our approach aimed at maximizing productivity & efficiency.
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
Yes we provide Food, Cosmetic, Drug and cosmetic label review service.
https://www.fda.gov/medical-devices/overview-device-regulation/device-labeling
https://www.fda.gov/drugs/development-resources/labeling-information-drug-products
Any medical device or new in vitro diagnostic medical device that is imported or manufactured for the purpose of clinical investigation, clinical performance evaluation, testing, evaluation, demonstration, or training must be kept in containers with labels clearly indicating:
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Name of the product or code number
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Batch or lot number
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Serial number (wherever applicable)
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Date of manufacture
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Use-before date
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Storage conditions
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Name and address of the manufacturer
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The specific purpose for which it has been manufactured
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“For Clinical Investigation / Evaluation Only – Not for Sale”
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.
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.
The drug Master Files are divided into 4 Types
Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel
Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
Type III: Packaging Material
Type IV: Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
Type V: FDA Accepted Reference Information
We provide US Agent service and E copy submission service. We also help with DMF preparation.
