Commission Implementing Decision 2019/939 on UDIs for Medical Devices
Pierre Mermet-Bouvier
eCOAs I Regulatory Affairs I Transparency I PMO I Regulatory Intelligence I Clinical Operations I Global and Transversal Teams I Process Improvement I Operational Excellence I Strategic Planning
The 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 was published last week in the Official Journal of the European Union.
The 3-page Decision lists in the Annex the 4 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. It can noted that the Commission received only four applications and all satisfied the relevant criteria for designation under both Regulations.
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2019.149.01.0073.01.ENG&toc=OJ:L:2019:149:TOC