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Human Factors and Usability under EU MDR/IVDR
The European Union Medical Device Regulation (EU MDR 2017/745) and the In Vitro Diagnostic Medical Device Regulation (EU IVDR 2017/746) place strong emphasis on human factors and usability engineering as integral parts of device safety and performance. Both regulations recognise that many adverse events and device related incidents are caused not by technical malfunctions but by use errors linked to poor design, unclear instructions, or failure to consider the abilities and limitations of the intended users.
To address this, MDR and IVDR require manufacturers to demonstrate that devices are designed and manufactured in a way that ensures safe, effective, and intuitive use across the full range of intended users whether healthcare professionals, patients, or lay-man and within the environments where the devices will be used, such as hospitals, laboratories, or home settings. These requirements are reflected in the General Safety and Performance Requirements (Annex I) of both regulations, which specifically call for usability considerations in areas like labeling, instructions for use, device interface, and risk control.
Compliance is closely tied to standards such as ISO 62366-1 (Usability Engineering for Medical Devices) and ISO 14971 (Risk Management), ensuring that usability is systematically evaluated throughout design, risk management, and clinical evaluation. For IVDs, usability plays a crucial role in preventing misinterpretation of test results, ensuring that lay users and professionals alike can operate devices correctly and consistently.
In short, under EU MDR and IVDR, human factors and usability are not optional, they are mandatory requirements that must be addressed in the technical documentation, risk management files, and clinical/performance evaluation reports to achieve CE certification.
MDR 2017/745 Requirements on Human Factors & Usability
predictive machines
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certified factory
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service related FAQ’s
Absolutely. We can take over PMCF activities for devices already CE-marked and on the EU market, ensuring that your data collection, evaluation, and reporting fully meet MDR requirements — even if your existing documentation needs corrective action before the next Notified Body audit.
Yes. Under EU MDR 2017/745, PMCF is a mandatory and ongoing activity for all CE-marked medical devices, regardless of risk class. The extent of PMCF activities may vary depending on the device’s risk profile, clinical history, and available data.
Yes. According to MDR and IVDR requirements, the EC REP’s name and address must be clearly visible on the product labeling, outer packaging, or accompanying documents, allowing EU authorities to easily identify the representative.
Yes. We help you identify the most suitable Notified Body based on your device type, risk class, and review timelines and support you throughout the submission and technical documentation review process.
After Brexit, UKCA replaced CE marking in Great Britain. Manufacturers must comply with MHRA rules to legally place devices on the UK market.
