Can FDA-Approved Devices Be Sold in Europe Without MDR Compliance?
For U.S. medical device manufacturers, gaining FDA approval is a major milestone, signaling that a product meets the rigorous standards for safety and efficacy required by the U.S. market. However, if your company is looking to expand into the European Union (EU), you may wonder if FDA approval is sufficient to start selling medical devices in Europe. The short answer is: no.
The European Union operates under its own regulatory framework for medical devices, with the Medical Device Regulation (MDR) being the primary legislation governing the approval and sale of medical devices. While FDA approval is an important credential, it does not automatically grant you access to the European market. To legally sell medical devices in the EU, you must comply with MDR or the older Medical Devices Directive (MDD), depending on the timeline for your product’s introduction.
Understanding CE Marking
To sell a medical device in the European Union, the most critical requirement is the CE marking. This marking indicates that your product complies with EU safety, health, and environmental protection standards, which are set out in MDR for most medical devices.
Unlike FDA approval, which is specific to the U.S. market, the CE marking is recognized across all 27 EU member states and several additional European countries. It signifies that your product meets the essential requirements of MDR or MDD and has undergone a conformity assessment, which varies depending on the risk classification of the device.
Why FDA Approval Doesn’t Translate
The regulatory requirements of the U.S. FDA and the EU MDR differ in several key ways:
- Device Classification:
The FDA and the EU classify medical devices differently. Under FDA rules, devices are categorized into Class I, II, and III, with Class I being the lowest risk and Class III the highest. The EU’s MDR uses a similar system (Class I, IIa, IIb, III), but the criteria for classification are different. For example, some devices classified as Class I in the U.S. might be considered higher risk (Class IIa or IIb) in Europe, requiring more stringent oversight.
- Conformity Assessment Procedures:
In the U.S., FDA approval often focuses on pre-market review through the 510(k) process or the Premarket Approval (PMA) process for high-risk devices. In contrast, MDR requires a conformity assessment that often involves third-party evaluations by Notified Bodies. For medium and high-risk devices (Classes IIa, IIb, and III), manufacturers must work with a Notified Body to assess compliance with MDR requirements.
- Clinical Evidence Requirements:
MDR places a heavier emphasis on clinical evidence than the FDA in some areas. While the FDA allows certain devices to rely on predicate devices (similar products already on the market) through the 510(k) pathway, MDR may require fresh clinical data for higher-risk devices. U.S. companies with FDA clearance might need to conduct additional clinical trials or studies to meet MDR standards.
- Post-Market Surveillance and Reporting:
Both the FDA and MDR require post-market surveillance, but MDR’s requirements are more rigorous, particularly for high-risk devices. Under MDR, manufacturers must submit Periodic Safety Update Reports (PSURs) and implement post-market clinical follow-up (PMCF) plans to continuously monitor the safety and performance of their devices after they enter the market.
Steps to Take if You Have FDA Approval but Want to Sell in Europe
If your device is already FDA-approved, here are some steps to help you navigate the process of gaining MDR compliance:
- Perform a Gap Analysis:
Review your FDA submission and compare it to the requirements of MDR. Identify areas where additional documentation, clinical data, or testing might be required. This analysis will help you understand what needs to be done to achieve CE marking.
- Engage a Notified Body Early:
If your device falls into a higher risk category (Class IIa, IIb, or III), you will need to work with a Notified Body to perform a conformity assessment. Notified Bodies are independent organizations authorized by EU governments to assess whether a product complies with MDR.
- Prepare for More Clinical Evidence:
MDR is more demanding when it comes to clinical investigations, especially for high-risk devices. You may need to conduct additional clinical trials or gather more clinical evidence than what was required by the FDA.
- Develop Post-Market Surveillance Systems:
Set up a robust post-market surveillance system to track the safety and performance of your device once it is on the market. This includes establishing systems for tracking adverse events and complying with MDR’s reporting requirements.
Conclusion
While FDA approval is a significant achievement, it is not sufficient for selling medical devices in the European Union. To enter the EU market, your device must comply with MDR, which involves obtaining CE marking, undergoing conformity assessments, and meeting the EU’s specific safety and clinical requirements. For U.S. companies looking to expand globally, understanding and navigating MDR is a critical step toward success in Europe.
