Description: The EU Medical Device Regulation (2017/745) and IVD Regulation (2017/746) require the device manufacturer to take account of the generally acknowledged state of the art (e.g. in GSPR 1). It is cited in regulations but not defined; it is defined in standards and guidance but is interpreted differently. The understanding and implementation of that requirement is critical to the design and development of the device, the conformity assessment of the device and the post-market surveillance activities conducted by the manufacturer.
Learning Objectives:
learn how the draft standard ISO 18969 for clinical evaluations is approaching the subject of state of the art.
understand the regulatory requirement related to the state of the art.
appreciate the difference between ‘state of the art’ and ‘state-of-the-art’.
understand the importance of state of the art at different stages in the medical device lifecycle.
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