Essentials of European Medical Device Regulatory Affairs

Advertising & Promotional Claims of Medical Devices

• Additional to the Medical Device Directive, other provisions on advertising & promotions may be applicable on medical devices by other EU Directives, – Directive 2006/114/EC, concerning misleading and comparative advertising or – Directive 2005/29/EC concerning unfair business-to- consumer commercial practices.

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Advertising Standards Agency (UK)

• The ASA is an independent body that investigates complaints and rules on whether ads should be changed or withdrawn • The Unfair Commercial Practices Directive, is designed to prevent misleading or unfair trading practices. It has been converted into UK law to make sure that we have the same rules as all the other countries in the EU • The ASA works within this legal framework to make sure that UK advertising is not misleading or unfair. The ASA is able to refer advertisers who persistently break the Advertising Codes and don’t work with us to other bodies for the further action, such as Trading Standards

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