Track & Trace | Serialization | Aggregation
turnkey solutions for medical devices
FACTS:
39% of all counterfeits endanger life and limb of the patient
Increased risk of counterfeiting through 3-D printing
WORLDWIDE, according to WHO estimates, 8% of products sold are counterfeit.
SITUATION:
UNIQUE DEVICE IDENTIFICATION (UDI) is an identification system for worldwide market surveillance and traceability of medical devices. It is intended to help prevent product counterfeiting, simplify product recalls and increase patient safety.
In future, each medical device will be assigned an identification number and stored in a global database (GUDID) with further information on the respective product.
Public authorities and healthcare institutions 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 26 May 2017. Three years later, from 26.05.2020, they must be applied in Europe.