According to the "Medizinproduktegesetz" (the German version of the European Medical Device Directive), PTB is to ensure uniformity in the field of medical measurements.
www.linguee.de/englisch-deutsch/uebersetzung/european+medical+directive.htm
emed and pedar systems are certified medical products following the MDD 93/42.
The certification is indispensible for the use of the system as a diagnsotic diagnostic instrument in medicine.
Tests are performed for each series by the notified body TUEV Vienna TÜV Austria.
During the certification of the singular pedar systems the quality of their measuring function was tested. It was found that the deviation of the average pressure was lower than 2.5 % at different pressure levels. The accuracy of the sensor area was found to be higher than 99.73 %, which is essential for the calculation of the correct force values, loading the sensor insole.


