When international MedTech companies prepare their market entry in France, the same questions tend to arise repeatedly.
Do we need French clinical data?
Should we meet the Haute Autorité de Santé (HAS) before launching a clinical study?
Can we start selling before reimbursement is obtained?
At first glance, these questions may appear independent. However, they are often interconnected because they all influence reimbursement strategy, go-to-market execution, and future market adoption.
Therefore, understanding the French healthcare ecosystem early can help companies avoid costly delays and build a more effective market entry strategy.
Question #1: Are French Clinical Data Mandatory?
One of the most common misconceptions is that French authorities systematically require clinical studies conducted in France.
In reality, MedTech market entry in France does not necessarily require French clinical data.
Instead, the key question is whether the available evidence is relevant to French clinical practice and supports the expectations of the reimbursement pathway being pursued.
For instance, international randomized controlled trials may be perfectly acceptable if:
- the patient population is representative of French clinical practice
- the comparator reflects current standards of care
- the clinical endpoints are relevant for French decision-makers
- the evidence supports the claimed clinical benefit
Moreover, local evidence may sometimes strengthen a reimbursement strategy, particularly when organizational impact, healthcare resource utilization, or treatment pathways differ significantly from those observed in other countries.
As a result, the discussion should not focus on the nationality of the data but rather on its relevance for French healthcare stakeholders.
Source: HAS – Pathway of Medical Devices in France
https://www.has-sante.fr/upload/docs/application/pdf/2022-01/guide_pathway_of_medical_devices_in_france.pdf
Question #2: Should Companies Interact with HAS Before Starting a Study?
Many companies wait until their clinical program is completed before engaging with French authorities.
However, this approach may create unnecessary risks.
Indeed, early scientific interactions with HAS can help companies better understand:
- evidence expectations
- comparator selection
- target population definition
- relevant clinical endpoints
- future reimbursement considerations
Consequently, early dialogue may prevent the generation of evidence that later proves insufficient for reimbursement purposes.
In addition, the HAS guidance document entitled Rencontres précoces et conseils scientifiques provides useful information regarding these interactions.
Rather than viewing HAS solely as an evaluator, companies should also consider it a key stakeholder whose expectations deserve to be understood as early as possible.
Source: Early Meeting with HAS
https://www.has-sante.fr/upload/docs/application/pdf/2015-09/dm_modalites_de_soumission_et_deroulement_notice_23_dec._2013.pdf
Question #3: Can MedTech Companies Start Selling Before Reimbursement?
The short answer is yes.
CE marking allows commercialization in France before reimbursement is obtained.
Nevertheless, this does not automatically mean that hospitals will purchase the technology.
Instead, companies must demonstrate sufficient clinical and economic value to convince hospitals to allocate budget resources.
At this stage, go-to-market execution becomes critical.
For instance, successful early commercialization often relies on:
- engagement of key opinion leaders
- development of reference centers
- generation of real-world evidence
- physician training programs
- demonstration of organizational benefits
Therefore, reimbursement and go-to-market activities should never be viewed as strictly sequential.
In many successful projects, both processes evolve simultaneously and reinforce each other.
Strategic Perspective: Reimbursement and Market Entry Are Closely Linked
A recurring mistake among MedTech companies is to treat reimbursement and commercialization as two separate phases.
In reality, MedTech market entry in France is often an iterative process.
Clinical evidence influences reimbursement discussions.
Likewise, reimbursement expectations influence evidence generation.
Meanwhile, early adopters contribute to evidence generation.
Furthermore, early market adoption may strengthen future reimbursement discussions.
As a result, companies that integrate reimbursement and go-to-market planning from the outset generally create stronger market momentum.
Field Perspective: Reference Centers Often Become Strategic Assets
In practice, many successful MedTech launches in France begin with a limited number of highly committed centers.
These early adopters do much more than simply use the technology.
For example, they may:
- contribute to evidence generation
- validate clinical workflows
- support physician training
- present outcomes at scientific meetings
- influence broader adoption
Furthermore, these centers frequently become important references during reimbursement discussions.
For this reason, identifying future champions early is often just as important as defining the reimbursement pathway itself.
Executive Perspective: Market Entry Is a Sequencing Challenge
For a CEO or VP Europe, the challenge is rarely limited to obtaining reimbursement.
Instead, the real challenge lies in sequencing investments correctly.
Should resources be allocated first to clinical studies?
To KOL development?
To market access preparation?
Or to commercial infrastructure?
The answer depends on the technology, the reimbursement pathway, and the expected adoption dynamics.
Consequently, successful MedTech market entry in France often depends less on the amount of investment and more on the order in which those investments are made.
Strategic Implications
Companies frequently ask whether they need French data, early HAS interactions, or reimbursement before commercialization.
However, these questions should not be addressed independently.
Rather, they are components of a broader market entry strategy.
Ultimately, the objective is not only to obtain reimbursement.
More importantly, it is to build the conditions for sustainable market adoption.
Strategic Takeaway
Successful MedTech market entry in France is rarely determined by a single reimbursement decision.
Instead, it results from the alignment of clinical evidence, reimbursement strategy, go-to-market execution, and early adoption dynamics.
Ultimately, companies that understand these interactions early are generally better positioned to accelerate both reimbursement and commercial success.
