Solutions > Regulatory > EU MDR
With the next major milestone for EU MDR (Medical Device Regulation) quickly approaching, medical device companies need to reassess their label and packaging artwork processes to ensure compliance. Whether a large global company with international reach or a smaller manufacturer in medical device market, these pending changes will have major implications for your business.
Estimated Go Live for EU Database for Medical Devices (EUDAMED)
Date of application of EU MDR
Date of application of IVDR (In Vitro Diagnostic Medical Device Regulation)
Notified Body certificates issued under MDD designation become void
End of the transition coming for the few final devices
European Union’s Medical Device Regulation (EU MDR) is clearly a priority for everyone in the medical device industry. As many of you know the enforcement of the first milestone takes effect on May 2020. As the deadline approaches, manufacturers and suppliers are forced to comply with pending changes quickly or be faced with major implications for their business.
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Loftware Spectrum® for Medical Device redefines how enterprises create, manage and print labels, enabling medical device manufacturers of all sizes to meet rigorous regulatory requirements as they seamlessly implement, deploy, maintain and scale their labeling operations globally.
Learn More →Ultimately, when it comes to managing medical device labeling, you’ll want a solution that enables compliance with EU MDR, FDA UDI and 21 CFR Part 11 regulations and supports validated environments. With Loftware, you’re able to keep pace with EU MDR, and quickly expand use for any evolving regional and international regulations.
