New Law in France Targets Advertising of High-Risk Medical Devices
On 1 January, 2013 France implemented a new law which regulates the advertisement of several high-risk medical devices and IVDs to healthcare professionals. The new law also applies to dermal fillers and IVDs (intended for self-testing) that are advertised to the public. Devices falling under the new law include cardiovascular implants, coronary and intracranial stents, and breast implants.
According to the new requirements, manufacturers must secure approval from Competent Authority ANSM before disseminating advertising material related to the sale or promotion of targeted devices in France. The aim of the law is to strengthen public safety by controlling statements made in advertising prior to their release.
To obtain approval from ANSM, manufacturers must submit their advertising material for review. If a manufacturer receives no questions or objection within two months, approval is granted and remains valid for five years. Subsequent changes to approved advertising material that affect product claims or a medical device's reimbursement status in France will require a new application. (Minor changes are allowed but must be notified.)
For more information about which devices are affected by the new law, please visit the ANSM web site (in French).