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  • X40M - Etikettierung und Werbung

Advertising of devices Article 1(4) of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ EU L 117 of 5.5.2017, p. 1, as amended), and devices referred to in Article 1(2) of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ EU L 117 of 5.5.2017, p. 176, as amended).

Draft Regulation of the Minister for Health on advertising of medical devices

The draft regulation sets out:

1) the necessary data contained in the advertising made available to the public – to ensure that the recipients are given adequate knowledge of the device advertised, and which will be included in the instructions for use and the label of the device;
2) the manner of presenting advertising of medical devices – analogous to the forms of presenting advertising of medicinal products together with an appropriate warning issued or placed together with advertising and limiting forms of advertising in pharmacies, pharmacy outlets, non-pharmacy outlets and medical entities in order to enable the proper provision of services in these places.
In order to ensure transparency with regard to the advertising of medical devices, § 4 of the draft Regulation lays down an obligation to indicate that the communication is advertising.