Across the Atlantic, the Medical Device Regulation (MDR) has replaced the older Medical Device Directive (MDD) as of May 2021. The MDR significantly tightens the rules — especially around clinical data, post-market surveillance, and transparency.
Devices are also split into risk-based classes (I, IIa, IIb, III), but unlike the FDA, the EU uses Notified Bodies — independent organizations that assess conformity — to evaluate most devices, especially higher-risk ones.
The MDR puts a spotlight on clinical evaluation. You need to provide strong evidence that your device performs as intended, and you’ll need to continuously gather and assess real-world performance data.
Key Differences and Challenges
- U.S. 510(k) vs. EU Clinical Emphasis: The U.S. process can be faster for lower-risk devices due to the 510(k) route. In contrast, the EU demands more upfront clinical proof, even for moderate-risk devices.
- Labeling & UDI: The U.S. requires Unique Device Identification (UDI) for most devices. The EU does too — but their format, requirements, and databases (like EUDAMED) differ.
- Timeline: EU certification may take longer, especially with a current backlog in Notified Bodies adjusting to MDR.
Final Thoughts
Launching a medical device is no small feat — and navigating dual regulatory systems adds complexity. But with the right preparation and regional strategy, you can unlock both markets.
Whether you’re submitting a 510(k) or prepping for MDR review, remember: regulatory compliance isn’t just a box to check — it’s your passport to trust, safety, and success.