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Why New Medical Device Regulations Require More Than Ad-Hoc Manual Processes

Originally intended to come into force this year in 2020, the implementation date of the new EU Medical Device Regulation (EU MDR) has now been extended to 2021. Under the new regulation, identification and traceability measures will be compulsory for all medical device labeling in the EU market.


The demands of the new regulation highlight some flaws within manual labeling processes and, for some manufacturers, could require a complete overhaul of global labeling management operations. Here, Bob Tilling (VP Global Sales), explains that streamlining labeling processes now will ensure businesses are compliant with the new regulations and are prepared for future regulatory changes as they happen. This time around, products really do have to ‘do what they say on the tin’!