Sandrine de Sousa on the Medical Device Charter: a commitment to quality and safety

Sandrine de Sousa on the Medical Device Charter: a commitment to quality and safety

The quality and safety of healthcare products are key issues for the pharmaceutical industry. To ensure optimal patient care, the entire sector must comply with strict regulations and directives, particularly regarding medical devices. In this context, the quality charter for professional practices of those responsible for presenting, providing information on, or promoting medical devices for individual use plays a vital role.

In accordance with the Social Security Financing Act for 2018, the charter aims to regulate commercial, promotional, presentation and information practices relating to products, on the one hand, and to the services associated with these products, on the other hand.

The charter has been immediately implemented since its publication at the Olympic Games on March 8, 2022, recalls Sandrine De Sousa, quality and legal director of a major drug manufacturer during her interview with Pharmaceutique magazine.

This charter is intended to strengthen the quality of professional practices of those responsible for promoting, presenting or providing information on products, on the one hand, and services, on the other hand, to ensure quality information, proper use and proper prescription to professionals, whether health professionals or not, authorized to prescribe, purchase or use the products or associated services.

A significant change introduced by the charter requires companies to report promotional visits made to healthcare professionals on the CEPS platform : nature of the visit, people met, dates and methods, medical device and therapeutic area concerned. Sandrine De Sousa emphasizes that "this frequency applies per professional in the community and per department in the hospital, which represents a significant change."

"On March 1, Pharmafield organized a meeting on the charter for the promotion of medical devices , a counterpart to that of drugs (released in 2014), which will revolutionize the practices of more than 3,000 operators, distributors, and service providers in France. "The application has been immediate since its publication in the Olympic Games on March 8, 2022," recalls Sandrine De Sousa, its quality and legal director/compliance officer. Companies must declare their visits to healthcare professionals on the CEPS platform: nature of the visit, people met, dates and methods, medical device, and therapeutic area concerned. A maximum number of visits is set per year, for the same professional and per company. "This frequency applies per professional in the community and per department in the hospital, which represents a significant change," she points out. Pharmafield is therefore adapting internally to record these visits and establish an alert system for delegates and managers."

In accordance with the Social Security Financing Act for 2018, the charter aims to regulate commercial, promotional, presentation or information practices relating to products, on the one hand, and to the services associated with these products on the other hand, as mentioned in Article L. 165‑1 of the Social Security Code (CSS), in order to guarantee that these practices cannot harm the quality of care or lead to unjustified expenditure for compulsory health insurance.

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