| Theme | Borderline between medical devices and medicinal products |
| Target Audience | Manufacturers |
| Products concerned | Borderline products |
| Documents mentioned |
Directive 2001/83/EC Regulation (EU) 2017/746 Directive 93/42/EEC Regulation (EU) 528/2012 Directive 2004/27/EC Regulation (EC) 726/2004 |
This guide deals with borderline devices, which are defined as products for which it is not clear from the outset whether they are governed by the DM Regulation or by another regulation.
Different chapters are dedicated to herbal products, substance-based devices and combinations of medical devices and medicines.
Finally, flowcharts are provided to assist manufacturers in determining the status of their products.