1

Advertising of Medical Devices

28th Meeting of CAMD, 27-28th 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