MDR vs. FDA 510(k): Where U.S. Playbooks Break in Europe (and How to Fix Them)

This is the first article in our MDR vs. FDA 510(k) series, focused on why U.S. regulatory playbooks fail under MDR and what companies can do differently.

Many U.S. MedTech and Life‑sciences companies assume that a smooth FDA 510(k) clearance will lead to an equally simple path toward CE marking under the EU’s MDR (Medical Device Regulation) or IVDR. In reality, the European pathway uses different rules, higher evidence expectations, and a more demanding review process. The result is often delays, added costs, and stalled commercial momentum. This article highlights the main gaps between FDA and MDR requirements and what companies can do to avoid common setbacks.

Key Differences at a Glance

Why FDA 510(k) success doesn’t automatically translate to MDR:

• MDR uses stricter classification rules, which can move devices into a higher risk class.
• Clinical evidence expectations are stronger, often requiring new data.
• Technical documentation must be more detailed, structured, and traceable.
• MDR requires active post‑market surveillance, not a reactive approach.
• Notified Bodies, not a centralized regulator, handle review and ongoing audits.

Where 510(k) Playbooks Break Under MDR

1. Classification Changes

A device considered moderate‑risk (Class II) by the FDA may fall into Class IIb or even Class III under MDR. This shift increases scrutiny and may trigger clinical investigations.

Example: A U.S. manufacturer passed FDA review with bench testing but learned that MDR classified their implantable device as Class IIb. This required a full clinical evaluation and delayed their EU launch by over a year.

2. Higher Clinical Evidence Requirements

The FDA emphasizes “substantial equivalence” and often does not require new clinical studies. MDR focuses on device‑specific clinical evidence demonstrating ongoing safety and performance.

Literature reviews alone are rarely sufficient. Many companies must generate new EU clinical data or PMCF (Post‑Market Clinical Follow‑Up).

3. More Complex Technical Documentation

An MDR Technical File is more demanding than a 510(k). Notified Bodies expect:

• A complete and traceable GSPR checklist
• A detailed risk-benefit analysis
• Clear mapping of indications, intended purpose, and claims
• A structured and well‑supported Clinical Evaluation Report (CER)

Even companies with ISO 13485 systems often need to significantly expand their documentation.

4. Proactive Post‑Market Surveillance

Under MDR, manufacturers must actively collect and analyse real‑world evidence. Requirements include:

• A Post‑Market Surveillance (PMS) plan
• PSURs (Periodic Safety Update Reports) for higher‑risk devices
• Ongoing trending and signal detection, not just incident response
  

5. Working with Notified Bodies

Unlike the FDA, Notified Bodies are private organizations with their own interpretations and expectations. The review includes detailed documentation assessments and annual audits.

Many U.S. teams are surprised by the level of interaction, back‑and‑forth questions, and variation in interpretation between different NBs. 

Real World Example

A U.S. surgical‑device company assumed their FDA 510(k) strategy would transfer directly to Europe. Their wound‑closure device was reclassified as Class IIb under MDR. Their submission lacked:

• A complete CER

• A Post‑Market Surveillance plan
• An MDR‑aligned risk‑management file
  

The Notified Body returned a long list of deficiencies, delaying the launch by 15 months. During that time, a competitor secured key distributor partnerships. 

Frequently Asked Questions

How is MDR different from FDA 510(k)?

MDR requires stronger clinical evidence, deeper documentation, and continuous post‑market monitoring.

Why is my MDR classification higher than FDA’s?

EU rules classify risk differently and often place devices in a higher category.

Do I need new clinical data for MDR?

Often yes, especially for implants, software, or when your evidence base is limited.