Compliance with ISO 13485 and EU MDR/IVDR require clear evidence of effective control over measuring and monitoring processes, equipment, and calibration—a requirement that is easy to underestimate or overlook.

EN ISO 13485:2016/A11:2021 contains a section (7.6) dedicated to the control of monitoring and measuring equipment, which includes both a determination of the monitoring and measurements to be taken and the equipment needed to provide evidence of conformity of products to applicable requirements. As part of the harmonization of the ISO 13485 standard, this section is identified as covering the legal requirements specified in both the EU 2017/745 MDR & 2017/746 IVDR (specifically as part of conformity assessments in Annex IX & XI).

The accuracy, precision, and stability of devices with diagnostic or measuring function are also identified in the GSPR of both the MDR (#15) and IVDR (#14), with reference to appropriate scientific and technical methods and identification of the limits of accuracy.

Additional guidance can be found in the international standard ISO 10012 which is applicable to any organization where measurement processes influence product quality and addresses both the technical and management aspects of measurement systems by:

  • ensuring that measurement processes and equipment support product conformity requirements, and
  • providing confidence in the accuracy and reliability of measurement results.

To be compliant, manufacturers typically need to consider a wide range of activities including:

  • unique identification of each piece of measuring equipment and its calibration status, including relevant labelling.
  • scheduling of calibration appropriate to the equipment type, usage frequency and risk of incorrect measurements
  • performing calibrations using standards traceable to national or international norms (or provide detailed rationales for the choice of other methods)
  • regular verification of equipment accuracy using control samples or secondary standards
  • safeguarding against adjustments invalidating measurement results and protection from damage and deterioration during handling, maintenance, and storage (including control of the relevant environment).
  • validation of software used for monitoring and measurement, with risk–based approach for revalidation, particularly after changes.
  • training personnel in equipment use, calibration and maintenance.
  • handling nonconformities related to out of specification equipment, including recalibration or replacement and impact assessment on previously productions based on potentially incorrect measurements.
  • maintenance of records in a format accessible to audits & inspections.

The content in the organization’s standard operating procedures therefore needs to clearly establish a standardized workflow for the control, calibration, and maintenance of measuring and monitoring equipment used in production, testing and inspection. 

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Human Factors Engineering (HFE) or Usability Engineering (UE) isn’t just about functionality and regulatory compliance, it’s about ensuring that devices are safe and easy to use for the end users by understanding human capabilities and limitations.

The evolution of usability guidelines and standards for medical devices highlights an increasing recognition of the crucial role human factors play in device safety. The International Organization for Standardization (ISO) began formally addressing usability in the early 2000s. The development of ISO 13485 (Quality Management Systems for Medical Devices) underscored the importance of incorporating user-centered design into quality management processes.

The publication of IEC 62366 in 2007 marked another significant milestone in usability engineering. This standard outlines the process for manufacturers to analyze, define, develop, and evaluate the usability of medical devices. It establishes detailed requirements for usability engineering to ensure that medical devices are designed to minimize use errors and enhance overall safety. It emphasizes the necessity of usability testing throughout the product development lifecycle to identify and mitigate potential use-related risks.

In 2016, the FDA issued a guideline on Applying Human Factors and Usability Engineering to Medical Devices, emphasizing the importance of usability in medical devices. The FDA’s guidance highlights the necessity for manufacturers to conduct comprehensive usability testing and demonstrate that devices are designed to minimize the potential for use-related errors. While there are many similarities between EU and US requirements, key differences exist.

For instance, the FDA stresses that testing should involve representative groups of users likely to operate the device in each of its intended contexts. The guidance also recommends that the number of participants shall be sufficient to identify usability issues effectively, suggesting a minimum of 15 participants. In contrast, the EU’s requirements, particularly those outlined in the ISO 62366 standard, do not specify a minimum number of participants but emphasize involving representative users throughout the usability testing process. Both regions recognize the necessity of evaluating devices in real-world scenarios, but the FDA provides a more defined framework on participant characteristics and study design.

Additionally, while the FDA emphasizes the importance of human factors and usability testing as part of the device approval process, the ISO 62366 standard, which is closely aligned with EU regulations, mandates a systematic approach to usability engineering throughout the product lifecycle. This approach includes assessing the device’s usability and integrating user feedback into design revisions to enhance safety and performance as part of post-market requirements.

The IEC 60601 series of standards, which focus on the safety and effectiveness of medical electrical equipment, have also incorporated usability considerations in later revisions. These standards now require manufacturers to assess usability as part of the risk management process (including identification of use related hazards), recognizing that use errors can result in significant risks.

The focus on usability engineering is well-justified. A 2018 study by Johns Hopkins estimates that over 250,000 deaths occur annually in the U.S. due to medical errors, many of which are related to human factors. While Europe may not have a unified study directly comparable to those in the U.S., several studies and reports highlight similar challenges across the European healthcare systems, thereby underscoring the importance of Usability Engineering.

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International Congress on Quality in Laboratory Medicine and Health Tech

Labquality Days is one of Northern Europe’s largest annual international congresses focusing on quality in laboratory medicine and health technology. The inspiring atmosphere of the annual scientific congress gathers medical laboratory and health technology professionals together to exchange ideas and meet colleagues. Theese days brings almost 100 speakers to the stage. The speakers are experts in social and healthcare quality management, laboratory medicine, and medical devices.

Join us to hear the latest developments in these fields and spend a couple of days in the capital of Finland! You will find more information on our website.

Hurry up!
Super early bird rate until 30 November 2024
One-day rate: 530 €
Two-day rate: 570 €

Early bird rate from 1 December 2024 until 31 January 2025
One-day rate: 640 €
Two-day rate: 680 €

Normal rate 1 – 7 February 2025
One-day rate: 710 €
Two-day rate: 750 €

Group rate
Two-day rate for three people: 1560 €

See what’s included in the congress rates here.

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The EU Commission is urged to propose solutions by no later than the end of Q1, 2025.

The revisions will seek to address the many challenges and bottlenecks associated with placing and maintaining medical devices within the EU market, particularly from the perspective of manufacturers and notified bodies (NB) in ensuring timely access to safe medical device products throughout the EU.

This will likely include a systematic revision to all relevant articles of the MDR 2017/745 and IVDR  2017/746 and subsequent impact assessment, to be proposed no later than Q1 2025. Any new rules will be linked to appropriate transition periods.

Some of the highlights from the full text TA-10-2024-0028_EN

  • Stressing that access to medical device products should not depend on where in the EU a patient is located.
  • Encouraging NBs to ensure sufficient resources exist to meet demands in a timely manner
  • Creation of transparent and binding timelines, including clock stops for procedural steps in conformity assessment by NBs to avoid uncertainty for manufacturers.
  • Reducing administrative overhead without a reduction in patient safety and provide support in particular to small and medium business enterprises (SMEs).
  • Eliminating unnecessary recertification requirements for certain updates via harmonized procedures.
  • Exploring fast-tracks and prioritization pathways for approval of areas in unmet medical need or public health emergencies
  • Including e-health devices within the scope of the MDR to protect collected health data

Urgent full implementation of the EUDAMED database to allow better access of information and transparency for the public and healthcare professionals, with a focus on monitoring of device availability such that actions can be taken to keep them available in the EU market (particularly for ‘last of type’ device examples).

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