Medical Device Labeling: Regulatory Requirements for Medical Device Manufacturers

Medical device manufacturers spend considerable resources to research and develop products used by medical professionals and consumers in the market. And due to the criticality of these products as it relates to the health and safety of the end consumer, these manufacturers must ensure that products meet the necessary quality and regulatory standards.

Medical device labeling is also a key element of manufacturers' efforts to comply with the standards and regulations instituted by relevant regulatory bodies including the U.S Food and Drug Administration (FDA) and the European Union’s Medical Device Regulation (MDR).

Ensuring medical devices and related products are accurately labeled is critical for traceability and enables businesses to more easily remove specific products from circulation in the market in the event of a recall.

Offering products without the required and appropriate medical device labels can result in undesired consequences because faulty or defective products are prone to causing injury or death for the end consumer. Additionally, compliance and regulatory bodies can also take legal action against the manufacturer resulting in massive fines and reputational damage.

This concise guide explores medical device labeling and the details manufacturers must include on labels when assembling and packaging their products.

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For proper and comprehensive compliance and safety, regulators define parameters and factors manufacturers should follow when making medical device products. As such, medical devices can be defined differently depending on the regulators’ jurisdiction.

In the U.S., the FDA defines a medical device as an instrument, apparatus, implement, machine, or related item intended for application in disease diagnosis, prevention, cure, and mitigation in humans and animals.

The European Union takes a similar line when classifying a medical device. The MDR defines it as an instrument, apparatus, appliance, software, implant, reagent, or another article primarily used for diagnosing, monitoring, preventing, treating, or alleviating diseases, disabilities, injuries, and other physiological and pathological states.

And like its American counterpart, the MDR insists that medical devices should affect their primary purpose without pharmacological, immunological, or metabolic means in or on the human body.

Medical device labeling refers to information and details attached to products by manufacturers. These details include symbols, instructions, warnings, as well as control information. Medical manufacturers label devices by printing, machining, coding, and molding.

Governmental and institutional organizations require manufacturers to provide comprehensive information about the product to the user to ensure and maintain safety for the consumer.

And to ensure that manufacturers append the correct and necessary information to the product, the US FDA and EU MDR issue regulations for labeling medical devices. For instance, manufacturers must follow specific rules regarding label size, placement, and product information.

Labeling medical devices is essential for both the manufacturer and the consumer. Some of the key reasons these labels are so important include:

Safety: Patients and medical personnel often need instructions to guide them through using the product or device.

For example, many individuals own epinephrine pens to deliver adrenaline in the case of an allergic reaction. The manufacturers of these devices must attach instructions on how to use the pen in case of an emergency.

Additionally, the manufacturer’s label must show how the patient or caregiver should handle the pen during storage and other functions. For instance, a label should indicate if the pen should be kept at a specific temperature to ensure that the medical agent within it still affects patients as intended.

All this avoids potential patient danger ranging from minor allergic reactions to a variety of life-threatening conditions.

Compliance: Regulatory bodies require manufacturers to label medical devices and related products properly. Proper labeling shows these organizations that the company complies with the set guidelines.

In the US, medical device labeling requirements are outlined in 21 CFR Part 801, specifying the minimum requirements for all devices. These requirements can include label placement and prominence, what types of information must be included on containers and outside labels, adequate instructions for use, servicing instructions, as well as prescription device requirements.

Additionally, there are a number of other requirements that manufacturers may need to meet depending on the specific category of device.

Manufacturer identification: Both EU and US medical device labeling regulations require the inclusion of various manufacturer information on the device label to ensure traceability and accountability. These details will vary by jurisdiction (country, region, etc.)

In the US, the FDA stipulates that a label must be present on the immediate container and additional packaging on the item. This means manufacturers are also expected to append labels to brochures, inserts, booklets, and other articles accompanying the product when it’s presented to the market.

The FDA’s general labeling requirements are stipulated in CFR Title 21 Part 801. Per the stipulations:

• Medical device labels in the U.S. must show the name and location of the business

• The label shows the intended device use

• Adequate instructions for the ordinary person to use the item safely

• The label must be prominently displayed

• The label should have Unique Device Identifiers (UDI) for track and trace purposes

The European device label regulations, detailed in Annex I Chapter III of the EU MDR, align with the FDA’s requirements. However, the EU also requires manufacturers to add updated medical device label information on the company’s website.

Because of the purpose that labeling serves as it relates to safety and compliance, it is crucial that manufacturers are able to consistently and accurately label their products in accordance with the established guidelines.

Using Tulip, medical device manufacturers are able to streamline their product labeling and packaging process by integrating data from their system with label printers.

By leveraging the system(s) responsible for guiding production processes, manufacturers are able to reduce errors resulting from manual human input and ensure the accuracy of label details. This allows businesses and regulators to improve product traceability, making compliance a seamless part of their production and packaging processes.

If you’re interested in learning how you can implement Tulip to optimize your quality and compliance initiatives, please feel free to reach out to a member of our team today!