1.Gain GS1 Switzerland membership
To use GS1 standards, you need membership with use of the GS1 System (barcodes).
2. Assignement of a Basic UDI-DI
The MDR and IVDR define the Basic UDI-DI as the primary identifier of the device model, which is assigned at the level of the unit of use. It is the main key for records
in the UDI database and is referenced in relevant certificates and EU declarations of conformity. Use the GMN – Global Model Number -
for assignment of the Basic UDI-DI.
3. Assignement of UDIs
3.1. General requirements
The manufacturer assigns one-off UDIs for his medical devices and maintains these. The UDI may only be placed on the medical device or its packaging by the manufacturer. A UDI is
assigned to the medical device itself or its packaging. Higher packaging levels have their own UDI. Each component which is considered a medical device and is commercially available on its own is assigned a separate
UDI, unless the components are part of a configurable medical device which is labelled with its own UDI. Shipping containers are excluded from these requirements. The GTIN Registry and MyGTIN help you to organise your
3.2. The DI unit of use
The DI unit of use is used to assign the use of a medical device to a patient in cases where the UDI is not indicated on the individual medical device at the level of
its unit of use, e.g. if several units of the same medical device are packaged together. To identify your units of use, use the GTIN – global trade item number.
The UDI-DI is a one-time numeric or alphanumeric code which is unique to a medical device model and is also used as 'access key' to information stored in a UDI database. The UDI-DI is unique at
all levels of product packaging. To identify your medical devices and the available packaging levels, use one GTIN - global trade item number - each. Please note the relevant assignment and update rules (see MDR/IVDR
Annex VI, Part C (3) and (6)) when assigning all identification numbers. These are enshrined in the MDR and IVDR on the one hand and on the other, there are GTIN assignment rules for healthcare.
The UDI-PI is a numeric or alphanumeric code used to label the unit of device production. The different types of UDI-PI include serial number, lot number, software identification and the manufacturing
or expiry date, or both. If a lot number, a serial number, software identification or an expiry date is indicated on the label, it is part of the UDI-PI. If the date of manufacture is also included on the labelling,
this does not need to be incorporated in the UDI-PI. If only the date of manufacture is on the labelling, this must be used as UDI-PI. Use the GS1 application identifier (AI) for this purpose.
4. Selecting the appropriate UDI carrier
In principle, the requirements for UDI carriers listed in the MDR/IVDR must primarily be followed. They are provided in MDR/IVDR Annex VI Part C (4).
The following GS1 barcodes are permitted as UDI carriers:
RFID technology may also be used for the 1D or 2D barcodes. GS1 supports two frequency ranges – ultra high frequency (UHF) from 860 to 960 MHz and
high frequency (HF) at 13.56 MHz.
5. Uploading UDI data to EUDAMED
You will need the Basic UDI-DI and all UDI-DIs generated as well as the associated medical device data prior to launch, in order to register your medical
devices in the European database on medical devices (EUDAMED – see MDR/IVDR Annex VI Part A). You then continuously update this information. To date, no notification regarding the full functioning of EUDAMED has
been published by the European Commission in the Official Journal of the European Union, which means that registration currently is not possible. However, you can already prepare data exchange as per the UDI regulations