Originally published as Covington E-Alert on February 13, 2012

New Advertising Rules

Medicinal and Health Products (“loi relative au renforcement de la sécurité sanitaire du médicament et des produits de santé”) (the ‘New Law’) will have a tremendous impact on the medical devices industry. The industry will now be subject to new advertising rules, sunshine-like obligations, stricter rules on conflicts of interest, and more.

A new chapter on advertising rules for medical devices has been inserted in the Public Health Code (‘Code de la santé publique’ or CSP) (Art. L. 5213-1 to L. 5213-7). In some aspects, the new legal regime is similar to the one for medicinal products: prohibition of advertising for non-CE marked devices; prohibition of advertising to the general public for medical devices subject to health insurance reimbursement, except for medical devices with a low risk to human health; prior approval for advertising for medical devices with an important health risk; and general criteria for advertisements. Violations of those rules by manufacturers, EU representatives, or importers are administratively and criminally sanctioned.

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