Medical devices are not all created equal. Some carry more risk than others do, and regulatory bodies across the world classify them accordingly. Class III medical devices fall into the highest-risk category. These devices are often life sustaining, implanted, or used in critical care settings, meaning their failure could result in serious injury or death. Because of this, they are subject to the most rigorous regulatory approval processes.

This article explores what qualifies as a Class III device and the documentation required for regulatory approval in key markets such as the United States (FDA) and the European Union (EU MDR).

What Is a Class III Medical Device?

A Class III medical device defined by its potential risk to the human body. These devices typically:

• Sustain or support life
• Are implanted in the body
• Pose a high risk of harm if they fail

Examples of Class III Devices:

• Implantable pacemakers and defibrillators
• Heart valves
• Deep brain stimulators
• Breast and orthopedically implants
• Intraocular lenses
• Artificial pancreas systems

Such devices cannot be marketed without robust evidence demonstrating safety, clinical performance, and quality manufacturing processes.

How Are Class III Devices Classified?

United States (FDA):

Under Title 21 of the Code of Federal Regulations (CFR), Class III devices require Premarket Approval (PMA) unless they qualify for down-classification and are eligible for the 510(k) pathway under certain conditions.

European Union (EU MDR):

Classification based on Annex VIII of the EU Medical Device Regulation (2017/745). Rule 8 specifically covers active implantable devices and surgically invasive devices intended for long-term use.

Documentation Required for Class III Device Approval

In the United States (FDA – PMA Pathway):

A Premarket Approval (PMA) submission must include:

• Device Description & Intended Use
• Non-Clinical Test Data (biocompatibility, bench testing, electrical safety)
• Clinical Data (IDE studies, Real-World Evidence, Digital Health Technologies)
• Labeling Documents (IFU, package inserts, promotional material)
• Risk Analysis & Benefit-Risk Assessment
• Manufacturing Information
• Summary of Safety and Effectiveness Data (SSED)

As of 2024, the FDA increasingly encourages the use of Real-World Evidence (RWE) and Digital Health Technologies (DHTs) in PMA submissions.

In the European Union (EU MDR – Class III Devices):

Manufacturers must submit Technical Documentation to a Notified Body, including:

• General Device Description
• Design & Manufacturing Information
• Risk Management File (ISO 14971 compliant)
• Clinical Evaluation Report (CER)
• Biological Safety & Biocompatibility Data
• Labeling and Instructions for Use (IFU)
• Post-Market Surveillance (PMS) Plan
• Post-Market Clinical Follow-Up (PMCF) Plan
• Summary of Safety and Clinical Performance (SSCP) – published in EUDAMED

Since May 2021, Class III devices in the EU must also comply with:

• Stricter clinical evidence requirements
• Unique Device Identification (UDI) for traceability

Notified Body review and certification are mandatory for EU market entry.

Conclusion

Class III medical devices provide life-changing benefits to patients but come with the highest regulatory expectations. Whether pursuing FDA approval or CE marking under EU MDR, success depends on well-structured documentation, strong clinical evidence, and strict compliance.

For manufacturers, understanding the classification rules is just the first step. The challenge lies in preparing accurate, comprehensive, and regulator-ready documentation that accelerates approvals and ensures patient safety.

At Maven Regulatory Solutions, we specialize in supporting medical device regulatory submissions, offering expert guidance on PMA documentation, EU MDR compliance, technical files, CER development, and post-market strategies. With our expertise, you can confidently bring Class III devices to global markets.