1 Advertising of Medical Devices 28 th Meeting of CAMD, th October 2011, Poland, Cracow Ellen Jespersen, Head of Department for Medcal Devices

2 Advertising of medical devices Current status Danish national legislation Challenges

3 Current status No common EU legislation in regards to medical devices exist National legislation exists

4 What is advertising? Advertising means any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medical devices.

5 What is not advertising? The labelling and instructions for use Individual correspondence – answering questions Necessary and concrete information serving safety purposes Information material about health and diseases provided that specific medicinal devices are not mentioned neither directly nor indirectly. Press releases

6 General provisions must be adequate and objective must not compromise safety and health the information given must be compatible with the intended purpose must not contain misleading or exaggerating information factual information must be backed up by documentation

7 The advertisement must not…….. give the impression that it is unnecessary to consult a doctor,…. give the impression that use of the device is not associated with any risk suggest that the health of the person can be deteriorated by not using the medical device be exclusively or principally directed at children give information that could lead to erroneous self diagnosis use, in improper, alarming or misleading terms pictures or drawings

8 The advertising to the public must not….. make recommendations by healthcare professionals, scientists or persons who, because of their prestige could encourage use neither directly nor indirectly, mention serious diseases refer to analysis, literature, journals

9 Challenges Via internet pages hosted outside Denmark, products can be advertised towards the Danish public –not in compliance with Danish advertisement legislation –not in compliance with Danish language requirement of packaging Lack of common legislation in the EU possibly complicates the free movement of goods

10 Thank you