Marketing Guidelines for advertisement of medical device aimed at the general public in accordance to the Loi Bertrand
The National Agency for the Safety of Medicines and Health Products (ANSM) is the French agency responsible for conformity checks on advertisement in the medical field.
The rules applicable to the advertisement of medical devices in France differ depending on the type of device and on the target audience (general public or professionals). Depending on these 2 categories, advertising may require previous authorisation delivered by the ANSM called a “Visa” (See our previous article on the Loi Bertrand).
The legal framework for medical advertisement aims at protecting patients’ safety and guarantee transparency.
The ANSM issued, within that framework, guidelines to outline the basic requirements and restrictions of the Loi Bertrand in regard to advertisement aimed at the general public.
Make medical consultation or surgical intervention look unnecessary especially by offering a remote diagnosis
Provide a detailed description of symptoms that could lead to a false auto-diagnosis
Suggest that the device’s effects are guaranteed or without side-effects
Compare the device’s results with those of other treatments or devices
Suggest that the efficiency or safety of your product is linked to its natural ingredients
Suggest that a normal state of health can be improved by the use of the product or can be affected by the lack of it
Use any elements aimed exclusively or primarily at children
Refer to recommendations from scientists or healthcare professionals
Refer to any person of influence who could encourage the use of the product (Class IIb and III, AIMD)
Assimilate the device to food, cosmetics, or any consumer product
Do not use visual representation of an altered human body due to disease, injury, or handicap improperly, nor in a misleading or frightening way
Present in an exaggerated or misleading manner the effect of the device on the human body
Refer to healing claims (for example patients’ testimonies or pictures showing patients “before and after” the treatment
Insist on the fact that the device has been certified
Mention any premium offers, free gifts, or any marketing products, nor any material benefits offered directly or indirectly (Class IIb and III, AIMD)
Mention partial or full reimbursement by French Social Security or by any supplementary health insurance (Class I and IIa)
In addition to these restrictions, advertisement aimed at the general public must include mandatory mentions, displayed legibly and visibly, using a font as large as possible (min. 9, non-condensed) and in a colour that contrasts with the background.
Denomination or trade name
The manufacturer’s name or the authorised representative
An invitation to carefully read the instructions in the user manual or on the label
A caution statement, depending on the degree of risk to human health
Indispensable information to ensure good use
Reference to the advice of a physician, pharmacist or any professional duly qualified in regard to the nature of the MD
The French CE declaration: "Ce dispositif médical est un produit de santé réglementé qui porte, au titre de cette réglementation, le marquage CE"
Date of production or last modification
If the advertisement is subject to an authorisation, the internal reference number
These are the main instructions issued by the ANSM.
For any complementary information or particular cases, be sure to seek the legal advice of a qualified professional counsel on this specific matter.
The Don't's: https://www.ansm.sante.fr/Activites/Publicite-pour-des-dispositifs-medicaux-et-dispositifs-medicaux-de-diagnostic-in-vitro/Recommandations-pour-la-publicite-des-DM-DMDIV/Recommandations-pour-la-publicite-des-DM-DMDIV/Quelles-regles-sont-specifiques-aux-publicites-aupres-du-public
Mandatory mentions: https://www.ansm.sante.fr/Activites/Publicite-pour-des-dispositifs-medicaux-et-dispositifs-medicaux-de-diagnostic-in-vitro/Recommandations-pour-la-publicite-des-DM-DMDIV/Recommandations-pour-la-publicite-des-DM-DMDIV/Quelles-mentions-doivent-obligatoirement-etre-apposees-sur-les-publicites