Metrology for medical electrical devices

The Medical Device directive 2017/ 745 aims to provide a smooth European market for medical device manufacturers whilst ensuring the protection of both the patient and the user. Although all hospitals and manufacturers must perform periodic equipment testing, very few measurement systems currently have comparable calibration methods or SI-traceability. This includes regularly used instruments such as Electrocardiography (ECG) and Electroencephalography (EEG) units that measure the activity of the heart and brain, or electrical bioimpedance (EBI) analysers that use electrical impedance to measure body composition such as fat percentage and muscle mass. For heart defibrillator analysers – where SI-traceability does exist - up to five or six different measurement standards must be used, leading to complex calibration paths.

This project will develop a validated reference measurement system to allow the traceable calibration of EEG and ECG simulators. The human body’s “impedance network” will be characterised allowing measurement traceability to be established for EBI instruments. Machine Learning and AI approaches will also be developed to improve the accuracy of dissolved blood gases, biochemistry, and haematology monitors allowing large volumes of data to be analysed to determine the calibration needs of these instruments in real-time.

The results of Met4Med will establish advanced calibration and measurement techniques accessible to even the smallest medical device developer, strengthening European competitiveness in this area. At the same time, it will also contribute to better patient outcomes and increase confidence in these types of medical technologies.