Already have FDA marketing authorisation and now setting your sights on Europe?
In our recent webinar on the 10th December 2025, we explored:
- The key differences between FDA 510(k) and MDR requirements
- How U.S. manufacturers can strategically repurpose existing FDA documentation and streamline their European submissions
- Predicate vs Equivalant devices
- How to adapt existing clinical evidence and integrate PMCF requirements
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.
The FDA is a single centralised authority offering predictable procedures, clear timelines, and defined costs.
Meanwhile, the MDR is enforced by individual EU Member States, while Notified Bodies (NBs) conduct conformity assessments. Timelines and costs vary significantly between NBs, and average certification times exceed 18 months from contract signature.
Actionable insight: Well-prepared documentation can remove months from your regulatory journey.
Can you reuse your FDA Documentation?
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 Plan (CEP), Clinical Evaluation Report (CER) & State-of-the-Art (SOTA) review
- Device manufacturing and information
- General Safety and Performance Requirements (GSPR checklist)
- Standards and common specifications
- Declaration of Conformity (DoC)
- PMCF plans, PMS and PSUR
- Risk Management per ISO 14971 – Characteristics related to safety, Criteria for risk acceptability, Evaluation of overall residual risk, Risk control, RMP, RMR, PHA
Actionable insight: A targeted MDR gap analysis clarifies what can be reused from FDA submissions and what must be newly generated.
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.
Predicate vs Equivalent devices
FDA allows a device to be cleared by demonstrating “substantial equivalence” to a predicate device already on the market.
Predicate device under the FDA
FDA allows a device to be cleared by demonstrating “substantial equivalence” to a predicate device already on the market.
Equivalence under the MDR
Equivalence under EU MDR is not the same as the predicate device concept in an FDA 510(k).
Benefits of Claiming Equivalence:
- Leverages existing clinical evidence from an equivalent device
- Reduces the need for new clinical investigations
To Claim Equivalence Manufacturers must demonstrate similarity across:
- Technical characteristics
- Biological characteristics
- Clinical characteristics
Actionable insight: Gather measurable evidence for Technical, Biological and Clinical characteristics. Include biological characteristics early.
Clinical Evidence and PMCF
FDA requirements for premarket evidence
FDA requirements focus on premarket evidence; post-market obligations are defined but not as extensive as MDR.
Clinical Evaluation under the EU MDR
EU MDR places strong emphasis on ongoing clinical evaluation. Manufacturers must:
- Demonstrate clinical safety and performance using robust clinical evidence
- Maintain continuous evaluation through PMCF activities
- Integrate risk management and clinical evaluation into a single, living system.
Actionable insight: Build a cohesive clinical evidence strategy that aligns clinical evaluation, risk management, and PMS/PMCF to maintain compliance throughout the device lifecycle.
Your Roadmap to European Market Success
For medical device manufacturers based in the US, gaining FDA marketing authorisation is a major milestone.
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
Transitioning from FDA to MDR compliance doesn’t have to be difficult.
Get in touch now if you’d like to discuss how our expert guidance, and structured approach can help U.S. manufacturers efficiently adapt their data, close any clinical or technical gaps, and achieve successful Notified Body approval.
