The European Commission was mandated and released a draft Commission implementation Decision together with the Annex listing the following four issuing entities designated to operate a system for assignment of UDIs:
(a) GS1 AISBL
(b) Health Industry Business Communications Council (HIBCC)
(c) ICCBBA
(d) Informationsstelle für Arzneispezialitäten – IFA GmbH.
Designation criteria that issuing entities must satisfy are laid down by article 27(2) of MDR and article 24(2) of IVDR.
The designation of entities listed in the Annex should remain valid for 5 years from the date of publication of the finalized Decision. After that, provided that the entities remain compliant with the criteria, the designation should be renewed for a further period of 5 years; or suspended / revoked at any time by the Commission in case of non-compliance with the requirements set forth by the Regulations.
On the process: 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.
We will keep you informed on our News section as soon as the finalized Decision is adopted.
More information on UDIs can be found on MDlaw Library of Documents.
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