With a predicted value of USD $182 billion in 2024, United States (U.S.) market expansion can provide millions of new customers access to life changing medical device technology. (1) While both the European Union (EU) and U.S. markets are highly regulated, there are important differences in medical device compliance which must be considered before taking the plunge. Understanding these three core regulatory contrasts can make the difference in the success of your market entry.

1. Medical Devices Classification

While both the U.S. and EU device classes are based on risk, U.S. Food and Drug Administration (FDA) and EU requirements are not the same. The classification rules are detailed in the EU medical device regulation, the European Medical Device Regulation 2017/745 (EU MDR). EU medical device classification includes four risk groups (2):

• Class I - Low-risk, non-invasive devices.
• Class IIa - Low to medium risk devices.
• Class IIb - More complex than Class IIa, these devices are medium to high risk.
• Class III - High-risk devices (or software).

While the FDA’s Code of Federal Regulations (CFR) is similar to the MDR medical device regulation, there are some important differences. The FDA medical device classification includes three classes (3):

• Class I - Low-risk devices.
• Class II - Moderate risk.
• Class III – High-risk devices.

For both markets one must understand the device risks and clearly explain the intended use to get the classification right. Going through the device classification process highlights how important medical device compliance with the MDR medical device regulation and the U.S. FDA CFR is.

2. Medical Devices Clinical Requirements

One of the main differences between the EU medical device regulation and the FDA is that a clinical evaluation must be performed for all medical devices, no matter the class. As risk increases, so do requirements.

Clinical evaluation does not always mean clinical investigations. In the EU for lower risk devices, the manufacturer can assess existing data on their device and equivalent devices to check safety and performance following the rules set by the EU medical device regulation. (4)

Higher risk devices do require clinical investigations (tests on humans) in both markets. Often manufacturers look to International Standards Organization (ISO) standards for medical devices to ensure compliance. The primary ISO standard for medical devices is ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes, but ISO 14155 Clinical investigation of medical devices for human subjects, Good clinical practice (GCP) applies to clinical trials.

The FDA does not require clinical trials for Class I devices. (5) Some Class II devices require a Premarket Notification (510k) and some clinical investigation, but not overly burdensome ones. Class III devices do require Premarket Approval (PMA) and clinical trials and/or evidence, except for already marketed devices. (5) This fits into the rules of medical device compliance set by the FDA and shows the differences from the MDR medical device regulation.

3. Approval Process

In the EU, the approval process is decentralised. (5) Once approved, devices are identified with the Conformité Européenne (CE) mark. To get this familiar mark, manufacturers must be audited by a Notified Body (NB), which is a preapproved organisation that can audit the technical evidence and manufacturing site for compliance to regulatory requirements. (6) If the device complies with EU medical device regulation, approval is granted, the CE mark can be applied, and the device can be marketed throughout Europe, although specific country registrations may also be necessary. (3) Depending on the complexity of the medical device, this approval process can take several months to many years.

In the U.S., the approval process for medical devices is solely through the FDA. FDA approval focuses on ensuring the device is safe and effective for patients, users, and the environment, while the EU focuses more on compliance to the MDR medical device regulation. (3)

While both the U.S. and EU are criticised for long approval times, approval time depends on many factors, including device complexity and risk. In the EU, regulatory approval does not mean speed to market. Other sources of EU red tape can slow approvals down. (5) In both systems approval depends on compliance to either the MDR medical device regulation or U.S. FDA CFR.

Conclusion

Understanding these three key contrasts between the U.S. and EU medical device regulation will help in navigating the approval process. Foremost, make sure the device is classified correctly to determine if clinical testing is required. Make use of compliance resources, such as the ISO standards for medical devices, because devices aligned with these standards are better positioned to undergo the approval process smoothly.

To pave the way to successful market entry, manufacturers can utilise strategic audits to ensure alignment with the ISO standards for medical devices. Check back next month to learn more about how strategic audits can streamline entry into the U.S. medical device market.

References:

1. Medical Devices - Worldwide | Statista Market Forecast. Statista.
2. Medical device classification. webgate.ec.europa.eu.
3. “Classification Overview: FDA Small Business Regulatory Education for Industry (REdI),” William M. Sutton Sept. 29, 2015.
4. “CE Mark Versus FDA Approval: Which System Has it Right?” CRSTEurope.
5. “Drugs and Devices: Comparison of European and U.S. Approval Processes,” Gail A. Van Norman, Drugs and Devices. JACC: Basic to Translational Science. 2016;1(5):399-412.
6. Notified Bodies. health.ec.europa.eu.