Medical Device Labeling Regulations

Medical Device Labeling - Understanding the Regulations


To ensure compliance in your medical device labels and meet UDI requirements

Medical Device Labeling White Paper
Medical Device Labeling White Paper

Recent changes in regulations to medical device labeling make it critical that manufacturers are up-to-date on the requirements for compliance. A rising demand for better consumer safety and clearer communication has driven both the United States and the European Union to undertake significant overhauls to their regulations. Medical device labeling is a more complicated topic than most other product labeling, as the definition of what constitutes a medical device is tremendously broad. This means that regulations in every country have a lengthy list of caveats depending on the precise purpose and construction of the device, but the core requirements are the same and focus on instructions for use and identification.

Along with compliance, ensuring consumer safety is imperative in communicating label information in the event of a recall. A centralized registry of information on medical devices currently on the market also makes conducting recalls much easier. It is important, therefore, to ensure that each label is properly printed and applied to every medical device on the production line. Using a vision inspection system to verify the presence and accuracy of your labels can be part of a comprehensive quality assurance program in medical device labeling.

Learn more about medical device labeling requirements, including the following:

  • Unique Device Identifier (UDI) requirements
  • Differences between the US, EU and China regulations
  • Requirements for label content and label definitions
  • Overview on the differences between class I, II and III devices

Download this informative white paper to learn more

This white paper explores the labeling requirements for medical devices in the United States, the European Union, and China. Each territory has its own particular set of regulations governing the labeling of medical devices, and while there are a certain amount of commonalities in each of the regulations, there are differences which necessitate care from global manufacturers when distributing products.

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