Unique Device Identification

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 GTINs.

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.

3.3. UDI-DI
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. 

3.4. UDI-PI
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:
-GS1-128
-EAN-13 Barcode
-GS1 DataMatrix

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 today.

Valid from

The new Medical Device Regulation (MDR) has been postponed by one year as per the resolution of the European Commission of 17 April 2020 and will come into force on 26 May 2021.

The Mutual Recognition Agreement (MRA) between Switzerland and the European Union has also been postponed by a year. Accordingly, MDD medical devices and MDR medical devices may be launched in the EU internal market until 26 May 2021 (without third country requirements).

Click here for the official publication in the Official Journal of the European Commission.

UDI-carrier on label

As of 26 May 2021, placing a UDI carrier on the labelling of your medical devices and at all higher levels of packaging (excluding shipping containers) will be according to assessment of the medical device in one of the following risk classes:

Risk class

Due to a missing MRA (Mutual Recognition Agreement) between Switzerland and the EU, there are particularities for the Swiss market, which have to be considered as a manufacturer, importer or distributor of medical devices.

In Switzerland, the MedDo version of July 1, 2020 (as of May 26, 2021), which only partially adopts European law, has been in effect since May 26, 2021.

The missing MRA affects both imports and exports of medical devices. We focus our communication on imports. For exporting companies, the industry association SWISS MEDTECH has published detailed information.

The communication of the EU and also Switzerland repeatedly refer to the fact that talks are still ongoing and possible developments would be communicated. We will inform you as soon as possible about developments.

Conformity marking and identification number
(MedDO Art. 13 - Conformity marking and identification number)Devices placed on the market in Switzerland or made available on the Swiss market must bear a conformity marking in accordance with Annex 5. The conformity marking presented in Annex V to EU-MDR18 is also a permissible conformity marking.In addition to the CE mark described in Annex V of the EU MDR, Annex 5 of the MedDO also describes a national conformity mark. Both markings are permissible.
 

Product information
(MedDO Art. 16 - Product information)Product information must be written in all three official languages of Switzerland. Article 16 regulates in which cases the product information may be written in less than the three official languages or in English (paragraph 3).

Information on implantable devices
(MedDO Art. 20 - Information on implantable devices)For implantable products, the manufacturer must provide, in addition to the product information required under Article 16, the information required under Article 18 paragraph 1 EU-MDR33, including the implantation certificate. The implantation certificate must be written in all three official languages of Switzerland.

Registration of Economic Operators                                                                                                                                         (MedDO Art. 55 -Registration of Economic Operators)Manufacturers or their authorised representatives and importers must register the information required by part A of Annex VI to EU-MDR69 with Swissmedic within three months of placing a device on the market for the first time.Application form: Unique identification number according to Art- 55 MedDO (CHRN Swiss Single Registration Number).

Medical Devices Information System
(MedDO Section 2 - Medical Devices Information System)Articles 83 - 92 describe an information system for medical devices. Swissmedic is responsible for this information system and is responsible for drawing up regulations for its use. Data can be obtained from EUDAMED as well as from cantonal electronic systems.

Affixing the UDI                                                                                                                                                                                    The deadlines for affixing the UDI, do not deviate from the EU MDR and are regulated as follows (MedDO Art. 104 - Affixing the UDI):

• for implantable and class III devices: from 26 May 2021;
• for class IIa and IIb devices: from 31 December 2027;
• for class I devices: from 31 December 2028;
• for reusable devices where the UDI has to be affixed to the product itself: two years after the dates given in letters a–c for the relevant product class.

Appointment of authorised representatives(MedDO Art. 104a - Appointment of authorised representatives)If the manufacturer is domiciled in an EU or EEA state, or if the manufacturer has designated an authorised representative domiciled in an EU or EEA state, that manufacturer must designate an authorised representative in accordance with Article 51 paragraph 1 within the following time periods:

• for class III devices, class IIb implantable devices and active implantable devices: by 31 December 2021;
• for non-implantable class IIb devices and class IIa devices: by 31 March 2022;
• for class I devices: by 31 July 2022.

• SwissMedic
• MDR / IVDR 
• MepV
• Website of the European Commission for Medical Devices
• IMDRF Documents
• IMDRF UDI
• EUDAMED
• EUDAMED Timelines
• MedTech Europe – Basic UDI-DI
• Management of Legacy Devices MDR EUDAMED
• GS1 UDI Guide
• Are you ready for UDI
• Be ready for UDI in the EU

• FDA
• Notified Bodies
   
• Healthcare GTIN Allocation Rules > Decision-Support Tool

GS1 Healthcare Videos

• UDI und das GS1 System im Gesundheitswesen
• GS1 Switzerland Basis UDI-DI (in Deutsch)
• GS1 Switzerland Basic UDI-DI (in Englisch)
• GS1 Switzerland Basic UDI-DI (Untertitel in Französisch)
• GS1 Switzerland Basic UDI-DI (Untertitel in Italienisch)
• UDI Teil 1 - Definition und Ziele
• UDI Teil 2 - Elemente von UDI
• UDI Teil 3 - BUDI-DI, UDI-DI, UDI-PI
• UDI - Software as a medical device

• Podiumsgespräch MDR&UDI

Frequently asked questions : FAQ – Unique Device Identification (UDI), MDR & IVDR

Medical Device Coordination Group Document May 2022