Human Factors and Usability under EU MDR/IVDR2025-08-29T10:25:54+05:30

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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

  • General Safety and Performance Requirements (Annex I)

    • Annex I, Chapter I, Section 5: Devices must be designed and manufactured in such a way that, when used under the intended conditions, they are suitable for their intended purpose and safe, taking into account the knowledge, experience, education and training, and the environment of the intended users. This directly requires considering human factors.
    • Annex I, Chapter II, Section 14.2 (c, d, e): Usability of controls, displays, and user interfaces must minimize use error. Instructions for use, training needs, and design elements must support safe use.
    • Annex I, Section 23.4 (IFU requirements): Information must be understandable by the intended user (patient, lay user, healthcare professional).
  • Integration with Risk Management

    • Human factors are tied to risk management per ISO 14971.
    • MDR requires identification and reduction of use related risks (errors due to design, labelling, IFU, etc.).
    • Risk benefit analysis must account for misuse risks foreseeable with normal use.
  • Clinical Evaluation / Performance Evaluation connection

    • Clinical data must show that users can operate the device safely and effectively.
    • Any user related issues identified in clinical investigations, PMCF (Post-Market Clinical Follow-up), or vigilance must feed back into usability updates.
    • Any user related issues identified in Performance evaluation Post Market Performance Follow Up (PMPF), or vigilance must feed back into usability updates.
  • Documentation in the Technical File

    Manufacturers must include a Usability Engineering File (per ISO 62366-1) inside the Technical Documentation:

    • User profiles (who will use it – clinician, patient, lay caregiver).

    • Intended use environments (hospital, home, ambulance, etc.).

    • Critical tasks and associated use errors.

    • Formative and summative usability evaluations.

    • Residual use related risks and mitigations.

    • Traceability between risk analysis (ISO 14971), usability findings, and final design

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service related FAQ’s

Do you provide Label Review Service?2025-07-31T10:11:53+05:30

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

 

Labelling Requirements for Medical and In Vitro Diagnostic Devices for Clinical Use2025-08-16T05:58:13+05:30

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:

  • Name of the product or code number

  • Batch or lot number

  • Serial number (wherever applicable)

  • Date of manufacture

  • Use-before date

  • Storage conditions

  • Name and address of the manufacturer

  • The specific purpose for which it has been manufactured

  • “For Clinical Investigation / Evaluation Only – Not for Sale”

Is biocompatibility testing always required for biological evaluation?2025-08-04T12:32:38+05:30

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.

Transfer of US Agent Possible? Explain the process2025-07-31T14:12:58+05:30

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.

US FDA DMF2025-07-31T10:14:58+05:30

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.

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