A new law in France will regulate marketing and advertising of high-risk medical devices. According to a report by the Emergo Group, the law will impact manufacturers of cardiovascular implants, intracranial stents, coronary stents and breast implants.
The new rules became active on January 1 of this year. Before starting a marketing or advertising campaign, companies that fall under the rule must obtain approval from the Competent Authority (ANSM). To obtain marketing approval with the ANSM, medical device manufacturers must submit a copy of the relevant advertising materials.
If a medical device manufacturer doesn’t receive further questions from the ANSM within two months, it will be allowed to use those advertising materials. Once approval is granted, advertising is valid under the new law for up to five years. Significant changes in a company’s advertisements will require a new application. In addition, changes in a medical device’s reimbursement status in the country will require a new application with the ANSM.