Clinical Evidence and Performance Evaluation

The IVDR (article 56 and Annex XIII) reinforces the need for clinical evidence to demonstrate conformity with the relevant general safety and performance requirements.

Performance evaluation of a device is a continuous process by which data are assessed and analysed to demonstrate the scientific validity, analytical performance and clinical performance of that device for its intended purpose as stated by the manufacturer.

To plan, continuously conduct and document a performance evaluation, the manufacturer shall establish and update a performance evaluation plan. The performance evaluation plan shall specify the characteristics and the performance of the device and the process and criteria applied to generate the necessary clinical evidence.

The performance evaluation shall be thorough and objective, considering both favourable and unfavourable data.

The manufacturer shall assess all relevant scientific validity, analytical and clinical performance data to verify the conformity of its device with the general safety and performance requirements as referred to in Annex I. The amount and quality of that data shall allow the manufacturer to make a qualified assessment whether the device will achieve the intended clinical benefit or benefits and safety, when used as intended by the manufacturer. The data and conclusions drawn from this assessment shall constitute the clinical evidence for the device. The clinical evidence shall scientifically demonstrate that the intended clinical benefit or benefits and safety will be achieved according to the state of the art in medicine.

The clinical evidence shall be documented in a performance evaluation report. This report shall include the scientific validity report, the analytical performance report, the clinical performance report and an assessment of those reports allowing demonstration of the clinical evidence.

Demonstration of the clinical performance of a device shall be based on one or a combination of the following sources:

  • clinical performance studies;
  • scientific peer-reviewed literature;
  • published experience gained by routine diagnostic testing.

 

Clinical performance studies shall be performed unless due justification is provided for relying on other sources of clinical performance data.

The clinical evidence and its assessment in the performance evaluation report shall be updated throughout the life cycle of the device concerned with data obtained from the implementation of the manufacturer’s Post Market Performance Follow Up plan in accordance with Part B of Annex XIII, as part of the performance evaluation and the post-market surveillance system referred to in Article 10(9). The performance evaluation report shall be part of the technical documentation.

in In-Vitro Diagnostic Medical Device Regulation