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.