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Medical Device Labeling

Overview

Overview

Medical device labeling forms a critical part of any device. It provides information to the consumer in textual or graphic forms on the packaging with an intent to increase the safety and usage instructions for the consumers. 

Globally, misbranding and mislabeling have increased the medical device recall rate by 15%. According to the latest consensus, devices with 510k approval account for 71% of high-risk recalls. It indicates an alarming snapshot of the industry’s quality issues and a potential threat to public health. Soaring recalls lead to serious long-term reputational and financial damage. Between 2017 and 2019, 5.9% of the device recalls were attributed to mislabeling. Nearly 4,500 devices are pulled down by the US FDA annually. 

Freyr’s medical device experts are relentlessly engaged in providing end-to-end labeling services throughout the device’s life cycle. We analyze, review, track, update, and maintain label changes for device manufacturers and provide labeling solutions right from device conceptualization to final artwork publication. 

Freyr Expertise and Advantages
Expertise

Freyr Expertise

  • Global medical device labeling strategy
  • Labeling content strategy
  • Creation, remediation, and maintenance of all label components throughout the lifecycle of the device
  • Quality management system (QMS) throughout the life cycle of the device
  • Prepare and maintain reference safety information and patient guides in multiple languages
  • Gap analysis for premature labels and updating existing labels as per the country’s Regulatory demands
  • Align with the latest 21 CFR 801 and EU MDR regulatory guidelines
  • Align with EU MDR Labeling and IVDR labeling compliance
  • Customizing data from primary to secondary labels
  • IFU labeling in multiple languages  
  • Provision for E labeling (eIFU)
  • UDI compliance includes the provision of UDI labeling requirements (Unique Device Identification)
  • Usage of internationally recognized symbols

Ensuring your end-to-end labeling compliance

  • As experts, we take great care in curating the best service for our customers in MDR labeling requirements
  • Our experts cater unique, customized, and eco-friendly labels for your medical device labeling requirements
    • Our exceptional approach and short lead times allow our customers to have the necessary workability
    • We recognize and act based on the ever-evolving global medical device labeling requirements and medical device label compliance, further reducing recalls and costs
  • We ensure the privacy, security, and audibility of your data during medical device packaging and labeling.
  • Unify all the data