Failure to comply with this obligation is punishable under criminal law and liable to a financial fine. The content and the methods of transmission of the summary of the characteristics of the device were fixed by decree in Council of State dated December 13, 2016, canceled on April 26 by the Council of State^(3-4).

1. Annulment of the Decree on Summary of Medical Device Characteristics This decree specified all the elements to be communicated, electronically, to the ANSM, for implantable MDs as well as class III MDs (except custom-made MDs). Seized of an appeal for excess of power by the national union of the medical technology industry (SNITEM) and on intervention of the MedTech association, the Council of State considered that article L. 5211-4-1 of the CSP imposing the transmission of the summary of characteristics to the ANSM is not compatible with the objectives of Directives 90/385 / EEC and 93/42 / EEC relating respectively to in vitro diagnostic MDs and MDs, namely to ensure “complete harmonization of national provisions relating to the placing on the market and entry into service of [MD], in order to guarantee, in compliance with the rules they lay down, the free movement of these devices“. Thus, by instituting an additional obligation prior to the entry into service of certain MDs, accompanied by sanctions, the French legislator has disregarded the objectives of these directives.

The Conseil d’Etat furthermore ruled that 13 decree 2016 could not be considered as allowing for the early application of Article 32 of European Regulation No. 2017 / 745 / EU relating to medical devices, which imposes on manufacturers establish a summary of the safety characteristics and clinical performance and provide it to the notified body involved in the evaluation of the medical device in question for validation before being made available to the public. Since the Regulation, adopted on 5 April 2017, is subsequent to the contested decree and its transitional provisions do not allow derogations from the directives, the contested decree could only have been adopted in violation of the directives. DM manufacturers and agents can therefore breathe a bit before writing summaries of the characteristics of their DMs, within the 2020 horizon according to the Regulations.

2. Increased pressure on price and reimbursement of medical devices

2.1 Communication of reliable economic data under penalty of financial penalties The LFSS for 2018 has granted the Economic Committee for Health Products (hereinafter the “CEPS”) a new power of financial sanction in the event of communication of incorrect medico-economic data⁽⁵⁾. In order to ensure that the CEPS has reliable economic elements enabling it to negotiate the market access conditions of a DM, a financial penalty is imposed on DM manufacturers or distributors and associated services which, in the framework of the registration or the maintenance of the inscription of a product on the LPPR, or within the framework of a negotiation of the price, provide obviously erroneous data notably on the conditions of assumption of responsibility, the volumes of sales or the amounts reimbursed by the health insurance schemes in the other countries of the European Union. The amount of the financial penalty may reach 10% of the turnover excluding taxes realized in France by the manufacturer or the distributor for the last financial year closed for the products in question. Vigilance necessary …

2.2 Extension of the conventional negotiation mechanism with the CEPS Another novelty introduced by the LFSS for 2018, the extension of the conventional negotiation mechanism with the CEPS by which manufacturers and distributors of DM can undertake to pay CNAMTS a discount ⁽⁶⁾ , i.e. a share of the turnover achieved in France on the products concerned by the negotiation. These “price-volume” agreements, which until now only concerned sales volumes, will now also be indexed on more qualitative data, in particular the expenses reimbursed by Health Insurance, the actual conditions of use of the products and services or the levels of recourse within a category of comparable products and services. This device may relate to a specific product or a category of products comparable or meeting similar therapeutic aims, whether MD registered in brand name or MD registered by generic description.

CEPS may also, as is possible for medicines, lower prices and reimbursement rates when a certain amount reimbursed by health insurance under this scheme will be exceeded.⁽⁷⁾.

2.3 Definition of Clinical Evaluation Criteria for DMs Connected by the HAS to Enroll on the LPPR The French National Authority for Health (“HAS”) is currently working on access to reimbursement for connected MDs (“DMCs”), an unquestionably thorny issue. Few are the DM connected today registered on the LPPR. Access to the market and in particular the reimbursement of products requires that the manufacturer of the MD first demonstrate to the National Commission for the evaluation of MD and health technologies (the “CNEDIMTS”) the technical and clinical benefit that his product brings to patients. However, in terms of CMD, this demonstration is particularly laborious in the absence of criteria specific to CMD. The will of the HAS to put in place a methodological guide for clinical evaluation of DMC is therefore beneficial. HAS published on April 23, 2018, a roadmap entitled “Work on the specific methodologies of clinical evaluation of connected medical devices”⁽⁸⁾. This roadmap details the objectives and scope of the work that will be conducted by the HAS in order to identify the particularities of the DMC that must be taken into account during the evaluation of these DM by the CNEDIMTS prior to the procedure of registration on the LPPR for admission to reimbursement. This document specifies that only MDs used for remote medical monitoring or teleconsultation or MDAs generating patient action for the purposes of self-treatment or self-monitoring are covered.

Finally, it should be noted that the entry into force of the General Data Protection Regulation (GDPR) 25 last May will also have a strong impact on the functioning and the constraints on the DMC manufacturers who collect personal health data and must imperatively, if you have not already done so, get in compliance.

3. Supervision of promotional practices in medical devices

3.1 Prohibition to directly cover expenses incurred by health professionals to attend conventions Since the 1^er January 2018, member companies of MedTech Europe can no longer support health professionals to cover their costs of participation in congresses (except training meetings). The only one allowed is the payment, subject to the conclusion of an agreement, of the expenses of health professionals attending the congress as speakers. However, the MedTech Code provides that member companies may subsidize the organizing companies to invite health professionals to participate in a congress, through the conclusion of a donation contract, which must specify that the organization receiving the donation is only master of the choice of participants.

Note that this intermediation practice is not new. To our knowledge, it has in particular been set up within the AP-HP in the field of research where the funding of healthcare industry is centralized by the AP-HP Foundation before being transferred to the research units. The same principle has been tested for covering the costs incurred by AP-HP hospital doctors to go to congresses by certain manufacturers, the “congress budget” being entrusted to a third party responsible for selecting and organize the care of the participating doctors.

3.2 Creation of a promotional information charter for non-prescription health products Promotional practices relating to DM, so far little framed, have been the subject of renewed interest from the public authorities for several months. While the Promotional Information Charter signed between the LEEM and the CEPS in 2014 only deals with MDs when it comes to submitting samples during the presentation of medicines, the LFSS for 2018 came to equip the DM sector. of its own promotional information charter⁽⁹⁾. CEPS and the representative organizations of manufacturers or distributors of MD and products registered on the LPPR are invited to negotiate and conclude a “quality charter for the professional practices of persons responsible for the presentation, information or promotion of medical devices for individual use, non-prescription health products and any associated services and adaptation services“.On the calendar side, this charter must be concluded before September 30, 2018 and approved by the ministers responsible for health and social security. Otherwise, it will be arrested by the said ministers. If nothing is, to our knowledge, signed with the CEPS, the SNITEM would however have concluded with the AP-HP, on April 18, 2018, an agreement aimed at supervising promotional activities, within its 39 hospitals, visitors acting for companies marketing MDs. This convention defines in particular the conditions under which medical visits can be organized within the AP-HP and impose a referencing of “technical sales agents” Likely to access AP-HP hospitals ⁽¹⁰⁾. This approach is part of the program to combat conflicts of interest, in the same way as the establishment of intermediation in relations with manufacturers presented above. To complete this system, article 58 of the LFSS clarified and completed the missions of HAS in terms of certification to presentation, information and promotion activities, HAS now having to establish a certification procedure with the aim of guarantee compliance with the medical examination charters “pharmaceutical specialties” and “ medical devices and other health products “⁽¹¹⁾. La volonté de procéder à une harmonisation des pratiques promotionnelles relatives à tous les produits de santé remboursés est ici flagrante. Pas de jaloux !

Note that only manufacturers or distributors of DM registered on the LPPR are invited to negotiate. It is therefore reasonable to think that only the reimbursable DM will be covered by the Charter. We can clearly see here the economic logic underlying this legislative provision and which justifies its place in the social security financing law..

3.3 Management of the evolution of the promotional practices of the products under penalty of financial sanctions The CEPS may also set quantified targets for the evolution of commercial, promotional, presentation or information practices, for certain products or for a set of products⁽¹²⁾. In case of non-compliance with these quantitative objectives or non-compliance with the provisions of the charter, the CEPS is authorized, after having allowed the company to submit its observations, to impose a financial penalty of up to 10% of the figure. duty-free business carried out in France by the company in respect of the last financial year closed for the product or services concerned by the breach. A decree in Council of State, not yet adopted to our knowledge, should specify the conditions in which the CEPS will note the breaches of the charter⁽¹³⁾.

3.4 Extension of certification missions for HAS prescription and dispensing software to DM functions Finally, the HAS also sees its mission of certification of medical prescription aid software (“LAP”) and dispensing assistance software (“LAD”) extended to functions relating to MD and associated services, previously limited drugs. In addition, it is responsible for approving MD databases and associated services used by LAPs and LADs, like the existing mechanism for medicines. This approval as well as the related certification will be made compulsory under the conditions provided for by decree of the Council of State and no later than 1^er January 2021 for any LAP or LAD which at least one of the features is to offer assistance with the edition of prescriptions and the issuance of DM and associated services. For the record, the Court of Justice of the European Union⁽¹⁴⁾ held, on a preliminary question from the Council of State, that a LAP, “One feature that allows the use of patient-specific data for the purpose of, among other things, detecting contraindications, drug interactions, and excessive dosing, is a medical device for this feature. (…) even if such software does not act directly in or on the human body“. Consequently, this software is subject to compliance with the regulations on MDs, in particular Directive 93/42 / EEC.

Thus, the LAP certification scheme introduced by the legislator, in that it introduces an additional constraint to the manufacturers of these DM, could be judged by the Council of State as incompatible with EU law and in particular with the objective of free movement of goods. The Council of State seized of the question has, to our knowledge, not yet rendered its decision.

The regulation of DM, which is becoming increasingly restrictive, is moving towards harmonization with the regulation of medicines. However, the diversity of DM as well as the very innovative and innovative character of some of them – evidenced by the many artificial organs that arrive on the market (hearts, hands, pancreas …) but also artificial intelligence devices – generate new regulatory and liability issues that the current texts do not necessarily address.

Open questions for manufacturers and a challenge for French and European institutions in perspective …