Surgitrac would like to inform customers of a minor labelling update regarding certain medical devices manufactured by Medicel AG, whose products we supply in the UK.
To align with the latest international standard ISO 15223-1:2021 / Amd 1:2025, Medicel is updating the terminology used to identify the authorised representative on product labelling. The designation will change from “EC-REP” to “EU-REP.”
This update is administrative in nature only and does not impact the quality, safety, performance, or intended use of any Medicel products.
The change will be implemented on a rolling basis. During this transition period, products may be supplied with either designation, as existing packaging stock will continue to be used until exhausted.
All products remain fully compliant with applicable regulatory requirements.
If you have any questions regarding this update, please contact us.
Get in touch
+44 (0) 161 776 7626
info@surgitrac.co.uk
