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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
Yes, we provide full support for UDI implementation and registration in compliance with EU MDR 2017/745 and IVDR 2017/746 requirements. Our team assists manufacturers in assigning and structuring UDI-DI and UDI-PI codes based on the device classification and intended use. We also help in ensuring proper placement of UDI on labeling, packaging, and Instructions for Use (IFU), as well as preparing for UDI module submission once it becomes fully functional within EUDAMED.
Our services cover:
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UDI-DI and UDI-PI structure guidance
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Compliance with GS1, HIBCC, or ICCBBA issuing agencies
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UDI label and packaging review
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Preparation for EUDAMED UDI/Device registration module
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UDI-related documentation for your Technical File and CE submission
By integrating UDI properly, we help ensure device traceability, reduce market delays, and support full regulatory compliance across the EU.
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”
The timeline varies based on device class and documentation readiness. Class I devices may take a few weeks, while Class IIa, IIb, and III devices requiring Notified Body review may take 6–12 months or more.
Form MD-22: This is the application form submitted to the Central Licensing Authority (CLA) (i.e., DCGI under CDSCO) to seek permission for conducting a clinical investigation of a new medical device or an investigational medical device without a predicate device in India.
Form MD-23: If the CLA is satisfied with the application, it grants permission to conduct the clinical investigation through Form MD-23. This permission allows the sponsor to begin the study in accordance with an approved clinical investigation plan reviewed by a registered Ethics Committee.
Additional requirements:
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The clinical investigation must be registered with the Clinical Trials Registry – India (CTRI) before the enrolment of the first participant.
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The first participant must be enrolled within one year of the grant of permission; otherwise, fresh permission from the CLA is required.
The 510(k) file includes documents used to establish the safety and efficiency of the proposed medical device through substantial equivalence. The documents included in the 510(k) file are:
- Form FDA 3601: Medical Device User Fee Cover Sheet (MDUFC sheet)
- FDA Form 3514- CDRH Premarket Review Submission Cover Sheet: This document includes basic administrative and device information.
- 510(k) Cover Letter: This document provides a brief idea about the purpose of the submission, device, manufacturer and the U.S agent (if any).
- FDA Form 3881: Indications for Use Statement
- 510(k) Summary or 510(k) Statement: This includes a summary of the device undergoing the 510(k) clearance.
- Truthful & Accuracy Statement: This is to certify that the 510(k) submission contents are truthful and accurate and no information omitted.
- Class III Summary and Certification: If the proposed device is a Class III exempt from PMA, otherwise, this can be marked as not applicable.
- Financial Certification or Disclosure Statement: This is applicable only if clinical studies were conducted
- Declarations of Conformity and Summary Reports: Lists the voluntary consensus standards used and includes DOC to such standards.
- Device Description: This document includes the description of the device design requirements and performance specifications.
- Executive Summary: a brief description of the device & comparison table with the predicate device identified.
- Substantial Equivalence Discussion: Detailed comparison between the proposed device and the predicate device chosen.
- Proposed Labeling: Is discussed in detail to comply with 21 CFR 807.87(e) for general medical devices and 21 CFR 809.10 for IVD’s
- Sterilization and Shelf Life: This document provides details regarding the sterilization and shelf life claim being made.
- Biocompatibility: This document is applicable if the proposed device comes into direct or indirect contact with the human body tissue.
- Software: This includes the documentation for any software used in the proposed device
- Electromagnetic Compatibility and Electrical Safety- If the proposed device is powered electrically, in which case the EMC must be evaluated.
- Performance Testing – Bench: This document included details of the bench tests performed to evaluate the efficiency of the proposed device.
- Performance Testing – Animal: This document included details of the animal testing performed to evaluate the efficiency of the proposed device.
- Performance Testing – Clinical: This document included details of the clinical studies performed to evaluate the efficiency of the proposed device.
The completed FDA 510(k) file is submitted in electronic format as an e-copy to the FDA. The submission package is sent to the CDRH through registered mail or commercial delivery service.
