Already have FDA marketing authorisation and now setting your sights on Europe?
Join our webinar to learn how to transform your U.S. regulatory work into a compliant EU MDR submission, speeding up your time to market and reducing the cost of Notified Body reviews.
From USA to Europe: Accelerating Your Path to the Medical Device Market
📅 Date: Tuesday, 9th December 2025
🕒 Time: 4:00 pm UTC / 11:00 am ET / 8:00 am PT
🔗 Register: Our MS Teams event page
Our team has helped dozens of U.S. manufacturers successfully transition to the European market. We are proud of our 100% acceptance rate from Notified Bodies across all our submissions. Join us as we share:
- The key differences between FDA 510(k) and MDR equivalence requirements
- How to adapt your existing clinical evidence and integrate PMCF requirements
- Strategies for leveraging prior documentation to fast-track EU MDR approval
Your Roadmap to European Market Success
For medical device manufacturers based in the US, gaining FDA marketing authorisation is a major milestone. Generally, medical device manufacturers rarely limit themselves to a single market, with global expansion a key part of a long-term growth strategy. However, many assume that European regulatory expectations require an entirely separate development effort, but in reality, there’s substantial overlap in evidence, documentation, and technical strategy.
With a clear roadmap, you can avoid redundant testing, streamline your submission, and minimise costly Notified Body review cycles.
- Identify EU MDR classification
- Perform a Gap analysis
- Engage a notified body
- Conformity assessment
- Conduct clinical evaluation and risk management
- Align with EU-MDR Technical Documentation
- Develop PMS
- Submit for notified body review and obtain a CE mark
- Register in EUDAMED and maintain compliance
Understanding the Key Differences between FDA and EU MDR
Although ensuring device safety and performance is the ultimate goal of both the FDA and EU MDR frameworks, there are significant differences in the evidence expectations, documentation structure, and post-market obligations, which differ substantially. The MDR places greater emphasis on clinical evidence, risk management integration, and ongoing post-market performance evaluation, making it essential for FDA-approved companies to carefully adapt their U.S. regulatory data and systems for Europe.
Key areas of overlap
A major advantage of having FDA clearance or approval is that much of your existing documentation can be repurposed for EU MDR compliance. However, some new MDR-specific documents will be required to address the European regulatory focus on clinical evaluation, safety, and post-market performance.
Documents that can be repurposed
- Device description and specification
- Instructions for Use (IFU)
- Preclinical testing – Biocompatibility, EMC, Invitro + animal testing, Physical, Chemical, Microbiological tests, Software V&V, Stability & Shelf-life test
- Labelling & Packaging
- Substantial equivalence (if equivalence route)
New MDR documents required
- Clinical Evaluation Documents (CEP, CER & SOTA)
- Device manufacturing and information
- General Safety and Performance Requirements (GSPRs)
- Standards and common specifications
- Declaration of Conformity (DoC)
- PMCF, PMS, PSUR
- Risk Management per ISO 14971 – Characteristics related to safety, Criteria for risk acceptability, Evaluation of overall residual risk, Risk control, RMP, RMR, PHA
By strategically repurposing and aligning your existing data, you can reduce redundancy, streamline your submission, and cut both time and costs during Notified Body review.
Our webinar: Accelerating Your European Market Entry
Transitioning from FDA to MDR compliance doesn’t have to be difficult. With expert guidance and a structured approach, U.S. manufacturers can efficiently adapt their data, close any clinical or technical gaps, and achieve successful Notified Body approval.
Places are still available, so register to join our webinar here
