NEW 2016 In vitro Diagnostic EU IVD Regulation

Following the trilogue, on May 25th 2016, The Netherlands presidency of the Council and representatives of the European Parliament agreed on new rules for in vitro diagnostic medical devices.

Although a political agreement has been reached, the new regulation will have to be approved by the Council and the European Parliament.

Until this approval and publication in the Official Journal of the European Union, anything can change, but we can already distinguish numerous new requirements that will be introduce by this regulation which will impact the IVD industry.

Clinical evidence

One of these major evolutions is for clinical evidence/performance evaluation requirements.

According to the draft of the political agreement, clinical evidence will have to be collected for all IVD devices. Clinical evidences are defined as clinical data and performance evaluation results pertaining to the device of sufficient amount and quality to allow a qualified assessment of whether the device achieves the intended clinical benefit(s) and safety, when used as intended by the manufacturer.

The performance evaluation are based on the assessment and analysis of data to establish or verify the:

  • Scientific Validity
  • Analytical performance
  • Clinical performance

However compared to the current IVD Directive, the new regulation makes the need for clinical data and performance evaluation more explicit and prescriptive.

Learn More: New Medical Device Regulation MDD 2016 – Webinar

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