Meet International Regulations
Mediclabel is an asset for healthcare organizations looking to use the GS1 standard to meet international legislations such as the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR).
Examples of clients that use Mediclabel are Amsterdam UMC, Curan Catheters, Erasmus MC and Endoss. Using the latter two clients as an example, we’ll illustrate the various possibilities of Mediclabel.
In general, Mediclabel was created to help manufacturers and healthcare institutions label their medication, medical devices, locations, patients, assets and even their staff with GS1 barcodes.
Comply with MDR
With Mediclabel manufacturers can assign a UDI for (the packaging of) medical devices and in some cases on the medical device itself. The deadline for UDI assignment of medical devices (class III) was 26 May 2021. New European rules will apply to in vitro diagnostics (IVDR) from 26 May 2022. We recommend you put UDIs on medical devices a soon as possible so healthcare institutions can scan your products.
Mediclabel is a user-friendly application, accessible through the web or on-premise. Each client has their own secure environment, with the possibility of multiple locations that are managed centrally. User actions such as label generation are completely traceable.
A Mediclabel subscription comes with an unlimited number of users and labels, user management is available per location and user come in two variants: operator and administrator. Meaning you are in control of who has clearance to add and edit products and who only needs the option to generate a label.
Endoss and Mediclabel
As GS1 partner we help producers and wholesalers implement the GS1 standard and meet various international legislations. Endoss, supplier of disposables, uses the online version of Mediclabel to label their products with a UDI (Unique Device Identifier). As a supplier of low risk items, Endoss is one step ahead of the upcoming MDR regulations.
Complying with MDR-regulations
The Medical Device Regulation (MDR) states that manufacturers of certain medical devices are obliged to uniquely encode their products with a UDI. Making easily identified and traced medical devices a reality. More and more healthcare institutions are asking their supplier to supply all their products with a standard barcode.
UDI and DataMatrix
Endoss marks each of their products with a UDI, using Mediclabel. Their UDI label includes a unique identification code in the form of an GS1 product code called the GTIN, as well as a batch number and the expiration date. This information is present in text and in barcode form as a GS1 DataMatrix. Endoss chose the DataMatrix symbology for their barcode, because it can contain a lot of data without losing the ability to fit in a small space. Thus, fitting optimally on their product packages.
Endoss is at the forefront with this and gets positive reaction from their customers, who are happy to be able to already scan their products. By supplying al their packages with a UDI label, Endoss can deliver products worldwide. With Mediclabel, powered by T2S, they meet the GS1 standard and future law and legislations.
Intrigued and want to know more?
Do you have specific questions, or would you like an appointment for a demonstration? Don’t hesitate to contact the Mediclabel team by phone at +31 180 545151 or drop us an email: email@example.com. We’re happy to help!