ABSTRACT
The Global Harmonization Task Force has issued guidance on unique device identification (UDI) which implores countries to consider the Global Harmonization Task Force guidance in promulgating regulations on UDI. For most medical devices, the label on the product is the primary interface between the user and the product. Whether e-labeling alone is accepted is an entirely different matter and will likely be increasingly permitted over time. But all labeling must be based on the risk management performed by the manufacturer during design and development, no exceptions. Clinical evaluation and investigation are the tool to validate critical labeling content, for example, under what conditions the device should be used, what performance specifications may be expected, what precautions need to be taken. One of the more critical aspects of the labeling content is the language. The use of a language other than the native languages is in most countries of the world restricted to higher professional users or specialists.
