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Unique identification of medical devices (UDI): Agreed terms

Please complete this declaration if you are using your GS1 Ireland License to identify products which are classified as Medical Devices in the US under the FDA UDI Rule. 

1. Interpretation


1.1 All capitalised terms used in these Service Contract Terms and Conditions which are not defined in these Service Contract Terms and Conditions shall have the meaning given to those terms in the Framework Agreement:


“UDI”means unique medical device identification;
“Medical Device”   means a product that may be characterised as a medical device under the laws of the country where such product is marketed, in this case as defined by the Food and Drug Administration (FDA) for the US market;
“Deficiency” means any of the following: a misconstruction of the identifier, a mismatch between the name of the company holding the license for the GS1 Key and the company using the GS1 Key or any other inaccurate, incomplete or outdated information;
“Correction Period” means a period of 90 days that is allowed to correct a Deficiency from the date of notification;

2. Services


2.1. The Member understand that GS1 Ireland is a member of the global GS1 organisation, which has been accredited by certain regulatory agencies as an issuer of UDIs and, in that capacity, both are subject to certain regulatory obligations, including but not limited to reporting of companies that use the GS1 standards for UDI.


2.2. The Member understands that when it uses GS1 Keys to identify a Medical Device, the following rules shall apply:


a. upon applying for a licence, the Member must inform GS1 Ireland if a GS1 Key will be used to identify a Medical Device and in which country the related product will be marketed;


b. the Member is and shall at all times remain responsible for the information about the Medical Device provided by it to GS1 Ireland and for compliance with any applicable regulatory obligations, and shall ensure any information provided to GS1 Ireland is accurate and up-to-date at all times;


c. GS1 Ireland may monitor correct implementation of the GS1 Standards by the Member;


d. in case GS1 Ireland identifies a Deficiency, GS1 Ireland may inform the Member in writing (addressed to the Member’s usual contact person) of such Deficiency, suggesting a way to correct the Deficiency and requiring the Member to correct such Deficiency within 90 calendar days from the date of the notification;


e. GS1 Ireland may monitor whether the Member has corrected a Deficiency within the Correction Period. Failing such correction, at the latest eight (8) calendar days after expiry of the Correction Period, GS1 Ireland may contact the Member again and seek to amicably resolve the Deficiency;


f. if the Deficiency is not corrected within an additional period of 90 days from the expiry of the Correction Period and pertain to a repeated and/or deliberate misuse of the GS1 Standards related to UDI, GS1 Global Office, working with GS1 Ireland, may inform the regulator and modify the use (including suspension and revocation) of the GS1 Company Prefix for UDI implementation in the relevant jurisdiction, as a follow-up action taken in cooperation with the relevant regulator;


g. the Member acknowledges and agrees that GS1 Ireland must, in the context of its regulatory obligations, share certain information with the relevant regulators either directly or via GS1 Global Office, including but not limited to the fact that the Member uses the GS1 Keys to identify Medical Devices marketed in the regulator’s country, the GS1 Keys, the name of the Member’s company, as well as any identified and uncorrected Deficiencies. The Member understands that neither GS1 Ireland nor GS1 Global Office may be held liable for any direct or indirect consequences, losses or damages resulting from GS1 Ireland and/or GS1 Global Office providing such information to a regulator