|Target Audience||Manufacturers, Person designated in article 16(1) of the MDR|
|Products Concerned||Class I MD|
|Regulatory reference||MDR (EU) 2017/745
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.