IVDR (Regulation on in vitro diagnostic medical devices, Regulation (EU) 2017/746) is the European regulation for in vitro diagnostic medical devices (IVDs) and governs their development, conformity assessment, placing on the market, market surveillance and performance evaluation within the EU. It replaces the former IVD directive and follows a risk-based regulatory approach with considerably higher requirements for clinical and performance-related evidence, technical documentation and post-market surveillance.
- Risk-based classification as the central change
- Significance for human factors and usability engineering
- Performance evaluation instead of clinical evaluation
- Self-testing and near-patient testing
- Performance studies and real-world use
- Typical weaknesses in practice
- Regulatory reference
- Frequently asked questions (FAQ)
Risk-based classification as the central change
One of the most significant changes compared with the former IVDD is the introduction of a rule-based classification system with classes A, B, C and D. The classification is based on the potential risk to patients, users and public health. For many products that were largely assessed under self-certification under the IVDD, the involvement of a notified body is now required. This considerably increases the regulatory depth.
Significance for human factors and usability engineering
The IVDR does not prescribe a particular usability standard but sets requirements for safety, performance and risk management that are directly related to usability. Errors in sample collection, sample handling, calibration, interpretation of results or operation of analyzer systems can lead to incorrect findings and thus to considerable health risks. Accordingly, use-related risks must be identified, assessed and controlled within risk management. In practice, IEC 62366-1 is usually applied together with ISO 14971 for this purpose.
Performance evaluation instead of clinical evaluation
While clinical evaluation is at the center for classic medical devices, the IVDR requires a comprehensive performance evaluation. This typically comprises scientific validity, analytical performance and clinical performance. For usability engineers it is relevant that the actual use situation can influence all three areas, for example through operating errors with point-of-care systems or self-tests.
Self-testing and near-patient testing
Particularly high requirements arise for products for self-use and for near-patient tests. For products for self-use, the intended users are lay persons without medical expertise; near-patient testing, by contrast, involves healthcare professionals who usually have less laboratory diagnostic experience than specialized laboratory staff. In both cases, instructions for use, packaging labeling, error messages and user interfaces become safety-critical. Formative studies and validation activities with representative users therefore gain considerably in importance.
Performance studies and real-world use
The IVDR strengthens the importance of performance studies. In many cases, manufacturers must demonstrate that a product achieves its intended performance under realistic conditions of use. Human factors aspects can play an essential role here if operating errors, comprehension difficulties or misinterpretations influence the diagnostic validity. The close interlinking of performance evaluation and usability engineering is therefore becoming increasingly significant.
Typical weaknesses in practice
Frequent deficits are that use risks are considered exclusively as a training topic or that usability is documented only superficially. Likewise, laboratory devices are often considered only with regard to professional users, although maintenance, service or transport staff can also be relevant user groups. For self-tests, the comprehensibility of labeling and instructions is also regularly underestimated.
Regulatory reference
Regulation (EU) 2017/746 (IVDR) governs the placing on the market and putting into service of in vitro diagnostic medical devices in the European single market and introduces in Annex VIII a risk-based classification system with classes A, B, C and D. It requires performance evaluation and performance evidence for in vitro diagnostic medical devices as well as the application of a risk management system across the entire product lifecycle, whereby use-related risks can be part of this system. The IVDR does not refer explicitly to IEC 62366-1; its requirements for safe and effective use are, however, usually supported by processes according to IEC 62366-1 and ISO 14971.
The IVDR does not refer explicitly to IEC 62366-1 but requires, through risk management and performance evaluation, that operating errors in sample collection, calibration or interpretation of results are controlled systematically, in particular for self-testing and near-patient testing. A process conforming to IEC 62366-1 can meet these requirements in a structured way but does not replace separate IVDR evidence.
Frequently asked questions (FAQ)
Is a usability engineering file required for IVD products?
The IVDR does not require a document with exactly this name. The manufacturer must, however, demonstrate that the relevant requirements of Annex I are met and that use-related risks have been identified, assessed and controlled appropriately. Within the conformity assessment, it can be checked whether this evidence is documented in a comprehensible way; in practice, it is often consolidated in a usability engineering file conforming to IEC 62366-1.
Does IEC 62366-1 also apply to laboratory devices used only by professional staff?
Yes. The standard is not limited to lay users. Experienced laboratory staff can also cause use errors through complex workflows, poor information presentation or inadequate interface design.
Are self-tests particularly critical under the IVDR?
Yes. Because users often have no medical training, comprehension, interpretation and correct performance of the tests become essential safety factors. The expectations of validated usability are correspondingly high.
Does performance evaluation replace usability validation?
No. Performance evaluation primarily examines the diagnostic performance of a product. Usability validation, by contrast, examines whether the intended users can carry out the intended tasks safely and effectively. The two forms of evidence complement each other.
Are you developing an in vitro diagnostic device and want to control use-related risks in line with the IVDR? 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) 2017/746 on in vitro diagnostic medical devices (IVDR)