UDI designating entities: EU Commission implementing decision released
On the 7th of June 2019, the European Commission released an Implementation Decision listing the issuing entities designated to operate a system for assignment of Unique Device Identifications (UDIs). In fact, Regulation (EU) 2017/745 on Medical Devices and Regulation (EU) 2017/746 both envisage a UDI system, respectively in articles 27(1) and Article 24(1).
Criteria that issuing entities must satisfy to operate a system for assignment of UDIs are laid down by article 27(2) of Regulation (EU) 2017/745 and article 24(2) of Regulation (EU) 2017/746. A call for applications was launched on the EU Commission’s website on 21 December 2018, with the deadline of 25 January 2019. The European Commission has evaluated the applications received, consulting the Medical Device Coordination Group (MDCG) on the matter as well, that did not raise any objection.
The EU Commission has listed in the Annex to the Decision the following four entities, after reviewing four applications, that were all deemed to be satisfying:
(a) GS1 AISBL
(b) Health Industry Business Communications Council (HIBCC)
(d) Informationsstelle für Arzneispezialitäten – IFA GmbH.
The designation of the above listed entities should remain valid for 5 years – until 27 June 2024. After that, provided that the entities remain compliant with the designation criteria, the designation should be renewed for a further period of five years. The designation could be suspended or revoked at any time by the Commission in case the entities are not compliant anymore with the requirements set forth by the Regulations.
July 10, 2019
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