A medical device company planning to enter both the European and US markets does not necessarily need to treat the two regulatory pathways as completely separate projects.
The submissions themselves are different, and the regulatory logic behind them is different. But much of the underlying product development, testing and evidence generation may support both markets.
This creates an important opportunity.
If a company has already achieved CE marking, the technical documentation and evidence developed for the MDR can provide a valuable starting point for US market entry. But companies still preparing for CE marking may be in an even better position. By considering FDA expectations while testing, clinical evidence and technical documentation are still being planned, it may be possible to make decisions that support both regulatory pathways from the beginning.
The goal is not necessarily to pursue CE marking and FDA clearance at exactly the same time. It is to understand both destinations early enough that development work does not unintentionally create unnecessary duplication later.
Two regulatory pathways, one product development programme
It is easy to think of market access sequentially.
First complete the European project. Build the technical documentation, generate the necessary evidence and obtain CE marking. Then begin looking at the United States and determine what FDA requires.
There is nothing inherently wrong with this approach, particularly if the US market is only a distant possibility. But when both markets are part of the company’s realistic commercial plans, waiting until the European pathway is complete can mean discovering important FDA considerations relatively late.
The better starting question is often not which submission are we preparing first?
It is what evidence will this device ultimately need for the markets we intend to enter?
That does not mean every test or document can be shared between the two systems. It means that regulatory strategy can help shape development before important decisions have already been made.
Start by understanding the FDA pathway
One of the first things to establish is how the device fits into the FDA regulatory framework.
EU MDR classification should not simply be translated into a corresponding US class. FDA classifies device types according to its own regulatory system, and the applicable classification regulation, product code and device class help determine the regulatory controls and premarket pathway that may apply. FDA’s Product Classification Database links generic device types with product codes, classification information and applicable regulations.
For many Class II devices, the expected pathway may be a Premarket Notification, commonly known as a 510(k). Other devices may be exempt from premarket notification, require De Novo classification, or be subject to a PMA or another pathway.
Understanding this early matters because the US pathway can influence the evidence strategy.
A company that waits until most development and verification work has already been completed may discover that FDA expects a different comparison, additional testing, or a different way of presenting the evidence.
The regulatory pathway should therefore be considered part of product development planning, not simply something addressed once the product is finished.
If 510(k) is the route, predicate strategy matters
For devices entering the 510(k) pathway, one of the most important differences from the MDR approach is the concept of substantial equivalence.
A 510(k) submission demonstrates substantial equivalence to a legally marketed device, known as the predicate. FDA considers factors including intended use and technological characteristics when determining substantial equivalence, and differences must be adequately supported by appropriate evidence.
This makes predicate identification much more than an administrative exercise at the end of development.
FDA specifically notes that device classification and product code are important when searching for appropriate predicates, and devices within the same product code are often a logical starting point for the search.
Looking at potential predicates early can provide useful insight into how similar products have reached the US market and what characteristics will eventually need to be compared.
It can also highlight differences that may become important later.
If the planned device has different technology, materials, indications, software functionality or performance characteristics, those differences may affect the testing required to support the substantial equivalence argument.
In that sense, the predicate should support the development strategy rather than simply be selected afterwards to justify a finished device.
Plan the evidence with both markets in mind
This is where early EU and US planning can create significant practical value.
A manufacturer preparing for CE marking may already be planning extensive verification and validation work. Depending on the device, this could include bench performance testing, biocompatibility, electrical safety and EMC, software verification and validation, usability, sterilization validation, packaging validation and clinical evidence.
Many of these activities may also be relevant to FDA.
FDA’s 510(k) framework specifically recognises different forms of performance evidence, including engineering and bench testing, software validation, biocompatibility, sterility and clinical data where applicable. The extent of the evidence depends on the specific device and the substantial equivalence questions that need to be addressed.
This does not mean that a test performed for MDR purposes is automatically sufficient for FDA.
The important point is that the underlying evidence can often be planned with both regulatory pathways in view.
If the applicable FDA requirements, guidance documents, predicate characteristics and likely performance expectations are known before the test programme is finalised, the manufacturer can assess whether the planned work will adequately support both markets.
That can be much more efficient than completing a full verification programme and only afterwards discovering that an additional test, different comparison or additional data set is needed for the US submission.
Clinical evidence should also be considered early
Clinical evidence is another area where assumptions can create unnecessary work.
Companies sometimes approach 510(k) submissions with the assumption that clinical data will never be needed. Others assume that the clinical work being performed for MDR will automatically satisfy FDA.
Neither assumption is a good substitute for a device-specific evidence strategy.
FDA states that clinical data are not needed for most devices cleared through the 510(k) process. However, clinical data may become relevant where, for example, there are new or modified indications, significant technological differences, or nonclinical methods are insufficient to address the relevant safety and performance questions.
For a company already planning clinical activities for Europe, understanding this early can be particularly valuable.
If clinical data may eventually support both MDR and FDA objectives, the study design, endpoints, patient population and resulting data should be considered with those objectives in mind before the investigation begins.
Clinical investigations are expensive and time-consuming. Discovering afterwards that an important regulatory question was not addressed is one of the more difficult problems to correct.
What can actually be reused?
For a company that already has CE marking, the answer is often: quite a lot of the underlying work may still be useful.
Risk management, product specifications, design documentation, verification and validation reports, software documentation, biological evaluation, usability work, sterilization information and clinical evidence may all provide valuable inputs when preparing for FDA market entry.
But this is where an important distinction needs to be made.
Reusing evidence is not the same as reusing the regulatory argument.
An MDR technical file is built to demonstrate conformity with European requirements. A 510(k), where applicable, is structured around FDA requirements and the substantial equivalence determination. FDA expects the submission to identify information such as the device classification and predicate and to provide the relevant comparison and performance evidence supporting substantial equivalence.
The same test report may therefore be valuable in both pathways, but it may serve a different regulatory purpose.
That is why approaching US market entry simply as a conversion of the European technical file can be misleading.
The better approach is to identify what existing evidence can support the FDA strategy, determine what additional work is required, and build the submission around the requirements of the US pathway.
Earlier planning creates more options
The greatest opportunity exists when the documentation and evidence have not yet been finalised.
At that point, the manufacturer can still influence test plans, clinical strategy, specifications and development decisions.
Understanding both MDR and FDA expectations does not necessarily make the project more complicated. In many cases, it can make the overall development programme more coherent.
A test can be designed once with both markets considered. Clinical evidence can be generated with a clearer understanding of its potential regulatory uses. Differences between European and US requirements can be identified before they become expensive problems to correct.
And if the company ultimately decides to pursue one market before the other, that is perfectly reasonable. Parallel regulatory planning does not require parallel submissions.
It simply means knowing where the product is intended to go before completing the work that will eventually be used to get it there.
Building regulatory strategy around the markets you want to enter
For medical device companies with ambitions in both Europe and the United States, regulatory strategy should ideally begin before either submission is assembled.
The EU and FDA pathways remain distinct, and neither should be treated as a substitute for the other. But the product, development work and much of the underlying evidence are shared.
Understanding the FDA classification and likely pathway early, identifying potential predicates where a 510(k) is expected, and considering the evidence requirements of both markets can help companies make better development decisions.
For companies already CE marked, this means identifying how existing evidence can be leveraged effectively for US market entry.
For companies still preparing for CE marking, it creates an opportunity to design the development and evidence programme with both markets in mind from the beginning.
MDS supports medical device companies with both EU and FDA regulatory strategy, from early classification and pathway assessment through technical documentation, evidence planning and regulatory submissions. By looking at the intended markets together, we can help identify where work can support multiple regulatory objectives and where a market-specific approach is needed.
You can contact us at sales@mdsfinland.com or via Book a Meeting.
