Healthcare: Medical Devices 2023 Comparisons

In France, the rules applicable to healthcare products (medical devices, pharmaceuticals, blood products, personal protective equipment, medical instruments, etc) derive from EU law and national law (which is often a transposition of EU law).

The French Public Health Code (FPHC) sets out definitions and rules in relation to healthcare products. More precisely, Part V of the FPCH relates to medical devices and medicinal products.

Regulatory Regime Applicable to Medicinal Products

Directive (CE) No 2001/83, which was transposed under French law (Articles L. 5121-1 et seq of the FPHC; Articles R. 5121-1 et seq of the FPHC) sets out the rules applicable to medicinal products.

Regulatory Regime Applicable to Medical Devices

There are specific regulations applicable to specific medical devices. There are also general rules, which apply to all of these products, as set out by Articles L. 5211-1 et seq of the FPHC.

Two EU Regulations on medical devices are worth noting:

• Regulation (EU) 2017/745 on medical devices; and
• Regulation (EU) 2017/746 on in vitro diagnostic medical devices.

Regulation (EU) 2017/745 on medical devices was recently amended and will be applicable on 26 May 2024, following the expiry of the transition period (Conformité des dispositifs médicaux au règlement (UE) 2017/745: prorogation de la période transitoire). For some devices, the EU Parliament has voted to extend the transition period until 2028, to ensure that patients can access safe and high-quality medical devices. The new rules set out in these amended regulations aim at extending the scope of the products falling under the definition of “medical device” and strengthening the requirements and criteria for the design and manufacture of medical devices.

For its part, Regulation (EU) 2017/746 on in vitro diagnostic medical devices was implemented by French Act No 2022-1086 dated 29 July 2022. The requirements regarding the safety and efficiency of in vitro diagnostic medical devices, the traceability of these devices, European co-ordination in the field of in vitro diagnostic medical devices, as well as the transparency of the system, have been enhanced (Rapport au Président de la République relatif à l'ordonnance No 2022-1086 du 29 juillet 2022 portant adaptation du droit français au règlement (UE) 2017/746 du Parlement européen et du Conseil du 5 avril 2017 relatif aux dispositifs médicaux de diagnostic in vitro).

Regulatory Regime Applicable to Cosmetics

Cosmetics were first regulated by Directive No 76/68/ECC, which was transposed into national law under Articles L. 5131-1 to L. 5131-11, Articles L. 5431-1 to L. 5431-7, Articles R. 5131-1 to R. 5131-14, Article R. 5431-1 and R. 5431-2 of the FPHC.

Regulation (EC) No 1223/2009 on cosmetic products has subsequently replaced this Directive.

A French Act that recently entered into force is also likely to have an important impact on cosmetics, since a lot of their components are now prohibited (French Act No 2020-105 dated 10 February 2020). Indeed, pursuant to this Act, and since 1 March 2020, 23 chemical substances which are considered toxic or carcinogenic, are forbidden in cosmetics products.

Due to French Act No 2022-1726 of 30 December 2022, cosmetic products will no longer be qualified as medical products from 1 January 2024 (Veille permanente, Sortie programmée des produits cosmétiques et des produits de tatouage de la liste des produits de santé).

Regulatory Regime Applicable to Biocides

Biocides are chemical or organic products aimed at destroying, pushing back or annihilating harmful organisms. As such, biocides may have a negative impact on humans and on the environment.

All biocidal products require prior authorisation before being placed on the market, and their active substances should also be approved (Regulation (EU) No 528/2012). There are 22 biocidal product types, which are grouped in four main areas (disinfectants, preservatives, pest control, and other biocidal products).

At the national level, biocides are usually governed by the legislation applicable to chemicals of the French Environmental Code, to the extent they impact the environment.

However, biocides may also be subject to medical regulations. That is the case of medical disinfectants, which may fall under the scope of Regulation (EU) No 528/2012, which came into force on 1 September 2013. However, it should be noted that, as a principle, medical disinfectants cannot be characterised as medical devices per se. They may fall into this category to the extent a medical device needs to be disinfected before use (such as contact lenses or endoscope disinfectants).

Regulatory Regime Applicable to Food and Nutrition Supplements

French Decree No 2006-352 of 20 March 2006 has transposed Directive No 2002/46/CE, relating to food supplements, into French law.

The Regulatory Regime Applicable to Pharmaceuticals

Prior to being marketed on the European market, pharmaceuticals require a marketing authorisation (EU Regulation No 2017/745).

Pharmaceuticals are then subject to pharmacovigilance which involves detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem (Articles L5121-22 et seq the FPHC.)

It should also be noted that there are strict regulations governing the promotion and advertising of pharmaceuticals under French law (Articles L5122-1 et seq of the FPHC). The aim of such regulation is to ensure that manufacturers, healthcare professionals, and the general public all communicate in a clear, evidence-based manner.

The Regulatory Regime Applicable to Blood Products

In France, blood products are strictly regulated by the FPHC (Articles L. 1221-1 et seq and Articles L. 1271-1 et seq of the FPHC). This strict regulation is the consequence of the infected blood scandal which occurred in France in the 1990s following distribution of blood products contaminated with HIV and hepatitis C by a medical centre.

Specific rules are set out in relation to the donor, transportation, the safety chain and the storage of the product.

Also, the French Blood Establishment (EFS), created in January 2000, has the monopoly, in France, on the collection, testing, preparation, and distribution of labile blood products (Articles L. 1222-1 to L. 1222-16 of the FPHC).

The Regulatory Regime Applicable to Psychedelics

The Vienna Convention of 21 February 1971 sets out the rules on psychedelics substances, which member states (including France) are bound to follow.

Since the enactment of French Act No 2020-1525 on 7 December 2020, the classification of poisonous plants, substances, or preparations as narcotics is set via a decision of the Director of the French National Agency for Medicines and Health Products Safety (ANSM) (Article L. 5132-7 of the FPHC). The list of classified narcotic substances, consisting of four annexes, was initially established by a French Decree on 22 February 1990, and has been amended over time.

In principle, narcotics are prohibited – the production, marketing, use, and, in general, all agricultural, artisanal, or commercial operations involving substances or preparations classified as narcotics are prohibited, except in the event express authorisation is granted (Article R. 5132-74 of the FPHC).

The Regulatory Regime Applicable to Cannabidiol (CBD)

In France, there is a general prohibition of any operation (including the production, transport, possession, sale or use) involving cannabis and its derivatives (as provided by Article R. 51232-86 of the FPHC).

By way of exception, the farming, import, export and industrial and commercial use of the seeds and fibres of a variety of Cannabis, the Cannabis sativa L. variety, is allowed providing the following conditions are met:

• the concerned variety is one of the authorised varieties;
• only the seeds and the fibres are to be used; and
• the THC content of the plant variety does not exceed 0.20% (these conditions are set out by a Decree dated 22 August 1990).

However, in a recent case, this strict regime was challenged before the CJEU. Indeed, in a landmark decision, the court held that CBD is not a narcotic drug and that member states are not allowed to prohibit its marketing (CJEU, 19 November 2020, Case C-66318). In other words, French laws banning hemp-derived CBD were found contrary to EU laws.

The French government refused to apply this European decision and introduced an order dated 30 December 2021, prohibiting the sale of cannabis flower and leaf. However, for the authorised varieties only, this order also increased the allowed rate of THC to 0.30%.

This order was partially cancelled as from 29 December 2022, following a decision of the higher court of the administrative system in France; ie, the Conseil d’Etat (CE, 29 décembre 2022, No 444887). The allowed rate of THC is, to this day, still up to 0.30%.

The French regulation of CBD is still blurred and is likely to evolve in the next few years.

The Regulatory Regime Applicable to Clinical Trials of Medicinal Products

Initially, Directive 2001/20/EC of 4 April 2001 on the approximation of the laws, regulations and administrative provisions relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use was applicable to clinical trials.

Clinical trials are now regulated by EU Regulation No 536/2014 (Clinical Trials Regulation, CTR) which came into force on 31 January 2022.

However, if the application for clinical trial authorisation is submitted between 31 January 2022, and 31 January 2023, the clinical trial could be initiated in accordance with the 2001 directive (Dictionnaire permanent, Médicaments: essais cliniques, 2023, §2 et §3).

Regarding domestic legislation, Article L. 1124-1 of the FPHC is the primary source of law for clinical trials.

Regulatory Regime Applicable to Medical Apps

Healthtech businesses have spread rapidly in France, particularly over the last decade. As a result, medical apps have developed and now cover a wide range of activities and specialisations in the health sector.

However, and considering that medical apps are rather recent, there is no specific regulation applicable to these apps.

However, it should be noted that:

• like every other piece of software collecting data, they must comply with the General Data Protection Regulation (EU) No 2016/679 (GDPR); and
• a medical app may be characterised as a medical device, since the French definition of medical devices includes “software designed to be used specifically for diagnosis or treatment purposes” (Article L. 5211-1 of the FPHC).

To the extent that they do qualify as medical devices, medical apps may be obliged to comply with the applicable regulation, which notably derives from Regulation (EU) No 2007/745. It should be noted that a Medical App may qualify as a medical device if it meets the following cumulative conditions:

• it is intended for medical purposes;
• at least one of its functions enables it to use patient-specific data; and
• this date is processed in order to provide new medical information (Court of Justice of the European Union (CJEU), 7 December 2017, Case C-329/16).

On 11 May 2023, the French Data Protection Authority (CNIL) imposed a fine of EUR380,000 on the main French medical app, called Doctissimo, for failing to comply with obligations under the GDPR, including the requirement to obtain individuals’ consent for the collection and use of their health data, as well as for not adhering to rules regarding cookies (Veille permanente, Doctissimo sanctionné par la CNIL pour ses manquements au RGPD).

Regulatory Regime Applicable to Telemedicine

Telemedicine is a form of remote medical practice that was introduced into the FPHC under Articles L. 6316-1 and R. 6316-1 et seq of the FPHC.

It was amended by a 2010 Decree (Decree No 2010-1229), implementing a national Act dated 21 July 2009, which reformed the hospital system. The decree defines the medical act that may be realised through telemedicine and the different conditions of application of telemedicine (which are teleconsultation, telexpertise, telesurveillance, tele-assistance and medical regulation).

Telexpertise allows health professionals to request the advice of professionals of other specialities, through digital means. Telesurveillance allows the practitioners to interpret health data without examining the patient.

In 2018, the French National Health Insurance Fund allowed the reimbursement of telemedicine (Articles L. 6316-1 et seq of the FPHC).

In the context of the COVID-19 pandemic, and following the public health emergency Act dated 23 March 2020 (which was extended until June 2021), the rules applicable to telemedicine were modified in an attempt to expand the practice and offer greater protection to patients. All teleconsultations were fully reimbursed by public insurance.

Regulatory Regime Applicable to Wearables

Wearables have also spread over the last few years. These objects collect health data on a daily basis, and to that extent, should strictly comply with data protection legislation, including the GDPR. Depending on the device, medical device regulations may also apply.

Regulatory Regime Applicable to Stem Cells

French Act No 2021-1017 of 2 August 2021, relating to bioethics, has furthered the evolution of legislation in favour of stem cell research. Unlike research on embryos, stem cell research is subject only to a prior declaration regime (Dalloz, loi de bioéthique: les grandes lignes d’une réforme attendue).

French Decree No 2022-294 of 1 March 2022, concerning research on stem cells, establishes the conditions for the implementation of this new regime.

The classification of products may sometimes be discussed, especially when said products are destined to be used in different sectors (environment, food industry, beauty industry, etc). As a result, the correct regime applicable to these products, which may be referred to as “borderline products”, is sometimes difficult to determine.

In order to facilitate the distinction between products, several instruments were put in place. Guidelines were issued by the European Commission and national governments, notably covering the distinctions between cosmetics and medicines.

Moreover, in borderline situations, and in the event a claim arises in this respect, French courts may decide which categories apply to which products on a case-by-case basis.

Finally, the ANSM may also rule on the classification of a product, taking into consideration its composition, its scientific properties, its mode of use, etc.

Manufacturing entities are subject to several requirements both prior to and after the marketing of health sector products, including medical devices, healthcare products and products featuring new technologies. These requirements depend on the product. However, the same steps are generally followed by the manufacturers of the health sector products, as summarised below.

Application (ie, Prior Authorisation or Declaration)

The manufacture of medical products is usually subject to prior authorisation granted by the ANSM.

Manufacturers of blood products are subject to prior authorisation by the ANSM. Indeed, establishments carrying out transfusions must be approved by a decision of the ASNM. Moreover, any activity involving the preparation, storage, distribution, transfer, import or export of tissue, as well as its derivatives, cells and cell therapy preparations from the human body, used for therapeutic purposes, is also subject to prior authorisation from the ANSM.

The preparation, conservation, distribution, or transfer of advanced therapy medicinal products prepared on an ad hoc basis (including experimental medicinal products) is subject to prior authorisation from the ANSM.

However, the manufacturers of both medical devices (Article L. 5211-3-1 of the FPHC) and cosmetics (Articles L. 5131-2 and T. 5131-1 of the FPHC) are only subject to a declaration (which is distinct from a pre-authorisation) to the ANSM.

It should also be noted that entities other than the ANSM may be involved in this pre-authorisation/declaration process. More precisely, the development of the healthtech sector has led to new requirements in relation to data protection. As a result, any person hosting personal health data in the context of prevention, diagnosis, care, social or medico-social healthcare must be certified as a health data hosting service provider pursuant to Article L. 1111-8 of the FPHC. The conditions of approval are set by decree, and subject to a consultation of the Data Protection Authority (CNIL).

Conditions of Approval

Manufacturing authorisations may be delivered only if the product, the manufacture site and the manufacturer meet the conditions presented under the good manufacturing practice (GMP) guidelines (which – at the EU level – is regulated by Directive No 2003/94/EC).

Other guidelines may apply depending on the manufacturer’s activity. For instance, the manufacture of medicinal products must be realised by a pharmacist or a company in which a pharmacist participated in the management or board of directors.

Examination of the Application

Both the declaration and the authorisation procedures must be done online up to 60 days before any activity starts. Manufacturing authorisations are granted within 90 days as from the receipt of the application.

Initial authorisations are not subject to any fees.

It should be noted that the application may sometimes be subject to an inspection of the facility by an expert – whose mission is, inter alia, to verify the facility’s ability to carry out its activities in compliance with the applicable requirements.

Period of Authorisation and Renewals

Authorisations are granted for an unlimited period of time.

However, suspensions or withdrawals may be decided by the ANSM following inspections revealing hypothesis of breaches of the applicable standards.

Inspections

Inspections aim at assessing the compliance of manufacturers with good practice and other applicable standards.

In this process, inspectors can analyse samples and can be authorised by a court to seize products.

An inspection report usually summarises the breaches/deviations from required standards. The inspection report is drawn up during a process in the presence of all the parties (ie, an adversarial process) which includes a preliminary report to the operator. As a result of this report, and if the site is deemed not compliant, appropriate decisions may be taken. Moreover, inspections can lead to administrative measures being taken by the ANSM, including injunctions, suspensions, the withdrawal of authorisation or the approval of financial penalties.

There are no specific obligations in respect of corporate social responsibility, environment and sustainability throughout the product life cycle. However, manufacturers are largely encouraged by the French government to take measures in this respect, if practicable. Moreover, manufacturers usually publish measures that they plan on implementing in order to improve their position on social responsibility, the environment and sustainability.

Applicable Rules on Advertising and Product Claims Under French Law

Under French law, the FPHC strictly regulates advertising and product claims in respect of healthcare products and medical devices. Moreover, the French Consumer Code, which is also applicable in the heath sector, prohibits unfair, misleading practices and comparative advertising (Articles L. 121-1 et seq, Articles L.122-1 et seq).

There is also soft law on this subject:

• the ANSM provides for general recommendations and guidelines on the matter; and
• on 25 March 2022, a new version of the MedTech Ethics Code entered into force. The revisions have been effective since 1 January 2023.

This code aims at regulating all aspects of the industry’s relationship with healthcare professionals and healthcare organisations, at ensuring that all interactions are ethical and professional at all times and at maintaining the trust of regulators, and – most importantly – patients. As such, the code contains rules on advertising which are applicable to all the member parties (the MedTech Europe corporate members became signatories of this Code on 1 January 2017).

Finally, it is worth noting that a French ministerial order laying down a Charter on the quality of professional practices for the presentation, information or promotion of medical devices for individual use, other health products and any associated services was published on 8 March 2022. This Charter sets out a new framework for providing information and carrying out promotional practices in relation to reimbursed medical devices. It applies to products and services reimbursed by the French social security system and is used, notably, in pharmacies and health institutions. Non-compliance with the Charter by a company can lead to a financial penalty.

Presentation of the Requirements in Respect of Advertising and Product Claims Under French Law

Medical advertising requires a prior authorisation (an “advertising visa”) or a certification. Products must comply with the marketing authorisation or certification and the therapeutic strategies recommended by the French National Authority for Health (HAS). The advertisement of the product must be objective and not misleading or endanger public health and/or consumer safety.

The advertising requirements for products vary depending on the audience (general public or healthcare professionals), the payers and the reimbursement systems for those products.

Pursuant to the Toubon Act No 94-665 dated 4 August 1994, the use of French language is compulsory. The aim is to protect French consumers, as well as to preserve the French language, and promote French culture. A failure to comply with this Act may lead to a fine of EUR3,750 per non-compliant product.

The FPHC has provisions for penalties for advertising violations that can go up to a EUR750,000 fine and two years in prison for the company’s legal representative. For the companies involved, fines can be five times as high.

French Act 2023-451 of 9 June 2023, applicable from 17 February 2024, subjects online influencers to the same rules governing advertising.

Examples of Specific Requirements

The advertisement of biocides, which may be particularly dangerous for the environment, is strictly regulated (Articles L. 522-18 to L. 522-19 and Articles R. 522-16 to R. 522-17 of the French Environment Code). Decree 2019-642 of 26 June 2019 specifies the types of biocides which may be commercialised and the form of advertisement that a biocide product may take.

The advertisement of food and cosmetics is not subject to prior authorisation by the ANSM. However, some rules must be respected by the advertiser. For instance, the advertisement cannot mislead consumers. Moreover, the presentation of the product must not refer to the product as being able to cure or prevent diseases (in this event, it could be considered as a medicine by the regulators).

Under French law, several requirements must be met for a product to be validly placed on the market.

Indeed, in order to be placed on the French market, medicinal products must receive prior authorisation (AMM) issued either by the Director General of the ANSM or by the European Commission after evaluation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Evaluation Agency (EMA).

For medicinal products intended to be sold in European countries, specific procedures should be followed. The access to the market should be made either through:

• the centralised procedure (defined in Regulation No 2309/93/ EEC amended by Regulation No 726/2004/EEC);
• the mutual recognition procedure (provided for in Directive 2001/83/EC amended by Directive 2004/27/EC); or
• the decentralised procedure (provided for in Directive 2004/27/EC).

To obtain an AMM, the manufacturer of a medicinal product must submit a file containing all the scientific results obtained during the development of the product, as well as the clinical studies. The file must contain proof of the quality, safety, and efficacy of the drug, with a favourable benefit/risk ratio.

In France, national marketing authorisations granted by the ANSM are valid for a period of five years, renewable without time limits.

It should also be noted that after obtaining the authorisation and after putting their product on the market, the manufacturers of a medicinal product must appoint an internal representative for pharmacovigilance, whose contact details must be shared with the ANSM. A periodic report must also be given to the ANSM detailing any adverse reactions to the product, and any prohibition or restriction regarding the product that could have been imposed by the competent authority. Finally, if any incident happens, if any serious risk occurs of if a recall happens, manufacturers should also notify the ANSM.

Other products should also obtain authorisation in order to be placed on the market:

• pursuant to Regulation (EU) No 528/2012, biocide goods should also be granted a marketing authorisation;
• the French Agency for Food, Environmental and Occupational Health and Safety (ANSES) is the competent institution that delivers marketing authorisation for food products; and
• the manufacturer of cosmetic products is required to prepare a file to the ANSM that includes a human health evaluation, taking into consideration the toxicological profile of the components used in its formula and the level of consumer exposure.

Internationalisation plans may be put in place by French manufacturers of health products. Indeed, manufacturers may decide to export and sell their products to other countries.

However, the circulation of health products is not unlimited and is subject to strict conditions. For instance, in a decision related to the circulation of a medical product, the CJEU held that a medicinal product, which is not subject to prescription in one member state, may not be placed on the market in another member state, unless that member state has granted its marketing authorisation (Case C-178/20, 8 July 2021). Therefore, the European principle of freedom of movement does not seem to be applicable to health products.

At the international (non-European level), health products should also meet the conditions of the foreign country to which they are exported, in order to be marketed in such country. 

This may be explained by the fact that countries have different health policies and regulations.

The French regulatory authorities of the healthcare sector are invested with a general mission of surveillance and, as such, should ensure that the products placed on the market present, on balance, more benefits than risks. In this context, healthcare agencies should also verify the quality and the safety of the products.

For instance, the ANSM has established several surveillance systems such as:

• pharmacovigilance (for medications);
• reactovigilance (for in vitro medical devices);
• cosmetovigilance (for cosmetics);
• nutrivigilance (for food supplements); and
• materiovigilance (for medical devices).

If needed, corrective actions can be taken to reinforce the products’ safety which can also lead to their being recalled from the market.

Moreover, French regulatory authorities usually conduct inspections to ensure that the rules are being properly followed and regulations properly applied. Inspections may result in administrative actions forcing the manufacturers to comply and can vary from an injunction to financial fines. These sanctions can even lead to the suspension of activity.

In France, there are several regulatory authorities intervening in the health sector. The mission of these health agencies is to regulate the health sector; ie, to set and define rules applicable to medical devices, healthcare products and any other related products.

The role and mission of each of these agencies are governed by the French Act No 2016-41 dated 26 January 2016.

In France, the main health agencies are:

• the ANSM, which is a public institution with a general mission of control and regulation of healthcare products;
• the French National Authority for Health (HAS), which is an independent public body created to bring together a number of activities designed to improve the healthcare system, and to guarantee equity and patient-care quality;
• at the local level, the French Regional Health Authorities (ARS) control public health policies and regulate the supply of healthcare in each of the relevant regions; and
• the French Directorate General of Healthcare Provision (DGOS) evaluates the healthcare supply policy, in line with the priorities and objectives of national health policy.

There are also specific health agencies such as:

• the French National Digital Health Agency (ANS), which supports and reinforces the digital transformation of the healthcare system, by implementing digital tools for health purposes;
• the French Agency for Food, Environmental and Occupational Health & Safety (ANES), which is a public administration body reporting to the Ministries of Health, Environment, Agriculture, Labour and Consumer Affairs whose mission consists in providing the scientific benchmarks needed for protection from risks related to food, the environment and the workplace; and
• the CNIL, which is an independent public institution whose mission is to ensure the protection of personal data – which is often disclosed in the health sector.

In order to allow effective regulation of the healthcare sector, French regulatory agencies are granted several powers of investigation and control. They may also send reports to the ministry/authority they depend on, and request measures if and when necessary.

It should be noted that the ANSM has increased powers since French Act No 2011-2012 of 29 November 2011, since it is entitled, inter alia, to:

• investigate by carrying out inspections on sites;
• monitor the manufacture, distribution, advertisement, marketing and sale of the products, by conducting investigations – these investigations can also be held jointly by several regulatory authorities who can use complementary powers; and
• impose administrative injunctions, sanctions or suspensions of authorisations.

The other health agencies also have significant powers. For instance, the CNIL is entitled to alert the public in the case of a breach of the applicable rules but also to carry out investigations and impose sanctions if needed.

The FPHC sets out the criminal offences and monetary penalties that may be pronounced in the case of a breach of the applicable rules and regulations (fourth part and fourth book of the FPHC).

The sanctions may apply in case of breach of several rules, set out in the FPHC, such as a failure to comply with the rules applicable to medical devices, cosmetics or in vitro diagnostic devices.

The sanctions that may be imposed are of both a criminal and civil nature and are usually pronounced by the ANSM.

Criminal penalties depend on the nature of the breach. For instance, advertising of medical products and devices with early authorisation may lead to a sanction of one year’s imprisonment and a EUR150,000 fine. The distribution, production, brokage, advertising, sale, import or export of falsified medicine can be sanctioned by a EUR375,000 fine and five years in prison.

The FPHC also provides for monetary penalties in the case of infringements of certain rules (Articles L.5421-8, L.5422-18, L.5423-8, L.5461-9, L.5462-8, R.5461-4 and R.5462-4 of the FPHC).

These financial sanctions cannot exceed 10% of the gross turnover, up to EUR1 million, for a company, and EUR150,000 for a natural person. The daily fine for a delay in performance or compliance with an ASNM order cannot exceed EUR2,500 per day.

In 2021, the ASNM ordered six penalties for a total amount of EUR508,048. On 27 April 2022, the ANSM published a report announcing it might decide to apply penalties in cases of falsification of advice from a hospital’s ethics committee and research on human subjects without prior authorisation.

Under French law, claims based on the defect of a product should be exclusively grounded on the product liability regime (Article 1245 et seq of the French Civil Code – FCC). Indeed, the product liability regime, which derives from a transposition of Directive No 85/374/EEC, cannot be contractually waived if the cause of the damage allegedly suffered is the defect of the product. This regime applies even in the presence of a contract between the parties.

In the case of an alleged defect in a product, a party may also bring a claim on the basis of the warranty for latent defect regime (Articles 1641 et seq of the FCC). It should be noted that the time limitation applicable to this type of claim is shorter than the one applicable to product liability claims (two years as from the discovery of the defect for the warranty for latent defect regime and three years as from the discovery of the defect, the identity of the producer and the damage in the context of the product liability regime).

If the claim is not related to the defect of the product, it may be grounded on:

• contractual provisions – therefore, and in order to incur contractual liability, the claimant should prove (i) a breach of contractual provisions, (ii) damage, and (iii) a causal link between the alleged breach and the damage (it should be noted that only the foreseeable damages are compensable under French law); and
• torts – if the special regime of liability for goods is not applicable, a claimant may try and incur a party’s liability by proving (i) a fault, (ii) damage, and (iii) a causal link between the alleged fault and damage (Article 1240 of the FCC).

It is also worth noting that under the product liability regime, producers are exempted from liability when, at the time they put the product into circulation, the state of scientific and technical knowledge did not allow for the detection of the defect. This exemption for “development risk” is in favour of technological advancements (Faut-il repenser l'exonération pour risque de développement? – Marie Cartapanis – RTD civ. 2021. 523). To address the risks that this may entail, public authorities sometimes establish compensation funds in cases of serial damage (Faut-il repenser l'exonération pour risque de développement? – Marie Cartapanis – RTD civ. 2021. 523).

In France, rules on jurisdiction of the courts derive from European law, when and if applicable, and more precisely from the Regulation No 1215/2012 (Brussels I bis). These rules may also result from the provisions of the French Code of civil procedure (FCCP), which applies in national and international (non-European) matters.

A claimant should first determine the nature of their claim (civil or commercial) to identify the competent jurisdiction. In civil matters, the claimant should seize the court of the defendant’s domicile (Articles 42–48 of the FCCP). This principle applies to cross-border litigation (French Supreme Court, 1st Civ. 14 March 2006, No 05-13.820).

There is an exception to this rule applicable to consumers. Indeed, a consumer may seize the court of the place of its domicile under Article 18 of the Brussels I bis Regulation. Under Article R.631-3 of the French Consumer Code, a consumer may also decide to bring the case before the Court located where they were domiciled when the agreement was entered into or the court located where they resided when the damage arose.

The “loser pays” principle is not as strong in France as it can be in common law countries.

There are, however, some costs rules applicable to French claims (which are not limited to product liability claims). More precisely:

• pursuant to Article 696 of the FCCP, the winning party may recover all the procedural costs listed under Article 695, which include the service fees and the court-appointed expert’s fees; and
• pursuant to Article 700 of the FCCP, a party may claim and recover all the costs that are not procedural costs (including lawyers’ fees incurred in the context of the proceedings).

The parties are free to claim any amount under Article 700 of the FCCP but should justify their request. The court will then rule, on a case-by-case basis, whether this amount should be granted, in light of the representations made by the parties and also of the equity between the parties.

Most of the decisions of regulatory bodies can be challenged before administrative courts. This does not concern preparatory acts, advice or recommendations which are not binding (guidelines, etc).

Class actions are not allowed per se under French law. However, group actions may be issued before the courts.

The group action mechanism is quite recent in France since it was introduced by the Hamon Act of 17 March 2014. Under the provisions introduced by this Act, consumer associations are entitled to bring claims in respect of consumer law and competition law breaches, providing at least two of the consumers suffered the same damage. In order to validly bring proceedings, the consumer association should also have the capacity to issue such proceedings.

On 26 January 2016, the group action mechanism was extended to the healthcare products and cosmetic fields (Article L.1143-1 of the FPHC). It is on the basis of this new regime that the Depakine cases were brought before French Courts. In a recent decision dated 5 January 2022, the Paris Judicial Court held Sanofi liable for the damage caused as a result of the administration of Depakine to pregnant women, since it failed to observe its obligation of vigilance and information on the risks attached to this medicine. This is a landmark decision since it is the first decision relating to a group action in the health sector. Please refer to the France Trends & Developments chapter in this guide for further discussion of the Depakine case.

Even though there is no public listing of group actions, it should be noted that some actions are still pending and relate to consumer goods, health products, data protection, housing and discrimination.

EU Directive 2020/1828/EU for the protection of the collective interests of consumers dated 25 November 2020 required Member States to introduce a mechanism for group actions in consumer law.

The directive has been transposed into French law through an act dated 15 December 2022. The bill has been passed by one chamber of the French Parliament but is currently under review by the second chamber. The proposed law modifies the current regime and harmonises the framework for all collective redress actions.

In France, it is not mandatory to try to settle a case through an alternative dispute resolution (ADR) mechanism before issuing proceedings before the courts.

There are exceptions to this principle:

• for small claims (less than EUR5,000), under specific conditions stated by Article 750-1 of the FCCP (this provision was suppressed, but was reinstated on 13 May 2023); and
• in the event the parties agree, by contract, to try and settle their claim through a mediation or a conciliation procedure before any proceedings.

The parties are bound by their agreement and the court may reject a party’s claim in the absence of any attempt to settle the dispute prior to a trial.

Claims in relation to product safety compliance may be brought before civil, criminal or administrative courts.

Civil litigants may also report to any regulatory authority any violation of law or regulations.

Product safety and product liability in respect of environmental impact is governed by the French Act No 2020-105 of 10 February 2020, which was issued to prevent waste and to achieve zero single-use plastic by 2040, as well as to end the use of micro-plastic by 2040.

In order to avoid wasting medicine and medical products, the law states that pharmacies have been able to sell medicines individually from January 2022 (Article 40 of the French Act No 2020-105).

The EU regulations applicable to medical devices (EU Regulation No 2017/745) and in vitro devices (EU Regulation No 2017/746) were recently amended.

The aims of these amendments were, inter alia, to:

• redefine the responsibilities of economic operators;
• modify the system of classification for medical devices; and
• impose new requirements for marketing surveillance and require new transparency duties and obligations.

The EU regulations on Medical Devices were to apply from 26 May 2021. However, due to the pandemic, the European Parliament handed down a decision postponing the beginning of their application by a year, until 26 May 2022. The transitional period, during which member states will have to implement the provisions of the Regulation into their national law, will end on 26 May 2024.

No similar decision has been handed down by the European Parliament regarding the EU In Vitro Diagnostic Regulation, which applied from 26 May 2022.

Since then, the European Parliament has not issued any similar decision regarding the EU In Vitro Diagnostic Regulation.

EU Regulations (No 2017/745 and 2017/746) govern the market access of AI-based diagnostic or treatment systems falling under the definition of medical devices (Présentation du Syndicat National de l'Industrie des Technologies Médicales SNITEM. Catherine Maurain, Fasc. 1-20 : GÉNÉRALITÉS. – Droit pharmaceutique. Mouvements et perspectives, §15).

In 2020, the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) proposed an analytical framework for manufacturers of medical devices utilising AI, particularly those seeking reimbursement from the public health insurance system after prescription (CNEDiMTS, Grille descriptive des fonctionnalités des dispositifs médicaux embarquant un système avec apprentissage automatique (intelligence artificielle)).

European AI regulation is also evolving in terms of risk prevention and addressing damages. On 28 September 2022, two directive proposals were published by the EU – one concerning liability for defective products and another for adapting tort liability rules to the field of AI (Produits défectueux – Responsabilité du fait des produits défectueux et intelligence artificielle : une proposition presque parfaite – Etude par Céline Mangematin. Intelligence artificielle - Responsabilité civile et intelligence artificielle – une proposition de directive européenne a minima? – Focus par Philippe PIERRE). The objective is to ensure that victims of AI-related damages receive the same level of protection as with other technologies.