Module 17 2024

03/12/2024

EU harmonisation for medical devices advertising

The Organisation for Professionals in Regulatory Affairs

TOPRA MSc Module 17

31

Is there a harmonised approach to medical device advertising?

• Harmonisation across EU is not complete

• MS divergences around, e.g.:

• Advertising regarding specified disease states

• Inclusion of mandatory “PI” -type information (e.g. side effects)

• Need for pre-vetting or authorisation by regulators

• DTC advertising for professional-use products

• DTC advertising for reimbursed products

• Specific requirements relating to UGC

The Organisation for Professionals in Regulatory Affairs

TOPRA MSc Module 17

32

16