| Theme | Marketing |
| Target Audience | Manufacturers, Person designated in article 16(1) of the MDR |
| Products Concerned | Class I MD |
| Regulatory reference | MDR (EU) 2017/745
Article 16(1) |
| Documents mentioned |
This document provides a summary of the regulatory obligations wich are incumbent on class I MD manufacturers (as well as persons referred to in section 16(1) of the MDR who make Class I MD available). Please note that this guide does not deal with custom-made Class I MD.