We are happy and proud to present our new packaging design for ProLine products.
Although the changes are minor we found it important to share with you that as part of the update, we have left sufficient space on each packaging for a label with UDI* barcode, as well as narrowed the details on the box, all in order to avoid any unexpected difficulties in registration or transportation of the products.
All necessary regulatory changes will be implemented from now on through the products' SDS sheet and IFU (both available on Silmet's website).
*Today, the authorities both in the USA and Europe are addressing UDI by creating legislation, which will require all medical device manufacturers to mark their products with a unique identifier. The EU will incorporate UDI in the revised Medical Device directives and the US FDA is preparing similar legislation. Both participate with other regional authorities in a group which is working to harmonise requirements for UDI globally. By 2018 all devices will be required to have a unique identifier, although in some countries it is already a regulated requirement, which industry should not overlook.