Change up ahead: How medical device manufacturers can prepare for new regulations

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Change up ahead: How medical device manufacturers can prepare for new regulations

November 27, 2020
Bob Tilling
By Bob Tilling

The deadline for the new EU Medical Device Regulation (EU MDR), which demands identification and traceability on all medical device labels sold on the EU market, has been pushed back to 2021 – but this does not mean that medical device manufacturers should ignore the regulation until then. The stringent new measures will require much more from manufacturers than manual labeling processes and in some cases, a complete overhaul of processes will be needed. Those who are prepared for the new regulation and streamline processes ahead of next year will reap the rewards for future regulatory changes.

The upcoming EU MDR regulation means stricter regulations for labels on medical devices sold and used in the EU – and this new regulation will affect manufacturers of medical devices worldwide. With the widespread business disruption that has dominated a large portion of 2020, the delay of this regulation until 2021 will be welcomed by many – but preparations for the new measures should not be delayed. Medical device manufacturers that currently rely on manual labeling processes will struggle to comply with the new regulations if they do not allow ample time to revamp and streamline processes ahead of the implementation.

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Manual labeling is not sufficient for upcoming regulation
The medical device industry has enjoyed more relaxed controls over device identification and traceability, and product lifecycle monitoring and reporting, in comparison with the adjacent pharmaceutical and biotech industries. This, added to the relative size and scale of many of the firms involved, has meant processes such as global labeling management have previously not been viewed as a board-level priority.

Manual label processes are common in medical device manufacturing and are often printed from ERP systems on the factory floor and added to medical devices. Instructions for use (IFU) and other customer-facing materials are managed by separate teams and sometimes even outsourced to design agencies. This siloed approach to labeling will not be robust enough to meet the new EU regulations. The new measures require systematic coordination and uniformity – many manufacturers will need to streamline and automate labeling processes to ensure labeling is consistent, efficient and, more importantly, compliant. Here are four challenges manufacturers must address ahead of the upcoming EU MDR and how enterprise-grade, automated labeling solutions will play a key role.

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