System or procedure pack producer

This is a distinct actor role in EUDAMED. If the producer sterilizes the pack, a notified body is involved, and combinations that go beyond the devices' intended purposes are treated as devices in their own right.

For the purpose of this guidance and operations related to EUDAMED, the natural or legal person referred to in Article 22(1), 22(2) and 22(3) of the Medical Device Regulation shall be called the "system or procedure pack producer".

MDCG 2018-3 Rev.1, Section 3.1, Definition of a System or Procedure Pack Producer