FDA vs MDR: 5 differences that matter to DM manufacturers

News

12 July 2025

1. Same product, two regulatory worlds

The same medical device. Two regulatory files. And yet, it sometimes seems as if they don't speak the same language.

European medical device regulations (MDR 2017/745) and FDA requirements in the USA share a common goal: to ensure the safety and performance of devices brought to market. But they do so with different philosophies, different procedures... and very real impacts for manufacturers.

In this article, we take a look at the 5 major differences between FDA and MDR, with concrete implications for your projects.

Spoiler: no, CE marking does not automatically open the door to FDA. And vice versa.

2. Difference #1 - Philosophy: presumption of conformity vs. demonstration of safety

On the MDR side: the European approach is based on a prescriptive logic. The manufacturer demonstrates the conformity of his device by applying detailed requirements (Annex I) and, if possible, using harmonized standards. These standards serve as a shortcut: by applying them, you benefit from a presumption of conformity.

On the FDA side, the approach is more pragmatic, and sometimes less clear-cut. There is no presumption of conformity via official standards. It's up to the manufacturer to actively demonstrate that his device is safe and effective, through the data he provides.

Practical consequence:

A well-structured CE technical file won't be enough for the FDA if the demonstrative logic doesn't add up. And conversely, a succinct 510(k) will never satisfy a notified body.

3. Difference #2 - Risk classes: 3 non-overlapping classes

In both systems, devices are classified according to risk. But the terminology is deceptively similar.

System	Risk classes	Example
MDR	I, IIa, IIb, III	IIa: short-term implantable device
FDA	I, II, III	II: moderate-risk device, 510(k) compliant

Please note: a Class IIa device in Europe may require PMA (Premarket Approval) if it is deemed high-risk by the FDA.

The notion of "class II" therefore has no direct equivalence between the two systems.

4. Difference #3 - Marketing procedures

🇪🇺 In Europe

CE procedure via a notified body (from class IIa upwards)
Drafting of a complete technical file (Annexes II and III)
Declaration of conformity, followed by CE marking
Timeframe: 6 to 18 months, depending on complexity and organization

🇺🇸 In the United States

Direct submission to the FDA
Depending on the case: 510(k), De Novo, PMA
Use of eSTAR format (mandatory since 2023)
Pre-submission strongly recommended to secure strategy
Variable lead times: 3 to 9 months for 510(k), up to 1 year for PMA

Remember: the FDA is both judge and jury. It examines, authorizes and monitors. No intermediaries.

5. Difference #4 - The role of clinical studies

🇪🇺 MDR

Obligation to justify clinical safety (Article 61)
Post-Market Clinical Follow-Up (PMCF)
Comparative studies or literature reviews as appropriate

🇺🇸 FDA

Least Burdensome" approach sometimes avoids clinical studies
But a PMA requires robust clinical data
Requirements are sometimes more flexible... sometimes much more stringent

Frequent pitfall: believing that CE clinical data is enough for the FDA. This is only true if they are well structured and if the protocol is aligned with American requirements (statistics, endpoints, population, etc.).

6. Difference #5 - The post-market surveillance system

Both systems require post-market surveillance. But here again, the logic diverges.

EU requirements (MDR)	FDA requirements
PMS Plan (Post-Market Surveillance)	Medical Device Reporting (MDR)
PSUR (Periodic Safety Update Report)	Recall reporting
PMCF plan (if applicable)	Regular FDA inspections
Centralized vigilance system (Eudamed)	FDA registry, MAUDE database

In practice: the FDA is more reactive, with highly regulated recall obligations. The MDR relies on a more preventive and documentary approach.

7. Case studies

Case #1 - A European start-up wants to sell in the USA

The company obtained its CE mark in 2024 for a class IIa diagnostic device.

It is aiming for the US market in 2025.

Classic mistake: believing that its CE file will suffice.
In reality: it will have to prepare a 510(k) in eSTAR format, with a well-constructed equivalence strategy.
Pre-submission is almost indispensable.
Budget: 10 to 20 k€ in submission costs alone.

Case #2 - An American manufacturer wants to enter Europe

He has a 510(k) since 2019 for an orthopedic implant.

But he underestimates the complexity of the MDR.

Surprise: his FDA dossier does not cover the requirements ofAnnex I, nor the proof of risk management according to ISO 14971.
The result: several months of work to "translate" his dossier into a CE format.
He also found out about the requirement for a European representative and Eudamed registration..

8. Mini FAQ

1. Does CE marking facilitate access to the FDA?

No. They are two independent systems. CE marking may be reassuring, but has no regulatory value in the USA.

2. What is a 510(k)?

An FDA notification procedure, based on equivalence with an existing device.

3. Can a single dossier be drawn up for CE and FDA?

No, but we can structure the "source" documents so that they can be reused and adapted to each format.

4. What are the biggest regulatory costs?

The FDA applies fees (from $7,000 to $100,000 depending on the type of submission). Audits by notified bodies can cost as much.

5. Do I have to repeat a clinical study for each region?

Not always, but the study must comply with local requirements: protocol, methodology, endpoints, ethics, etc.

9. Two worlds, one strategy

Access to Europe and the United States requires much more than translating a dossier.

It's a twofold regulatory strategy, which needs to be anticipated right from the development phase.

At CSDmed, we help you :

structure your data so that it can be reused on both sides of the Atlantic,
build dossiers adapted to the specific expectations of the CE and FDA,
avoid strategic errors and costly round-trips.

Are you targeting international markets? Let's talk about it.