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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
After Brexit, UKCA replaced CE marking in Great Britain. Manufacturers must comply with MHRA rules to legally place devices on the UK market.
Yes, manufacturers / exporter any time they can transfer the US Agent. We are happy to act as US Agent for any non-US manufacturers. Please bring us the FDA FURLS account login details to update the Agent Information.
Not always. If sufficient historical data or literature exists to demonstrate the safety of materials used in the device, some tests may be waived. A gap analysis helps determine whether existing data is adequate or if additional testing (e.g., cytotoxicity, irritation, sensitization) is required to meet regulatory expectations.
Its highly recommended to conduct testing of finished salable device before you apply for regulatory clearance.
Absolutely. In addition to EC REP services, we offer end-to-end regulatory consulting, including Notified Body selection, technical file preparation, and gap analysis to support your CE Marking journey efficiently.
Yes, GMP compliance is mandatory for medical device manufacturers who market products in the United States. The FDA enforces GMP through the Quality System Regulation (21 CFR Part 820), which outlines the minimum requirements for design, production, labeling, packaging, and storage of medical devices to ensure safety and effectiveness.
