Whitepaper: State of the Art in the context of the new Medical Device Regulations

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In this paper we will discuss the challenges a CER author will have to overcome while building up a SoTA section, as well as resources and practical solutions/best practices to facilitate its preparation.

The clinical evaluation report (CER) heavily relies on the State of the Art (SotA) discussion to identify whether

  • the medical and/or in-vitro diagnostic medical device achieves its intended purpose without exposing users and patients to unidentified risks and
  • the benefit/risk ratio for the medical device is acceptable when weighed against the benefits to the patient.

Nevertheless, there is no consensus on what State of the Art is or what it should discuss.

The purpose of this paper is to discuss such challenges, identify their potential sources and propose solutions and/or some best practices that a CER author may implement in his/her everyday practice. Moreover, this paper intents to provide some best practices for SotA writing in CERs.

Download the white paper here