Last week, medical device manufacturers from across the U.S. came together to discuss the constantly changing world of labeling at Q1 Productions’ 6th Semi-Annual Medical Device Packaging and Labeling Summit.
While abiding by FDA labeling requirements presents ongoing challenges for these companies, topics like localization and translation also dominated much of the agenda. This group is always candid and open in sharing their experiences which makes for some great conversation!
Here are a few takeaways from the event.
Country-specific labeling rules are evolving – With medical devices being shipped across the globe, it is important for labelers to understand how regulations in each country impact their labeling and packaging. With EU MDR & IVDR being published in the coming weeks and country-specific requirements in Asian markets, there is much to consider to ensure compliance.
It takes a team – Implementing a global labeling strategy is no small feat. While ownership often falls on the labeling team, the regulatory, R&D, operations, and quality departments are heavily involved. One presenter shared the importance of “getting everybody on board”. The more the labeling team can help its constituents understand the what and the why of the regulation, requirements and implementation, the more successful the compliance effort will be.
Never a dull moment – Regulations are constantly evolving and the FDA announced two new rules last year that have medical device manufacturers evaluating their labeling processes. The Human Factors Usability Testing Guidance and the rule on the Use of Symbols in Labeling introduce new requirements. Companies will need to work quickly to understand the new rules and apply labeling strategies to comply.
If you’re looking to better understand the UDI compliance process, check out our Guide to UDI Compliance.
NiceLabel will be at the upcoming UDI Conference, June 7-8 in Baltimore and Q1 Productions’ Medical Device Packaging and Labeling Summit, June 26-27, in San Jose. We hope to see you there!