Scientific Validity Reports

IVD Regulation 2017/746 introduces many new challenges. One of the most remarkable is the introduction of scientific validity.

  • What is clinical evidence?
  • What is Scientific Validity?
  • How to prove Scientific Validity?

Clinical evidence

While the old IVD directive mainly focused on the provision of analytical performance data and limited clinical performance data, IVD Regulation 2017/746 entails more elaborate requirements in terms of safety and performance with the introduction of the concept ‘clinical evidence’. Clinical evidence consists of clinical data and performance evaluation results, pertaining to a device of sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s) when used as intended by the manufacturer. Confirmation of the conformity of a device with the applicable general safety and performance requirements, in particular those concerning the performance characteristics, shall be based on:

Scientific validity

As defined in the regulation, Scientific Validity means "the association of an analyte with a clinical condition or physiological state".

To demonstrate the scientific validity, a manufacturer will need to use one or a combination of the following sources:

  • relevant information on the scientific validity of devices measuring the same analyte or marker
  • scientific (peer-reviewed) literature identified through a systematic literature review
  • expert opinions/positions from relevant professional associations
  • results from proof of concept studies
  • results from clinical performance studies

All the information collected during this process, should be clearly structured and well-documented in a Scientific Validity Report.

Advantages of outsourcing scientific validity report writing

Writing scientific validity reports based on systematic literature review requires a lot of time and effort and should follow a sound procedure. Moreover, the authors of such reports should possess substantial scientific knowledge, good writing skills and he/she should understand the regulatory background to make sure the report fulfils all requirements.

Ready to roll?

In the best interest of your company, you should outsource your scientific validity reports to external experts. A good regulatory expert who also has extensive experience in the field of IVDs can assist you in meeting this new regulatory requirement with minimal impact on your already stretched resources.

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