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
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).