Riccardo Chiarini -

The Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR) require the demonstration of compliance with the General Safety and Performance Requirements (GSPRs) for medical devices and in vitro diagnostic devices.

In line with the provisions of MDR Article 61 (1) and IVDR Article 56(1), the clinical/performance evaluation should be appropriate in view of the device claims and characteristics.

In case the demonstration of conformity with GSPRs based on clinical data is not deemed appropriate, the manufacturer shall demonstrate conformity based on the results of performance evaluation, bench testing, preclinical evaluation, and usability assessment.

Usability testing aims to verify how the user interacts with a device and is a key part of overall device risk management and safety, ensuring that the device is safe and effective for the end users. Notably, the approval of a device is frequently deferred or even rejected if the manufacturer does not provide sufficiently positive usability testing data.

Usability tests can also aim to assess the usability and appeal of the device that have commercial relevance but are outside of regulatory expectations

Usability testing should be managed according to the intended use environment and intended users of the device, taking into consideration for example whether the device might be used in a hospital or at home, by health professionals or unskilled patients or caregivers, etc. Intended users are asked to perform specific tasks with the device, in order to evaluate its interactive qualities. Desirable interactive qualities include attributes such as ease of learning, ease of use, and avoidance and recovery from a possible misuse.

Usability testing should include four main steps:

  1. planning (defining test environment, representative users and goals, and developing a test protocol and other documents required)
  2. recruiting
  3. test conduction (including evaluation of the users’ interactions with the device and final interview)
  4. analysis of the results and findings.

Regulatory Pharma Net (RPN) is available to provide your company with any updates on the device regulatory framework and to assist on all regulatory needs including the conduction of usability tests for your medical devices and in vitro diagnostic devices.

Feel free to contact us at info@regulatorypharmanet.com

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