Sophia Rubalcaba, Sr. Regulatory & Quality Project Director
What is medical device labeling? In general, labeling is considered to be all labels and/or other written, printed, or graphic information placed directly on the device, the device packaging (e.g. containers or wrappers), or its accompanying device information. While advertising materials may also be encompassed within device labeling, it is outside the scope of the present discussion.
Implementation of best practices is critical to managing device labeling complexity. The following outlines areas to be considered to facilitate development and implementation of appropriate medical device labeling.
Specifications must be defined and documented within the medical device design history file. Defining and integrating labeling needs early in the product development process is important to avoid issues leading to product redesign. This is particularly critical for devices which require direct marking to comply with Unique Device Identification (UDI) requirements or in the final device packaging configuration for sterile devices. The final package configuration must be designed to allow for placement of other information or accompanying materials packaged with the device (e.g. instructions for use). Product, package and labeling materials must remain affixed, be indelible and compatible with manufacturing processes (i.e. sterilization, shipping of product, etc.).
Integrating labeling requirements early will ensure appropriate selection of product materials, packaging configurations, and sufficient labeling space is integrated into the product design. It further ensures evaluation of the labeling is captured within product testing needed to support device applications for marketing.
Understand The Regulatory Requirements Where The Product Is To Be Marketed
The actual definition of medical device labeling and the content of the labeling may vary and is defined in specific regional, state or country specific regulations (e.g. United States Food and Drug Administration, European Medical Device Directive, etc.). One of the most challenging requirements device manufactures must contend with is the implementation of labeling to address multiple country specific language requirements. This may be further complicated by regional or state requirements that may impose additional regulations with regard to labeling content or information which must be incorporated within the labeling (e.g. contact information, language translation, environmental labeling, product disposal, etc.).
Knowing where the product will be marketed, reviewing market specific regulations and harmonizing label content (i.e. product information, symbols, UDI, language requirements, safety information, etc.) facilitates labeling management and compliance with regulations.
Know The Product Specific Labeling Requirements
In addition to meeting country regulatory agency requirements, certain devices require additional product specific labeling to be included with the product (e.g. other informational literature) or that the existing labeling include added informative content (e.g. performance testing, and/or specific tolerances or prohibitions on certain ingredients). Devices containing specific compounds or components (e.g. rubber or latex) require specific labeling content and precautions. Further, the type of device may also dictate the type of label or label content. For example, medical electrical devices impose additional labeling requirements for adherence of labels directly on the device and information to be included within the product labels, the package labeling, and other accompanying device materials.
Understanding product specific labeling requirements is necessary to ensure appropriate content and applicable labeling compliance.
Development of Labeling Systems and Procedures
Medical device manufacturers are required to incorporate elements related to product labeling into their quality systems. In addition to labeling specifications in the design history file, procedures establishing appropriate purchase, receipt, use, storage, attachment (including area separation), inspection, control, traceability, retention and change control of labels must be established and put in place. The quality system procedures should also address control of equipment and materials used to generate or print labeling materials. These requirements must be demonstrated whether product labeling (printing or attachment) is done in house or outsourced.
Procedures should be strategically defined and established for compliance to quality system requirements while allowing flexibility for change and capacity.
In summary, medical device labeling is a complicated undertaking. Manufacturers spend a great deal of economic and human resources to ensure medical device labeling compliance. This is evidenced by the fact that many device manufacturers dedicate entire departments or groups focused on the development, implementation and management of labeling. Establishing best labeling practices early and efficiently is critical to its successful implementation.
RCRI consultants are available to help you develop your labeling strategy. To be put in touch with an RCRI expert, contact Samantha Spence at firstname.lastname@example.org or 952-224-2260.
BS EN ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory
IEC 60601-1:2005+A1:2012(E) Medical electrical equipment – Part 1: General requirements for basic safety and essential performance