Should My Class I Device Have Design Controls?

Design controls are a set of processes and procedures that are used to ensure the safety and effectiveness of medical devices. They are an essential part of a quality management system (QMS) and are required by the Medical Devices Regulation (MDR) for certain classes of medical devices.

In the United States, medical devices are regulated by the Food and Drug Administration (FDA) under the authority of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FD&C Act requires that all medical devices, including Class I devices, be designed, and manufactured in accordance with current good manufacturing practice (cGMP).

GMP regulations for medical devices (21 CFR Part 820) require manufacturers to have a quality system in place that includes design controls. Design controls are defined as “the measures that are used to ensure that the design and development of a device are appropriate, and that the device will be safe and effective.”

Therefore, Class I devices must have design controls in place to ensure that they meet the requirements of the FD&C Act and cGMP regulations.

Class I medical devices are generally considered to be low-risk devices and are subject to the least amount of regulatory oversight. However, even Class I devices can pose risks to patients if they are not designed and manufactured properly. Therefore, it is still important for manufacturers of Class I devices to have design controls in place to ensure that their products are safe and effective.
Some of the benefits of having design controls in place for Class I devices include:

  1. Ensuring that the device meets the intended performance and safety requirements
  2. Identifying and addressing any potential design problems early in the development process
  3. Demonstrating to regulatory authorities that the device meets the necessary requirements
  4. Ensuring that the device can be used safely and effectively by the intended users
  5. Facilitating the development of a consistent and high-quality product

Don’t gloss over the importance of design controls even if you are developing a Class I device. They exist to ensure you are delivering a product that is safe and effective to your customers.