Why your CE mark won't get you onto the US Market

For many European medical device companies, the US represents the next growth market. The surprise comes when they discover thata CE mark, established quality processes, and years of success in Europe do not automatically open the door to FDA approval or clearance.

A CE mark tells you your device is safe for the European market, but it carries no weight with the FDA. That single fact catches more EU medical device companies off guard than any other part of a US launch, and it's the reason a growing number of them are rethinking their go-to-market plan before they've written a single line of their FDA submission. It's also where we started a recent webinar on US market entry for medical devices, with Allyson M. Maur, partner at McGuireWoods, walking through exactly what EU companies get wrong here.

The EMA operates as a post-market surveillance body. One pathway applies to nearly every device, and oversight kicks in after the product is already circulating. The FDA works the opposite way. It is a pre-market gatekeeper: before your device reaches a single US customer, you need the right classification, the right pathway, and the evidence to back both up. Get that wrong early, and the delay shows up immediately.

The FDA runs on classification

The FDA sits under the Department of Health and Human Services and splits its regulatory work across three centers:

• CDER handles prescription drugs.
• CBER handles biologics.
• CDRH, the Center for Devices and Radiological Health, is where most medical devices land.

On top of these centers, the Office of Combination Products steps in whenever a device delivers a drug or biologic, and the Office of Regulatory Affairs runs the field inspections and enforcement once your product is on the market. Office of Combination Products will help determine whether your product will be primarily overseen by CBER, CDER or CDRH.

Each of these offices can apply to your device. A device that looks straightforward in the EU can trigger review from multiple FDA offices at once in the US, and each one applies its own requirements to your documentation, your evidence, and your timeline.

Four pathways, one classification decision

Once your device is classified, the FDA sorts it into one of three risk classes, and that class largely decides your pathway.

• Class 1 covers low-risk products such as bandages and basic first-aid items. Many of these qualify for an exempt pathway. Exempt Class I devices are still subject to general controls (registration, listing, labeling, GMP requirements), but they do not require specific approval.
  
  
• Class 2 covers moderate-risk devices like infusion pumps and powered wheelchairs, and this is where most products land. If a comparable device is already on the market, with a 510(k) submission you may be able to demonstrate substantial equivalence to that predicate device, which can be considerably faster than starting from scratch.
  
  
• Class 3 covers high-risk devices, historically implants, and this is where the Premarket Approval (PMA) pathway applies, with the most extensive clinical evidence requirements.
  
  
• A note about De Novo classification: De Novo classification is the pathway used where there is no predicate available as a Class I exempt or Class II under 501(k). A device arrives at De Novo precisely because it lacks a classification; it has no predicate and would otherwise default automatically into Class III. The FDA describes De Novo as a route for "novel devices of low to moderate risk." De Novo is a slightly longer process than 510(k).

One detail worth highlighting before you assume your product is exempt: misclassification is one of the most common and expensive mistakes companies make when entering the US market. A wrong assumption at this stage can impact timelines, create additional regulatory work, and in some cases force products off the market altogether

When your device becomes a combination product

Classification becomes especially important when the line between a device, a drug, and a biologic starts to blur.

A drug-coated device may be regulated as a medical device under the EU MDR. In the US, the same product may be considered a combination product, with the FDA determining its regulatory pathway based on its primary mode of action.

Take the now-familiar GLP-1 injector. The pen is a device, but the pen can deliver almost anything. What determines the regulatory path is the drug it delivers, which is why these products are regulated primarily as drugs, not devices. The same logic applies in less obvious cases. A dental varnish that occludes a cavity might be a device in the EU, but if it works through a chemical reaction inside the body rather than by physically sitting on a surface, the FDA is more likely to treat it as a drug. Antimicrobial or antiseptic claims carry the same risk: they read as drug claims to the FDA, regardless of how the product is classified elsewhere.

When the answer isn't obvious, EU companies can request a formal jurisdictional determination from the FDA before committing to a pathway. It surfaces a wrong assumption early, rather than after your 510(k) has already been reviewed.

Work with the FDA

Allyson M. Maur talked about it during our recent webinar on going to market in the US with medical devices: it's worth not assuming you're exempt, or assuming your risk class, simply because your product cleared the EU. Companies that skip the classification step are often caught off guard by how the FDA responds, and the fix afterward costs far more than the pre-submission meeting would have.

That collaborative step, a pre-IDE meeting with the FDA before you commit to a pathway, is one of the most cost-effective safeguards available to an EU company entering the US. It won't tell you everything, but it will tell you whether you're about to build a submission around the wrong assumption.

Classification decides your pathway. Your pathway decides your timeline. It also determines what level of traceability, documentation control, supplier oversight, and quality evidence you'll need to maintain once the product reaches the US market. Those requirements often expose operational gaps that weren't problematic in Europe but become highly visible during FDA review and inspection.

Your Next Step

Once your classification is settled, two questions follow.

• What happens when AI enters the picture, either inside the device itself or in the software managing it? Read more about that here: AI in Medical Devices: What the FDA's Predetermined Change Control Plan Actually Covers.
• And what your quality system needs to prove once you're on the market: Launching a Medical Device in the US? Start With These Four Steps.

Want the complete walkthrough of FDA classification and jurisdiction? Watch the full webinar here.