New Medical Device Regulations Require More Than Ad-Hoc Manual Processes (EU MDR)
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’!
The only way to ensure consistency and reliability across all channels and markets is to digitize the labeling process and have a single source of labeling ‘truth’ that all market-facing product information and materials flow from. In other words, one definitive place to update and check everything – which any authorized team can access, anywhere in the world, supported by appropriate controls governing who can do what to and with the content assets.