4 Major Class II Medical Device Requirements

Many growing startups and scale-ups deal with non-compliance issues at one point or another.

Unfortunately, failure to meet major medical device requirements will bring the production of your product to a screeching halt. In some cases, non-compliance may even result in steep fines, penalties — or even worse. 

Fortunately, the FDA clearly outlines the unique requirements that your device must meet based on its classification. In general, Class II requirements are not as stringent as Class III requirements. However, there are a few areas that will require your undivided attention.

To date, Qualio has helped hundreds of medical device organizations comply with the latest FDA laws and regulations. In this article, we’ve compiled a list of the most important Class II medical device requirements that will have the most significant impact on achieving FDA clearance.

Top 4 Class II Medical Device Requirements for Life Sciences

Before we begin, what are the major differences in medical device classes?

Class II medical devices typically pose a high risk to the patient or user. In general, these devices pose less potential harm than Class III medical devices but more than Class I devices. Most devices on the market today fall into this unique category.

According to the FDA Premarket Notification 510(k) Guidelines, medical device organizations must “demonstrate that the device to be marketed is safe and effective, that is, substantially equivalent, to a legally marketed device.”

Beyond adhering to these guiding principles, here is a comprehensive list of Class II medical device requirements for life sciences organizations.

1. Labeling (21 CFR Part 801)

The 21 CFR Part 801 requirement defines labeling as a display of any “written, printed, or graphic matter upon the immediate container” of any Class II medical device. These labels must be legible and easily identifiable.

Additionally, the regulation includes guidelines for any advertising “written, printed or graphic matter” for Class II medical devices. This regulation also covers any paper-based wording on posters, tags, pamphlets, booklets, brochures, instructions, direction sheets, or packaging included with the Class II medical device. 

To find specific standards for medical device labeling based on your unique product type, reference Title 21 of the Code of Federal Regulations.

2. Procedures for Performance Standards Development (21 CFR Part 861) 

The 21 CFR Part 861 requirement states that Class II medical device manufacturers must demonstrate “reasonable assurance of the safety and effectiveness of the device.” 

As such, the device must undergo rigorous performance and procedural testing. These test results must display compliance and conformity with all relevant and applicable requirements.

In carrying out effective performance and safety testing, the FDA routinely leverages the expertise of recognized national and international entities, as well as representatives from scientific and consumer organizations. 

What’s more, the FDA establishes standards advisory committees to oversee the establishment, management of major laws and regulations applicable to all medical device classes.

3. Medical Device Reporting (21 CFR Part 803)

The 21 CFR Part 803 requirement mandates that all incidents involving Class II medical devices that have caused or contributed to a death or serious injury must be reported promptly. These records must be submitted within 10 days of the occurrence. While uncommon, failure to report these issues could lead to major penalties or even complete suspension.

Manufacturing facilities are not required to report incidents to the FDA. However, they are encouraged to do so through MedWatch. 

MedWatch is a voluntary safety reporting program purpose-built for consumers and health professionals. By sharing major incident reports, industry professionals are able to stay on top of current and ongoing health and safety issues.

4. Quality System Regulation (21 CFR Part 820)

Today, the FDA requires that all medical device manufacturers establish mission-critical processes and procedures to consistently meet all applicable laws and regulations. 

The 21 CFR Part 820 requirement outlines the unique methods, controls, and systems for “designing, purchasing, manufacturing, packaging, storing, and installing and servicing medical devices.”

As such, developing and maintaining an electronic quality management system (eQMS) is crucial for proving Class II medical device effectiveness.

From document management to audit-ready reporting, Qualio offers a complete and best-in-class solution designed to meet the unique requirements of all medical device classes. Additionally, we’ve supported some of the world's leading pharmaceutical, biotech, and contract service providers, including Linical, Cirris, and ArcScan.

How to Ensure Your Medical Device Meets Class II Requirements

To achieve rapid Class II medical device compliance, we recommend instituting controls for handling and servicing your medical device in conjunction with .

As a suggested next step, we recommend auditing the effectiveness of your current QMS. Qualio offers all the features you would expect from an industry-leading QMS—including document management, training, design control, events, and reporting. We are routinely rated as one of the top QMS solutions among growing medical device and biopharmaceutical startups and scale-ups. 

If you’re considering migrating away from a paper-based quality system, consult our free guide: How to Migrate from a Paper-Based System to QMS Software. Read it to learn how to ensure a smooth and seamless transition in three simple steps.