Marketing medical devices in France

Although the marketing of medical devices in France falls within the European regulatory framework, like elsewhere in Europe, pricing and reimbursement issues retain a strong national flavour.

Context and key actors

The French health insurance system

Medical expenses in France are mainly paid for by a mandatory national insurance system implemented by a small number of funds, coordinated through the Union Nationale des Caisses d'Assurance Maladie (UNCAM). This system is funded by a tax paid by employers and workers. Under harsh economic times and with an ageing population this system's budget is under tight pressure. This leads the French authorities to exert a firm control on the prices and reimbursement rates of health products and services. They also tend to be increasingly demanding about what they choose to reimburse.

Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS)

Although the AFSSAPS may be viewed as the French medicines agency, its role involves monitoring the safety of all health-related products, including medical devices. The AFSSAPS is notified of the arrival on the market of all class IIb or III devices and may decide to perform compliance checks. The AFSSAPS also appoints and controls notified bodies in France. Besides, it is responsible for the authorisation and follow-up of all interventional trials of drugs or devices.

Haute Autorité de Santé (HAS)

The HAS may be viewed as an equivalent of the British NICE or the German IQWiG. Aside from issuing clinical guidelines it is responsible for the assessment of the usefulness of drugs, medical devices and, more generally, health technologies.

Comité Economique des Produits de Santé (CEPS)

The CEPS is under the authority of the French ministries of health and economy. It is responsible for the negotiation of prices and reimbursement rates for drugs and medical devices. Its decisions rely heavily on the assessments performed by the HAS.

Comités des Médicaments et des Dispositifs Médicaux Stériles (COMEDIMS)

These local committees may be specific to a single hospital or responsible of a group of hospitals. Their role is to monitor proper in hospital use of drugs and devices and to maintain lists of recommended drugs and devices that form the basis for purchasing decisions within their hospital(s).

An overview of the process

As elsewhere in the European Union, the first step towards marketing a medical device in France is CE marking (see European regulatory framework). The next step is to apply for reimbursement. Three situations may then arise.

The device is used in hospitals and reimbursed as part of a Diagnosis-Related Group (DRG)

The decision to purchase the device will then be made on a per-hospital basis, upon advice from the COMEDIMS. The price will then be negotiated between the manufacturer and the hospital or, more likely, a group of hospitals.

The device is reimbursed in the framework of a medical procedure

If the procedure is not already in a list of reimbursed procedures it should be evaluated by the Commission d’Evaluation des Actes Professionnels (CEAP) which is part of the HAS. Such an evaluation may by triggered by a National Health Insurance fund, by a scientific society or by the HAS itself. A manufacturer willing to initiate such an evaluation should get in touch with the relevant scientific society. Based on the CEAP advice the price and reimbursement rate of medical procedures are set by the UNCAM after negotiation with professional unions.

The device is used in the community or is too expensive to be integrated to a DRG

The manufacturer should then request the addition of the device to the Liste des Produits et Prestations (LPP). The way to do this depends on the nature of the device.

If the device matches the indications and technical specification of a generic entry of the list it may marketed under this entry. The only requirement is to label the device accordingly and to notify the AFSSAPS.

If, on the other hand the device is innovative, it should be added to the list under its brand name. This will require its evaluation by the Commission Nationale d’Evaluation des Dispositifs Médicaux et des Technologies de santé (CNEDiMTS), also part of the HAS (see below).

Addition to the LPP is granted for a maximum time of five years but may be renewed. Renewal may entail a new evaluation by the CNEDiMTS.

Assessment for reimbursement by the CNEDiMTS

The aim of the evaluation is to assess the “Service Attendu” or Actual Benefit and the “Amélioration du Service Attendu” or Added Clinical Value (according to the CNEDiMTS own translation).

The Actual Benefit is assessed, for each claimed indication, by taking into account:

• The benefit/risk ratio of the device, as demonstrated by relevant clinical data,
• The place of the device in the management of the condition,
• The public health benefit for the French population.

The Actual Benefit may be considered sufficient or insufficient by the commission. In the latter case, reimbursement is likely to be denied.

The Added Clinical Value is rated on a five-point scale, from I, major, to V, absent. It may be viewed as a rating of innovation. It is nonetheless important to understand that an Added Clinical Value will not be granted on the sole basis of a technical description of the innovation but upon evidence that it translates into an actual clinical benefit.

Generic vs brand name pathway: pros and cons

Obviously, the generic entry pathway is much less demanding. For this reason, many manufacturers choose this solution even where their device does not precisely meet the generic description and, sometimes, even if it is truly innovative. This approach has several drawbacks.

Under a generic entry, your device will be bound to the price and reimbursement rate fixed for that entry. This will be markedly lower than the price an innovative device would get by a proper brand name registration. Thus, depending on your market size and on the expected price gain, investing in clinical investigation may be worth consideration before embarking on a less rewarding generic pathway.

From a commercial point-of-view, labelling your device with a generic description explicitly conveys the idea that it does not stand out from the bulk of other similar devices. Your claims of innovation are then less likely to be taken seriously by your customers.

Last, because many manufacturers rely on generic entries as an easy path, these categories tend to grow heterogeneous. Hence, these entries are periodically re-evaluated by the CNEDiMTS and may be revised or altogether removed, thereby forcing affected manufacturers to resubmit their device via the brand name pathway. This has recently drawn several unprepared manufacturers out of the French market.

Determination of price and reimbursement rate

The device price and reimbursement rate are negotiated between the CEPS and the manufacturer. The major factors influencing the CEPS decisions are the Added Clinical Value and the expected sales volume.

Further reading

The HAS Guidebook ( In a new window ) on medical device assessment in France