Track & Trace | Serialization | Aggregation - tailor-made complete solutions for medical technology
FAKTEN:
39% of all counterfeits endanger life and limb of the patient
Increasing the risk of counterfeiting through 3D printing
According to estimates by the WHO, WORLDWIDE 8% of the products sold are counterfeits
SITUATION:
UNIQUE DEVICE IDENTIFICATION (UDI) is an identification system for worldwide market surveillance and traceability of medical devices. It aims to help prevent product counterfeiting, simplify product recalls and increase patient safety.
In the future, every medical device will be assigned an identification number and with further information on the respective product will be stored in a global database (GUDID). Authorities and facilities in the healthcare sector can access this data at any time via generally accessible interfaces.
The European UDI guidelines became effective with the Medical Device Regulation (MDR) of the EU on May 26th, 2017. Three years later, from May 26th, 2020, they must be applied in Europe