Project

Need

The calibration and testing of medical electrical devices, alongside the verification of biomedical measurements, are critical imperatives within the global healthcare industry. While millions of medical devices are deployed daily, the metrological landscape in Europe remains fragmented. Many member states currently lack the NMI-level infrastructure required for high-voltage/high-current impulse measurements and high-frequency power traceability. This capability gap results in inconsistent calibration performed by secondary laboratories without access to primary standards, leading to non-traceable measurements that directly compromise the reliability of life-critical equipment.

The safe and effective operation of medical electrical devices—particularly defibrillators and electrosurgical units (ESUs)—depends on the accurate, traceable measurement of high-energy impulses and high-frequency power. Defibrillators deliver life-saving shocks up to 360 J, while ESUs operate at approximately 1 MHz with power levels up to 300 W. Even minor deviations in these outputs can lead to catastrophic consequences, such as treatment failure, severe tissue burns, or fatal cardiac complications. Despite these risks, a substantial proportion of medical measurement systems remain inadequately calibrated, constituting an underappreciated and avoidable source of medical error. The clinical community often underestimates these risks, yet the inherent dangers of non-traceable diagnostic and therapeutic procedures are a significant burden on healthcare quality.

Furthermore, diagnostic modalities such as electrocardiography (ECG) and electroencephalography (EEG) are essential for capturing the body’s low-level bioelectrical activity. Accurate ECG measurements underpin arrhythmia detection and emergency response, while precise EEG signals support seizure diagnosis and neurological assessment. However, full metrological traceability for these microvolt-level, complex time-domain signals is still lacking across Europe. This gap is further exacerbated by the rigorous requirements of the EU Medical Device Regulation (MDR) (EU) 2017/745. Manufacturers, particularly Small and Medium Enterprises (SMEs), struggle to demonstrate conformity due to the absence of harmonized European reference systems, making the approval process time-consuming and costly.

To address these challenges and scale medical innovation, a robust metrological framework is urgently needed. This framework must include metrologically characterized reference systems for benchmarking (Objective 1 and 3) and advanced AI/ML-enabled algorithms for waveform parameter determination and data processing (Objective 2). In line with the UN Economic and Social Council’s resolution to “better leverage open-source technologies for sustainable development,” Met4MED aims to establish open-source hardware and software blueprints. By providing modular, flexible, and traceable calibration systems, the project will facilitate regulatory compliance under the MDR, reduce the financial burden on healthcare systems, and ensure that medical practitioners have the reliable tools necessary to improve clinical outcomes and patient safety across the EU.

Objectives

The overall goal of this project is to establish a basis for future updates of European regulations and to disseminate these to health communities, particularly medical equipment calibrator manufacturers and calibration service providers as best practice guidance. New calibration setups which are reproducible, fully
documented and metrologically characterised will be developed in the project which also create links to the EURAMET network via earlier projects. The technical documentation for the design and production process of the reference system will be realised in accordance with the requirements of the EU medical device regulation (MDR) (EU)2017/745. Open-source platform and the use of Artificial Intelligence/Machine Learning (AI/ML) such as CNN (Convolutional Neural Network) and/or FFT (Fast Fourier analysis) methods will provide users with more direct and improvable measurements.

The specific objectives of the project are:

1. To develop high-voltage (HV) and high-current (HC) impulse measurement equipment and analysis algorithms for pulse waveform parameter determination to establish a defibrillator analyser calibration system up to 360 J with 0.3 % impulse energy measurement uncertainty. In addition, to develop high-precision broadband generation and measurement equipment and analysis algorithms for modulated waveform parameter determination to establish a calibration system for ESU analysers up to 1 MHz and 300 W with 2 % high-frequency power measurement uncertainty. To develop calibration techniques and to ensure robust traceability for defibrillators and electrical surgery units.
2. To develop a metrological traceability route with procedures and uncertainty analysis for ECGs and EEGs by investigating techniques for time-domain characteristics of ECGs and EEGs low-level voltage waveforms (10 µV to 5 mV, 0.05 Hz to 150 Hz). Then to develop and validate a reference measurement system using sampling techniques for the traceable calibration of EEG and ECG simulators, aiming for an uncertainty of 1 % in the voltage amplitude and 1 ms in time intervals measurements. To develop calibration techniques and to ensure robust traceability for ECGs and EEGs.
3. To establish measurement traceability of bioimpedance analysers in an extended frequency and magnitude range (up to hundreds of kHz, 10 Ω to 100 kΩ). In addition, to investigate the limitations of using indirect primary bioimpedance standards (phantoms, empirical models) by characterising the frequency-dependence of the human body impedance network and then to develop suitable reference systems and verification techniques with an uncertainty of 0.3 %. To develop calibration techniques and to ensure robust traceability for bioimpedance measurements.
4. To facilitate the take up of the technology and measurement infrastructure developed in the project by the measurement equipment (medical electrical device manufacturers), standards developing organisations (e.g. ISO, IEC) and end users (e.g. clinical stakeholders, manufacturers of medical and healthcare products).

Progress beyond the state of the art and results

Objective 1: Traceability for defibrillator and electrosurgical analysers

Current traceability for medical electrical devices is fragmented; calibrating a single defibrillator analyser often requires 5 to 6 different measurement systems, leading to high complexity and inconsistent results across European NMIs. Most countries currently lack primary standards for high-energy impulses and high-frequency power. In this project, a reproducible and applicable system will be established according to IEC 60601-2-4 and IEC 60601-2-2. We will develop traceable High-Voltage (HV) and High-Current (HC) impulse measurement equipment for defibrillators up to 360 J, achieving a target uncertainty of 0.3% for impulse energy. For Electrosurgical Units (ESUs), high-precision broadband generation and measurement capabilities will be optimised up to 1 MHz and 300 W with a 2% power measurement uncertainty. By implementing AI/ML-enabled algorithms for pulse waveform parameter determination, the project will replace manual, error-prone processes with automated, high-accuracy protocols, providing a necessary testbed for device manufacturers to ensure regulatory compliance.

Objective 2: Traceability and reference measurement system for ECGs and EEGs

The safety and accuracy of ECG and EEG devices currently rely on testing methods (IEC 60601-2-25/26) that lack comprehensive uncertainty analysis and often use 40-year-old databases (e.g., CSE database) or oversimplified signals. This project will move beyond these legacy systems by using a JAWS quantum standard for the direct sampling of low-level voltage signals (10 µV to 5 mV). We will develop a metrological traceability route that incorporates modern synthetic and biological ECG/EEG signals, supported by advanced AI/ML tools for noise reduction and realistic simulation. The project will establish validated reference calibration setups that provide higher accuracy in time-domain characteristics and interval analysis (e.g., QT, PR, RR). This ensures that the next generation of simulators is validated against the highest metrological standards, bridging the gap between outdated testing protocols and modern clinical demands.

Objective 3: Traceability for bioimpedance measurements

Traceability in electrical bioimpedance (EBI) is currently poorly established, with existing standards focusing primarily on safety rather than measurement accuracy. Current calibration schemes are often limited to the real axis, failing to account for the complex-plane nature of biological tissues. Met4MED will develop new calibration schemes covering the full complex-plane and provide a thorough estimation of in-use uncertainty, including contact impedance and stray effects. We will establish a new EBI measurement system with metrological accuracy across an extended frequency and magnitude range (up to hundreds of kHz, 10 Ω to 100 kΩ). By characterising the frequency-dependence of the human body impedance network, the project will provide manufacturers with the first widely available, metrologically sound tools to validate device performance and achieve MDR (EU) 2017/745 compliance.

Cross-cutting Innovation: AI-driven Metrology and Open-Source Frameworks

Traditional medical calibration is often periodic and prone to human error. This project introduces a paradigm shift by integrating supervised and deep learning models into the calibration process, enabling dynamic, real-time assessment of sensor deviations and environmental influences. To ensure maximum impact and transparency, all calibration protocols, reference datasets, and software tools will be shared via open-source platforms (e.g., GitHub/GitLab). This approach reduces dependence on proprietary systems, lowers costs for healthcare providers, and fosters a collaborative environment where NMIs, hospitals, and manufacturers can implement traceable and harmonised measurement systems. Ultimately, this open-source metrological framework will accelerate the adoption of innovative medical technologies while ensuring the highest levels of patient safety.

Outcomes and Impact

Outcomes for industrial and other user communities

The Met4MED project will deliver innovative, traceable calibration systems for life-critical devices including defibrillators, electrosurgery units (ESUs), ECG, EEG, and bioimpedance analyzers. By implementing open-source (GitHub and GitLab pipeline) and modular hardware/software solutions, the project will drastically reduce the cost and complexity of medical device calibration. This approach makes advanced measurement techniques accessible to a broader range of industrial stakeholders, particularly Small and Medium-sized Enterprises (SMEs). Manufacturers and healthcare providers will benefit from faster, more cost-effective approval processes by aligning technical documentation with the Medical Devices Regulation (MDR (EU) 2017/745) and relevant IEC standards. Ultimately, these outcomes will ensure that medical equipment performs to the highest specifications, reducing the risk of device recalls and enhancing clinical confidence in equipment used at the patient’s bedside.

Outcomes for the metrology and scientific communities

Current medical metrology infrastructure often lacks the NMI-level capabilities required for high-precision impulse and high-frequency power measurements. Met4MED will strengthen the competitiveness of European National Metrology Institutes (NMIs) and Designated Institutes (DIs) by providing access to advanced calibration infrastructure and robust metrological traceability. The project will establish a reference framework for bioimpedance and complex bioelectrical signals, enabling researchers to benefit from reliable, validated data when developing new therapies. Furthermore, the project will provide a workhorse for evaluating the safety and explicability of AI/ML-based signal processing algorithms. By establishing harmonized best practice guidelines and calibration protocols, the project will increase the consistency and comparability of results between laboratories across Europe, bridging the gap between legacy tools and the demands of modern clinical practice.

Outcomes for relevant standards

Met4MED will provide a vital blueprint for meeting the requirements of the Medical Device Regulation (MDR (EU) 2017/745) through modular and open-source technical documentation. This will facilitate increased reproducibility and safer operation of medical electrical devices. The project’s results will directly support the implementation of the EU Artificial Intelligence Act by ensuring that AI algorithms used in medical measurements are technically robust, reliable, and traceable. Additionally, the dissemination of harmonized calibration protocols will support the update and standardization of relevant IEC and international safety standards. By providing regulatory bodies with consistent, technically sound evidence of performance, Met4MED will facilitate a smoother transition for industry players toward certified, high-standard medical products.

Longer-term economic, social and environmental impacts

The economic and social impact of this project is well aligned with the goals of the United Nations Economic and Social Council that passed E/RES/2021/30 and invited to find “ways to better leverage open-source technologies for sustainable development”. Statista.com webpage states that the projected revenue in the medical devices market in Europe is estimated to reach US $149.58 billion in 2025. Among the various markets, cardiology devices market is the largest, with a projected market volume of US$21.53 billion in 2025. Looking ahead, the market is expected to experience a steady annual growth rate (CAGR 2025-2030) of 4.57 %, resulting in a market volume of US$187.02 billion by 2030. This project will create a MDR (EU)2017/745 blueprint for new innovations in electronic and bioimpedance signal systems helping to keep Europe at the forefront of the medical imaging market.

Socially, the project will significantly improve healthcare quality by reducing medical errors—an underappreciated but avoidable source of patient risk. Accurate calibration reduces the dangers of under-delivery (ineffective therapy) or over-delivery (burns and tissue damage) in critical interventions. Environmentally, the modular and open-source nature of the developed hardware will simplify repair and upgrade processes, extending the lifespan of medical devices and reducing electronic waste, in line with the European Sustainable Products Initiative and the Green Deal.