regulation 2017/745. It addresses the lack of a specific definition for 'device lifetime' in regulatory texts and provides guidelines for manufacturers to indicate device lifetime, including maintenance instructions. The paper discusses various guidance and standards, such as MDCG and EN ISO, highlighting the need for manufacturers to define an expected lifetime for devices and ensure their safety and effectiveness throughout this period. It also covers different device types, including implantable, active, software, and biological devices, and emphasizes the importance of post-market surveillance and clinical data in determining device lifetime. The paper concludes with recommendations for manufacturers on specifying device lifetime and ensuring compliance with safety and performance requirements.

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