Newsletter No 38 October 2023

Subject: Usability engineering in the context of the MDR

In the context of Regulation (EU) 2017/745 on medical devices (MDR), the design and functionality of the devices have acquired a higher importance. In this sense, usability engineering plays a central role as becomes key to meet the requirements on safety and effectiveness.

What is usability engineering?
Usability engineering is a systematic and iterative process that aims to optimize the interaction between users and medical devices. This process is essential for creating devices that are not only efficient but also safe and user-friendly, and it is also for legacy devices to ensure their continued safety and efficacy.
1. Usability Evaluation: Manufacturers are expected to conduct usability evaluations to assess how these devices are used in practice. Gathering feedback from users and identifying potential use-related hazards can be valuable in improving the devices’ safety and usability.
2. Risk Management: Usability-related risks are assessed and mitigated for legacy devices as well. This includes identifying any use-related hazards and taking steps to minimize associated risks.
3. Post-Market Surveillance: Continuous monitoring of devices’ real-world performance is essential. Usability-related issues that emerge post-market must be identified, assessed, and addressed promptly along the device’s lifecycle.
Usability engineering principles are outlined in standard EN 62366-1.

Which is the role of the distributors?
Distributors play a crucial role in ensuring the usability of medical devices on the market, and their responsibilities have been significantly expanded under MDR. Below there are a few examples:
• Feedback collection: Distributors often have direct contact with users and healthcare facilities. They can serve as a valuable conduit for collecting feedback and insights on device usability issues. This feedback can be shared with manufacturers and authorities to drive improvements and address usability concerns promptly. In this regard, it is of paramount importance for manufacturers to get the feedback from usability questionnaires sent downstream to the distribution chain to better collect feedback in a systematic way.
• Market surveillance and vigilance: distributors are required to cooperate with manufacturers and competent authorities in the surveillance of the devices they distribute. They must report any incidents or serious risk related to the devices. This is significant for usability since it helps identify and address usability issues that may arise in real-world use.
• Supply Chain Management: Distributors play a role in managing the supply chain for medical devices. Ensuring that devices are stored, transported, and delivered under appropriate conditions is essential for maintaining their usability. Improper handling or storage can impact device functionality and safety.
• User Training and Support: While the primary responsibility for providing user training and support lies with manufacturers, distributors can still play a part in disseminating information about device use, maintenance, and troubleshooting to end-users. This contributes to the overall usability of the device by ensuring users are well-informed.
• Recalls and Market Withdrawals: In cases where medical devices are found to have usability-related issues that pose significant risks, distributors may be involved in the recall or withdrawal of such devices from the market. Their cooperation in these processes is vital for the safety and usability of devices.
• Verification of Compliance: Distributors are now legally obligated to verify that the medical devices they distribute comply with the MDR. This includes verifying that the devices bear the CE marking and are accompanied by the required documentation, such as the Declaration of Conformity and Instructions for Use (IFU). Ensuring the presence of accurate and clear IFUs, when applicable, is vital for the usability of devices, as they provide essential information for users.

By adhering to usability engineering guidelines, manufacturers can ensure that their medical devices meet the highest standards of safety and efficacy. Distributors, on the other hand, contribute to the overall safety and usability of medical devices. The good communication between both roles ultimately benefits patients and healthcare professionals.

This newsletter is part of our campaign to increase the sensitivity and the awareness of all our business partners, to bring more clarity around the MDR journey and challenges and opportunities around the MDR Art.22 “Systems and Procedure Packs”.

We are already today all dependent on efficient cooperation. For the MDR implementation, we require even closer collaboration to ensure we all can deliver safe supplies to hospitals and patients in the future.

We are confident we will continue to supply health care competently on customized surgical procedure sets and small kits.

Do you wish to know more about specific MDR topics? Do you have any questions or comments about STS newsletter?
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The next MDR newsletter will be issued in November. We wish everyone a pleasant month.

Augusto Orsini
CEO STS Medical Group

Meritxell Laguna
Group Manager Regulatory Affairs
STS Medical Group