Advertising your Medical Device in France: Use of Allegations and Comparisons

The ANSM (French National Agency for the Safety of Medicines and Health Products) is clear about it: all allegations and claimed device properties must be backed up by data that objectively justify these claims. It is also important to make sure that these data are in accordance with French medical practice. For example, US hospitalization protocols can be rejected as non-relevant data as they cannot necessarily be replicated in France.

• All statements (except for the technical features) must be accompanied by clear and complete bibliography.

• Studies and research results have to be presented in accordance to strict rules and provide clear, precise, balanced information, divided in homogeneous fields.

• Clinical results, properties and allegations must be backed up by clinical data presented with specific methodology.

• Using clinical data from previous models is possible if the manufacturer can prove that these clinical data are applicable to the newer model, and that during the clinical evaluation of the new device, the equivalence between the two models has been established. Furthermore, the advertisement must mention that the study refers to a previous or similar model.

• On-going studies can be mentioned in the advertisement as long as it is presented in a factual and objective tone. Only studies relevant to the goals specified in the User manual are allowed.

• Comparisons are ONLY allowed in advertisement aimed at professionals. Comparisons are not allowed in advertisement aimed at the general public. Comparisons must be objective and should focus only on features that are essential, measurable, relevant and verifiable.

These are instructions published on the ANSM website that you can visit for more details. Be sure to seek the legal advice of a qualified professional counsel for specific matters.