The medical devices legislation of the Federal Office of Public Health specifies which decisions of the EU Commission are applicable in Switzerland and when. In recent years, the EU has tightened the requirements for medical devices in order to improve the quality and safety of these products. The EU regulations on medical devices (MDR) and in vitro diagnostic medical devices (IVDR) came into force on 26 May 2017 and have been fully applicable since 26 May 2021 and 26 May 2022 respectively.
Switzerland has adapted its legislation in the same way in order to harmonise it with that of the EU. The provisions of the MDR have been incorporated into the TPA, the HRA, the MedDO and the new ClinO-Mep. The ordinances have been in force since 26 May 2021. The provisions of the IVDR were transposed into the TPA, the HRA, the new IvDO and the ClinO-Mep, which have been in force since 26 May 2022.
The agreement between the Swiss Confederation and the European Union on the mutual recognition of declarations of conformity (MRA) has stalled due to a lack of progress on institutional issues between Switzerland and the EU. The European Commission has so far refused to update this chapter. The Federal Office of Public Health provides ongoing information on the effects and the current status of development on its FOPH medical devices webpage.

UDI carrier on the labelling
A UDI carrier is affixed to the labelling of your products and to all higher packaging levels (with the exception of shipping containers) depending on the classification of the product in risk classes. 

MD classes (see MDR Art. 123 para. 3f)

IVD classes (see IVDR Art. 113 para. 3e)

The deadlines for the introduction (arrows) of the risk classes are announced in the Swissmedic regulations. Please note that other deadlines apply for reusable devices for which the UDI carrier must be applied directly to the device. 

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 26 May 2023;
• for class I devices: from 26 May 2025;
• 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.

We recommend three procedures for implementing the UDI so that you fulfil the requirements of the MDR/IVDR:

1. Self-study
   Our clearly organised website shows you how to implement the UDI in 5 steps. You will also find many helpful tutorials and further links that will be useful to you on the path to implementation. All you need is a membership with a number range to label your products. 
2. Training and implementation
   You attend one of our many UDI training courses to build up the knowledge you need. The knowledge we impart and the useful information on our website www.gs1.ch/udi will help you to implement the UDI.
3. Targeted training for your company
   You don't have time to build up a UDI knowledge base and want to entrust us with this initial task? We help you to acquire targeted UDI knowledge by means of digital or on-site training courses. You choose the topics and the amount of time, we deliver the rest. Our UDI team will support you with the implementation. Get in touch with us and let us calculate your customised offer.