Advertising of medical devices

2024-04-02T15:48:00
Spain
CNMC published its report on the draft Royal on advertising of medical devices
Advertising of medical devices
April 2, 2024
  • Pablo García Vázquez
  • The CNMC has recently published its Report on the draft Royal Decree ("DRD") by the Ministry of Health, which proposes a new regulation on advertising of medical devices.
  • The DRD revises and updates the advertising content of medical devices, as well as the administrative procedures that companies must follow to be able to broadcast their advertisements.
  • The CNMC welcomes the fact that the DRD relaxes the requirements for advertising certain medical devices. While it generally requires prior administrative authorization, under the new regulation, certain categories of medical devices (contact lenses, glasses, products for fixing dental prostheses, condoms and pregnancy tests) will only require a declaration of responsibility.
  • The report considers, in line with previous CNMC recommendations, that in vitro self-diagnostic devices such as pregnancy tests and COVID-19 diagnostic tests should not be sold exclusively in pharmacies.
April 2, 2024