Theme UDI – Systems and procedure pack
Target audience Persons referred to in Article 22 (Systems and procedure pack producer)
Products concerned MD
Regulatory references MDR (EU) 2017/745

Article 22

Article 29(2)

Annex VI Part C points 3.7 and 6.3.1

Documents mentioned MDCG 2018-1 v3

UDIWG 2018-1


This guide provides additional information regarding UDI for systems and procedure pack.

It clarifies when a natural or legal person who assembles MD is not considered a producer of systems and kits, with concrete examples.

It also summarises all the registrations to be made in EUDAMED and the special rules concerning the UDI for systems and procedure pack