Already since 2013 the UDI-Guideline (Unique Device Identification) of the FDA has the validity on the American market. This year the European Parliament has passed a MDR-Guideline (Medical Device Regulation) which is quite similar to the one from the FDA.
This guideline will become a law in the EU and will therefore be mandatory valid for all manufacturers.
STEMA is ready for UDI
Also we are facing the requirements which have surrendered through extensive alterations of the medical product law. One part of these alterations will be affecting the product identification.
We already took appropriate measures and we are glad to inform you that STEMA Medizintechnik GmbH
from now on will be able to make the product identification within the UDI-System through a data matrix
If this will be of interest for you please kindly contact us.