Commission Implementing Decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices (Text with EEA relevance.)

• CELEX: Implementing Decision (EU) 2019/939
• Articles: 4

Article 1 Designation of issuing entities

The issuing entities listed in the Annex to this Decision are designated to operate a system for assignment of UDIs pursuant to Regulation (EU) 2017/745 and to operate a system for assignment of UDIs pursuant to Regulation (EU) 2017/746.

Article 2 Terms of designation

1.   The designations made under Article 1 shall each remain valid for a period of five years from 27 June 2019. At the end of that period, each of those designations may be renewed for a further period of five years if the issuing entity remain in compliance with the criteria for designation and the terms of designation.

2.   The Commission may suspend or revoke the designation of an issuing entity under Article 1 at any time if it finds that the entity no longer satisfies the criteria for designation, laid down in the first subparagraph of Article 27(2) of Regulation (EU) 2017/745 or in the first subparagraph of Article 24(2) of Regulation (EU) 2017/746.

Article 3 Entry into force

This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX

ANNEX

List of issuing entities designated to operate a system for assignment of UDIs pursuant to Regulation (EU) 2017/745 and a system for assignment of UDIs pursuant to Regulation (EU) 2017/746

(a)

GS1 AISBL

(b)

Health Industry Business Communications Council (HIBCC)

(c)

ICCBBA

(d)

Informationsstelle für Arzneispezialitäten — IFA GmbH