Medical Device Advertising Requirements in United States
According to the MDD, only medical devices that carry the CE mark can be advertised or promoted in the EU. The directive also made it clear that only medical devices that complied with requirements can be advertised.
Advertising should be in accordance with its intended purpose “according to the data supplied by the manufacturer on the labelling, in the instructions, and/or in promotional materials.”
The MDR distributor expanded this to include “as specified by the manufacturer in the clinical evaluation.” This means that if a marketing team makes a claim about a medical device, it should be backed by clinical data. Advertising should always center on the medical device’s intended purpose.
Each of the 27 countries under the EU has its own laws regarding advertising. However, there is a universal sentiment that marketing initiatives and promotional materials should not be misleading.
