Declaration of Conformity (DoC)

As a general requirement, the manufacturer of medical device or accessory in compliance with the applicable requirements of MDR 2017/745 must declare the conformity with an EU DoC (Article 19 in combination with Annex IV of MDR 2017/745). The medical devices and accessories must be covered with a single Basic UDI. The Basic UDI must be identified on each EU DoC (see Annex IV, Section 3 of MDR 2017/745).

For system or procedure packs article 22 of MDR 2017/745 is applicable. Those system or procedure packs are required to be aligned to a UDI (see Annex VI, Part C, Section 6.3.1). The assignment of a Basic UDI for a system or procedure pack (as defined in Article 22) is identified in Article 29, Section 2 of MDR 2017/745.

For system or procedure packs, a statement according to Article 22, Section 2 has to be created. Please check whether the devices are covered by Article 22 of MDR 2017/745, or not.