Medical Devices: Now Introducing the Medical Visit Charter!

The Medical Device (MD) and In Vitro Diagnostic Medical Device (IVDMD) sector is subject to increasingly stringent regulations. CE marking, the replacement of European Directives 93/42 and 98/79 with Regulations (EU) 2017/745 and 2017/746, anti-gift laws, and transparency measures are all part of the strict framework governing this field. In 2022, a new French requirement emerged with the medical visit charter, established by the decree of March 4 and published in the Official Journal on March 8. This charter stems from the 2018 Social Security Financing Act (in French Loi de Financement de la Sécurité Sociale, LFSS), specifically Article L.162-17-9of the Social Security Code.

Its implementation addresses growing concerns about transparency and ethics in interactions between healthcare professionals and medical product companies. Inappropriate practices and a lack of transparency have made strict regulation necessary to ensure ethical and transparent interactions.

To understand the scope of this charter, it is essential to consider for whom it is intended, the practices it governs, and the modalities of its implementation.

A charter for whom?

The meetings organized between representatives of medical product companies (delegates) and healthcare professionals, known as “medical visits,” are privileged moments. During these exchanges, medical delegates present and promote their devices while providing essential information on their use. The goal is to raise awareness among healthcare professionals about new products, provide clinical and technical data, and answer their questions to promote appropriate and safe use.

Some of these devices, as well as associated services, are covered (partially or entirely) by health insurance and are listed on the list of reimbursable products and services (in French Liste des produits et prestations remboursables, LPP) provided for in Article L.165-1 of the Social Security Code. They fall within the scope of this charter, along with all actors responsible for their promotion and presentation. Finally, the beneficiaries of these visits include all professionals authorized to prescribe, use, or purchase these products, whether they work in heathcare institutions, city healthcare establishments, or community pharmacies.

It should be noted that this practice is not unique to France; other European countries, such as Germany and Italy, also impose regulations on this activity.

Presentation, Promotion, Information

The charter requires rigorous organization of medical visit activities, particularly in terms of duration and frequency. All visits must be recorded and documented annually on a soon-to-be-available secure digital platform provided by the Health Products Economic Committee (in French Comité économique des produits de santé, CEPS). Each company is limited to four annual visits, excluding specific activities such as vigilance, tenders, or training. This frequency may be reevaluated after the initial experience with the charter’s application.

Prior appointment scheduling is mandatory. Medical delegates must wear visible professional badges and adhere to strict ethical rules, including professional secrecy and discretion. Employers are also required to maintain the competencies of their medical delegates and comply with transparency obligations.

The charter emphasizes the quality of the information provided, requiring accurate and up-to-date data that takes into account scientific, medical, and regulatory developments. Promotional materials must comply with ANSM recommendations (competent authority in France) and the requirements of Decree No. 2012-743 of May 9, 2012, on medical device advertising, as well as various related orders, decisions, and ordinances published after this date.

Impact on Quality Management Systems and Certification

A Quality Management System (QMS) must also be implemented within companies to ensure compliance with the charter. This system aims, for example, to guarantee the content, dissemination, and traceability of presentations and other materials available or provided to healthcare professionals.

To consider these new requirements, the creation or update of an existing QMS is significant and requires the following major elements:

• Strengthening regulatory compliance (promotion),
• Improving transparency and ethics,
• Increased training and awareness of medical delegates,
• Collecting and recording customer feedback,
• Traceability…

Finally, it will also be necessary to obtain certification according to a new standard that is presently being drafted by the Haute Autorité de Santé (HAS) to ensure compliance with this charter.

Participants of the Standard and Detection of Non-compliance

The HAS launched a call for applications at the end of 2023 (end on January 15, 2024) to develop a certification procedure for the presentation, information, and promotional activities of health products and services. The aim is to form a working group composed of qualified experts in this field. The next steps include drafting, reviewing, and validating the resulting standard. The official publication in the Official Journal is scheduled for March 4, 2025 (details here).

In case of non-compliance, the CEPS, responsible for enforcing this charter, can impose a financial penalty on non-compliant companies equivalent to 10% of their pre-tax revenue generated in France. A penalty grid based on the nature and frequency of deviations will be published soon. Non-compliance can be detected through inspections conducted by the CEPS or by notifying non-compliance via the dedicated secure platform.

Conclusion

The publication of the medical visit charter marks a crucial step in regulating the medical devices sector in France. By imposing stringent requirements for transparency, ethics, and compliance, this charter aims to strictly oversee interactions between medical delegates and healthcare professionals.

Ultimately, it not only regulates but also encourages companies to adopt a proactive approach to quality, transparency, and responsibility, thereby contributing to better patient protection and safer use of medical devices.

Why Seek Assistance from Our Efor Experts?

Our experts in regulatory affairs and quality management systems can offer tailored assistance to meet your needs on the following topics (non-exhaustive list):

• Integrating the charter’s requirements into your QMS,
• Evaluation of the compliance of your promotional materials and claims (clinical and non-clinical),
• Understanding the anti-gift mechanism and transparency obligations,
• Training on applicable regulations regarding MD and IVDMD advertising.

Our teams are at your disposal to answer your questions.