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Medical devices are not all created equal. Some carry more risk than others, and regulatory bodies across the world classify them accordingly. Among these, Class III medical devices fall into the highest-risk category. These are devices that are often life-sustaining, implanted, or used in critical care settings. Because of their potential impact on patient safety, Class III devices are subject to the most rigorous regulatory requirements.
In this article, we break down what qualifies as a Class III device and what documentation is needed to obtain approval in key markets like the U.S. and the EU.
What is a Class III Medical Device?
A Class III medical device is 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 injury or death if they fail
Examples of Class III Devices:
- Implantable pacemakers and defibrillators
- Heart valves
- Deep brain stimulators
- Breast or orthopaedic implants
- Intraocular lenses
- Artificial pancreas systems
These devices cannot be marketed without robust evidence demonstrating their safety, clinical performance, and manufacturing quality.
How are Class III Devices Classified?
Each regulatory region has its own classification framework:
- United States (FDA): Devices are classified under Title 21 of the Code of Federal Regulations (CFR). Class III devices require a 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 is based on Annex VIII of the Medical Device Regulation (EU) 2017/745, with Rule 8 specifically covering active implantable devices and surgically invasive devices intended for long-term use.
What Documents are Required for Class III Device Approval?
Approval for a Class III medical device requires extensive documentation, which varies depending on the regulatory pathway.
In the United States (FDA - PMA Pathway):
A Premarket Approval (PMA) submission must include the following components:
- Device Description & Intended Use
- Non-Clinical Test Data (e.g., biocompatibility, bench testing, electrical safety)
- Clinical Data (e.g., results from Investigational Device Exemption (IDE) studies or Real-World Evidence (RWE))
- Labelling (Instructions for Use, package inserts, promotional materials)
- Risk Analysis & Benefit-Risk Assessment
- Manufacturing Information
- Summary of Safety and Effectiveness Data (SSED)
As of 2024, the FDA continues to encourage the use of Real-World Evidence (RWE) and Digital Health Technologies (DHTs) in support of PMA submissions, particularly for post-market data.
This documentation must demonstrate that the device is safe and effective for its intended use, with sufficient evidence from well-controlled clinical investigations.
In the European Union (EU MDR – Class III Requirements):
Manufacturers must submit a comprehensive Technical Documentation File to a Notified Body, including:
- General Device Description
- Design and Manufacturing Information
- Risk Management File (in accordance with ISO 14971)
- Clinical Evaluation Report (CER) based on existing clinical data or new clinical investigations.
- Biological Safety & Biocompatibility Data
- Labelling and Instructions for Use (IFU)
- Post-Market Surveillance Plan & Post-Market Clinical Follow-Up (PMCF) Plan
- Summary of Safety and Clinical Performance (SSCP), which must be made publicly available
Since May 2021, under Regulation (EU) 2017/745, Class III devices must also comply with stricter clinical evidence requirements and Unique Device Identification (UDI) rules.
Additionally, the Notified Body is also required to submit the SSCP to EUDAMED for public access.
Notified body review and certification are mandatory for EU market access.
Conclusion
Class III medical devices offer life-changing and often life-saving benefits to patients. However, with high impact comes high responsibility. Whether you’re seeking FDA approval or CE marking under the EU MDR, successfully navigating the documentation landscape is critical.
Understanding what qualifies a device Class III is just the first step. Ensuring your documentation is accurate, evidence-based, and aligned with regulatory expectations ultimately determines how quickly your device reaches the market.
Our expert medical writing team is here to help you navigate the complexities of documentation with clarity, compliance, and confidence. Explore our medical writing services for medical devices by clicking here.
