The draft Act applies to:

- medical devices for human use and their accessories within the meaning of Regulation 2017/745 on medical devices;

- clinical investigations falling within the scope of Regulation 2017/745;

- the groups of products without an intended medical purpose listed in Annex XVI to Regulation 2017/745;

- Chapter 4 also applies to in vitro diagnostic medical devices for human use and their accessories within the meaning of Regulation 2017/746 on in vitro diagnostic medical devices.

PRELIMINARY DRAFT ACT ON MEDICAL DEVICES

The preliminary draft Act supplements and lays down procedures for the
application of Regulation 2017/745 and Chapter IV of Regulation
2017/746.

The articles giving rise to this notification are as follows:

- regulation of devices manufactured and used exclusively in healthcare institutions (Article 7);

- regulation of distance selling (Article 8);

- regulation of custom-made devices (Article 15);

- regulation of clinical investigations (Articles 26, 27, 29, 30, 39, 51 and 54);

- language requirements for notifications (Article 60);

- transitional requirements regarding vigilance (Article 61);

- regulation of advertising for implantable medical devices (Article 83).