The EU Medical Device Regulation (MDR 2017/745) has fundamentally reshaped how Class I medical devices are labeled and tracked. One of the most overlooked – yet critical – areas of compliance is the UDI Carrier Label . As of 26 May 2025 , all Class I devices must display a UDI (Unique Device Identifier) on their labels and higher packaging levels. But here's the catch: many small or craft-scale manufacturers are unaware , overwhelmed, or misinformed about what this actually