Management of User Interfaces of Unknown Provenance (UOUP) in Medical Devices according to the IEC 62366-1:2015 + A1:2020 Standard
15/10/2024

With the implementation of European Regulation (EU) 2017/745, both the official texts and the authorities are placing particular emphasis on user interfaces, aiming to minimize use errors and thus ensure the safety and effectiveness of medical devices. The IEC 62366-1:2015 + A1:2020 standard, entitled “Application of usability engineering to medical devices”, aims to guide manufacturers in applying this process during the development of new medical devices. In its Annex C, the standard sheds light on the management of “User Interfaces of Unknown Provenance” (UOUP), thus providing a framework for assessing and mitigating the risks associated with these interfaces.
Definition of a “User Interface of Unknown Provenance”
The term UOUPs refer to the user interfaces or parts of the user interfaces of a medical device already marketed prior to the publication of the current edition of the IEC 62366-1 standard in 2015. These user interfaces may not have been developed according to the usability engineering process described in the standard and are therefore considered unknown.
The alternative UOUP process enables manufacturers to apply certain tools defined in the standard to the user interfaces of their medical devices in order to demonstrate regulatory compliance with safety and effectiveness requirements. This process provides manufacturers with a methodology adapted to the one described in the standard.
However, it is important to note that any changes made to the user interfaces since publication of the standard exclude these modified parts from being categorized as UOUPs. These parts are no longer considered as such and must comply with the classic process specifications outlined in chapters 5.1 to 5.8 of IEC 62366-1:2015.
The diagram below illustrates the main differences between medical devices marketed before and after 2015 in terms of UOUPs according to IEC 62366-1:2015.

What methodology is used to establish the file for a “User Interface of Unknown Provenance”?
To ensure that a UOUP complies with IEC 62366-1:2015, and more specifically its Annex C, a five-step process is proposed:
- Develop the specifications for use: the manufacturer must define the “specifications for use” which include the intended medical indication, the target patient population, the relevant body part or tissue type with which the medical device interacts, the profile of the intended users, the environment of use, as well as the operating principle of the device. This step is identical to that described in section 5.1 of the standard.
- Examine Post-Production Information: to detect potential use errors that could lead to dangerous situations, the manufacturer must analyze all available post-production information, such as complaints, field incident reports, as well as data from post-market surveillance (PMS). It is crucial that the data used for this analysis focuses on the actual use of the medical device, highlighting errors in use by patients, practitioners, etc. PMS must be rigorously conducted and provide actionable data to ensure the effectiveness of the review and the entire process.
- Review Usability-Related Risk Analysis: the manufacturer must review the risk analysis to ensure that hazardous phenomena and situations associated with usability are correctly identified and documented. If new hazards are discovered during the review of post-production data, the risk management file must be updated.
- Control the Risks Related to Use: the manufacturer must assess all risks associated with the use of the device, verify and document the implementation of risk control measures, and ensure that all these risks are reduced to an acceptable level. If the manufacturer determines that modifications to the user interface are necessary to reduce the risk to an acceptable level, then these modifications should not be considered as a UOUP. The manufacturer shall follow all the activities described standard IEC 62366-1, chapters 5.1 to 5.8, for the consequently modified parts of the medical device.
- Evaluation of the Overall Residual Risk of the Medical Device: after completing the previous steps, the manufacturer is required to reassess the overall residual risk in accordance with ISO 14971:2019.
The usability methodology for “UOUPs” differs slightly from that for standard medical devices, notably in the absence of formative and summative studies. All these activities can be recorded in a specific file.
Conclusion
IEC 62366-1:2015 encourages manufacturers to integrate usability engineering at every stage of medical device development, including for UOUPs marketed before 2015. By identifying these UOUPs and adopting an approach based on use specifications, post-production data from PMS and risk control in accordance with Annex C, manufacturers can assess and mitigate the risks associated with correct use and misuse, thereby ensuring the safety, efficacy and regulatory compliance of their medical devices.
Need help?
Efor Group can support you in optimizing the usability of your UOUPs, implementing IEC 62366-1:2015 and in drafting your usability reports and documents. Our Technical Department can be contacted directly at onedt@efor-group.com.
Efor group
Our CSR commitments
Aware of our social and environmental responsibility, we act every day to make a positive impact on society.
Our news
Discover all our technical articles and news