MDR (Medical Device Regulation, Regulation (EU) 2017/745) is the EU regulation on medical devices. It defines the regulatory requirements for placing on the market, putting into service and market surveillance of medical devices in the European Union, with a strong focus on safety, performance, risk management and usability.
MDR and usability as a regulatory requirement
Compared with the former medical device directives, the MDR does not treat usability as an isolated design topic but as an integral part of safety and performance. The user interface must be designed so that risks due to ergonomic features, the intended use environment, foreseeable misuse and possible use errors are reduced as far as possible. Usability is thus closely linked to risk management and the intended purpose. The MDR does not require an isolated “usability proof” but robust evidence that risks arising from use have been controlled systematically.
Relationship with IEC 62366-1
The MDR does not name IEC 62366-1 explicitly. In practice, however, this standard is used as the established state of the art for usability engineering of medical devices. The usability engineering process helps manufacturers to identify use requirements, analyze potential use errors, describe hazard-related use scenarios and demonstrate the effectiveness of risk controls through formative and summative evaluations. The results typically feed into the technical documentation.
Link with risk management
The MDR requires continuous risk management across the entire product lifecycle. Use-related risks do not form a risk category defined separately by the MDR but must be integrated fully into the uniform risk management system of the product. For human factors and usability engineering teams this means that use scenarios, foreseeable misuse, user characteristics and use environments must be integrated systematically into the risk analysis. The interface between IEC 62366-1 and ISO 14971 is therefore one of the central regulatory topics for medical devices.
Significance of the intended purpose
The intended purpose (intended use) defined by the manufacturer influences almost all regulatory and usability-relevant activities. Among other things, it defines user groups, use environments, clinical use cases and limits of use. Changes to the intended purpose can have direct effects on use risks, instructions for use, training concepts and validation requirements. An insufficiently specified intended purpose often leads to gaps in the analysis of use and context of use.
Technical documentation and evidence
The MDR requires extensive technical documentation to substantiate safety and performance. For usability engineering this typically means documenting the use specification, use-related risk analysis, user interface specification, formative assessments and summative validation activities. In the conformity assessment, notified bodies review the technical documentation and thus also the traceability of the link between identified use risks, risk controls and the respective validation evidence; the depth and scope of the review depend on the product class and the conformity assessment procedure.
Typical weaknesses in MDR projects
Similar deficits frequently occur in audits and reviews:
- Missing link between risk analysis, use errors and safety-relevant use scenarios
- Formative studies without documented design decisions
- Summative studies with insufficient justification of the sample
- Focus on general satisfaction instead of safety-relevant use
- Incomplete consideration of foreseeable misuse
- Missing consistency between intended purpose, instructions for use and validation
Such weaknesses can lead to queries from notified bodies and to delays in the conformity assessment procedure.
Regulatory reference
Regulation (EU) 2017/745 (MDR) requires in Annex I that devices must be suitable for their intended purpose under normal conditions of use and demonstrate safety and performance; risks associated with use are to be reduced through safe design, protective measures and the provision of information. According to Article 5, medical devices may only be placed on the market if they meet the MDR requirements and are suitable for their intended purpose. IEC 62366-1 describes a systematic usability engineering process for identifying and controlling use-related risks, and ISO 14971 requires the identification, evaluation, control and monitoring of risks across the entire product lifecycle, including use-related risks. The FDA human factors guidance expects the identification of critical tasks and their validation under representative conditions of use. For internationally marketed products, a joint human factors strategy for FDA and MDR requirements is often developed.
The MDR does not name IEC 62366-1 by name but requires, through Annex I and continuous risk management, the systematic control of risks from ergonomic features, use environment and user interactions. IEC 62366-1 specifies a recognized process with which manufacturers can address and document these requirements in a structured way. The standard does not replace the MDR requirement. It is currently not harmonized under the MDR but is regarded as the recognized state of the art and thus as the established route to demonstrating compliance.
Frequently asked questions (FAQ)
Is carrying out a summative usability study always mandatory under the MDR?
Not necessarily in every conceivable case. In practice, however, robust validation evidence is required for most medical devices when safety-relevant user interactions are present. The scope and design depend on risk, product characteristics and use environment.
Does the MDR explicitly require IEC 62366-1?
No. The MDR does not name the standard directly. IEC 62366-1 is, however, generally regarded as the established state of the art for controlling use-related risks.
Is a risk analysis without a usability test sufficient?
As a rule, no. The risk analysis identifies risks and measures but does not automatically prove their effectiveness. For safety-relevant user interactions, empirical validation evidence is usually required.
Do you want to build your usability evidence in an MDR-compliant and audit-proof way? We support you throughout the usability engineering process according to IEC 62366-1.
More about our usability engineeringSources
- IEC 62366-1:2015+AMD1:2020, Medical devices, Part 1: Application of usability engineering to medical devices
- ISO 14971:2019, Medical devices, Application of risk management to medical devices
- Regulation (EU) 2017/745 on medical devices (MDR)