All medical devices sold must adhere to medical device labeling standards set forth by the FDA and other regulatory bodies. Labeling is provided for the end-user to consult, as well as other individuals in the manufacturing process.
Labeling is a broad term that encompasses any written, printed or graphic matter on or included with the device or the packaging. Medical device labeling symbols, warnings, information displayed on a user interface (UI), and documentation are all considered “labeling” by ISO 13485.
Overall, device labeling provides patients and medical practitioners alike with instructions on proper device use, as well as any potential risks.
Every step in the medical device production process comes with a strict set of standards and specific requirements. That includes labeling requirements per:
- FDA Code of Federal Regulations (CFR) 21, Part 801
- Canadian Medical Device Regulations, clause 21
- European Union Medical Device Directive Annex 1, clause 13 (though the EU will be changing its medical device directive)
- IEC 60601-1, clause 7
- And more
These medical device labeling standards and regulations are created to ensure that the target users are able to accurately interpret the proper use of the device.
Part 1: General Requirements
While each of these regulatory bodies have slightly different standards, there are general medical device labeling requirements that apply in almost all cases.
This list provides a general overview for what nearly all regulatory agencies require during the medical device labeling process:
- Identification: the medical device must be labeled based on make, model number, date of manufacture and batch or serial number. It must also include a unique device identifier (UDI) under FDA and EU MDR guidelines.
- Contents: the container that contains the medical device must list everything that is supplied with the device.
- Symbols: use medical device labeling symbols as much as possible. Many relevant symbols used in labeling are listed in iso 15223-1.
- Contact Information: Contact information is to be supplied with the container for the manufacturer of the device.
- Label Storage: Labels must be stored in a highly organized manner in order to prevent possible mix-ups.
- Label Integrity: Any device label must be able to withstand regular cleaning (including potentially being sterilized using irradiation or other applicable method) and remain legible over the course of normal use.
- Correct Use: The most important and ubiquitous rule for device labeling is that instructions for correct use must be supplied with the device, including correct medical devices symbols and warnings.
Each region will have varying standards that must be met prior to an official inspection. For example, the U.S. Food and Drug Administration (FDA) has specific medical device labeling requirements that apply to all devices sold within the U.S, however these same regulations may not apply in the E.U.
Part 2: Medical Device Labeling Standard Process
The process of developing a medical device’s labeling should coincide with the development of the device itself and the manufacturer’s planning process.
This prevents unforeseen problems like insufficient space for the label, poor labeling materials, mislabeling, and other problems that will ultimately lead to the device being rejected.
A primary concern in the labeling process is that the final label will withstand shipping, manufacturing, and normal use. For this reason, the labels materials, ink, and adhesives must be tested for integrity throughout the development and verification process.
In addition to a label’s instructional value, a device’s label must meet traceability requirements.
Finally, it’s imperative that the correct labels are applied to their respective devices. For this reason, the device history record should be updated with each batch of products to ensure that a label is not used twice or forgotten.
Use RBC Medical For Comprehensive Device Labeling
At RBC Medical Innovations, we have produced high-quality, regulation-compliant medical devices since 1994.
We understand the importance of medical device labeling, and we keep up with the developing regulatory standards (such as the changes to the MDR in the EU) to ensure that your device is pushed through the testing and acceptance process as fast as possible, getting your product to market sooner.
We do this by integrating device labeling as a component of our end-to-end design process. This ensures that the label will adequately describe proper use of the device, be properly mounted, and meet all regulations set forth by the FDA and other regulatory bodies.
Contact RBC medical today and see why over 93% of our customers select us as their preferred partner for future development projects.