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Common Technical Issues of Active Medical Device 3

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Q: How to determine the servicelife of active medical devices? what factors should be considered?

A: The manufacturer should dynamically evaluate the service life of the product through risk analysis in the whole life cycle of the product. When there is no unacceptable risk within the service life of the product after listing, the expected service life determined before listing can be maintained; or the expected service life determined before listing can be extended after reassessment; when the safety and effective performance of the product after listing is reduced to the extent that the risk is unacceptable within the service life, the relevant responsible party (manufacturer and/or user) shall assess this risk and take corresponding measures.

      The following aspects should be considered in the determination of the service life of active medical devices: key components such as high integrity components, usage frequency and intensity transportation and storage, usage environment, cleaning, disinfection, sterilization, component maintenance and commervial factors, etc.

Q: What should be included in the research data or active medical devices' service life?

A: The adminstrative counterparts shall submit an anlysis and evaluation report on the service life of the product. The report shall specify the evaluation method, evaluation path, influencing factors and evaluation method, as well as the corresponding verification data. The verification data can be accelerated/real-time aging test data, empirical data, and other verification/validation data generated through reliability analysis method, simulation test method or other theoretical and simulation calculation methods.

Q: What is software core algorithm?

A: Software core algorithm refers to the algorithm neccessary to realise the software core function (the function neccessary for the software to complete the intended use in the intended environment), including but not limited to imaging algorithm, post-processing algorithm and artificial intelligence algorithm.

Even if there is no post-processing algorithm for medical images or data, if the device uses relevant software algorithms to achieve its intended clinical use (such as energy output control algorithm for theraputic devices), it is also considered into the scope of core algorithms.