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.
For systems and procedure packs, an authorised representative in accordance with Article 51 paragraph 5 must be appointed by 31 July 2022.
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.