Since 2002, a Mutual Recognition Agreement (MRA) has linked the European Union and Switzerland to facilitate their bilateral exchanges: Directive 93/42/EEC and Directive 90/385/EEC on medical devices (MD) and active implantable medical devices (AIMD) were covered by this MRA. Due to the general political context (withdrawal of the negotiations on the institutional framework agreement between Switzerland and the EU), the European Commission did not pursue the updating of the MRA which was required from 26 May 2021, date of application of Regulation (EU) 2017/745.

But then what are the consequences of this “Swixit” on the regulatory landscape of medical devices? And how can we continue to market medical devices in this context?

nexialist takes stock , from both perspectives! 

What are the consequences of this non-renewal of MRAs for European manufacturers wishing to place their devices on the Swiss market? 

In order to ensure the supply of safe and effective medical devices to Switzerland, the Swiss Federal Council has taken several mitigating measures in 2021.
Firstly, the Swiss regulation on MDs has been amended to take into account Regulation (EU) 2017/745. The revised Ordinance on Medical Devices (ODim) became effective on 26th May 2021.

Secondly, Switzerland unilaterally recognises certificates of conformity issued by EU notified bodies. The good news is that certificates of conformity with Directive 93/42/EEC or Directive 90/385/EEC are also recognised. Indeed, legacy devices benefit from transitional arrangements under the same conditions and deadlines as those specified in Article 120 of the EU Regulation. This means that devices with a certificate of conformity to the Directive may continue to be made available on the Swiss market until the certificate expires, but no later than 26 May 2024.

There is no need to switch to a Swiss notified body… However, several actions must be taken by European manufacturers to continue marketing their devices in Switzerland:

Appointment of a Swiss authorised representative (CH-REP)

The European manufacturer must establish a mandate with an authorised representative based in Switzerland.
The Swiss authorised representative will be in charge of the marketing formalities with the Swiss competent authority (Swissmedic), and in charge of activities related to the safety of the MDs. Its rights and obligations are specified in Articles 51 and 52 of the ODIM, which themselves refer to the corresponding Articles 11 and 12 of Regulation (EU) 2017/745. He will have to register his activity with Swissmedic in order to obtain a CHRN (Swiss registration number).

Designation of an importer

Inevitably, the economic operator who places a device on the Swiss market for the first time becomes an “importer” and must comply with his obligations under the ODIM (Articles 53 and 55 which refers to Articles 13, 16, 30 and 31 of the MDR). Like the authorised representative and the manufacturer, he is obliged to register his activity with Swissmedic in order to obtain the CHRN.

Updates on labelling

Newly involved economic operators means impact on the labelling or on the documents accompanying the device. The way in which the Swiss authorised representative and the importer are indicated on the labelling depends on the regulation applied:

• For devices compliant with Regulation (EU) 2017/745:
  • The Swiss authorised representative must be indicated on the label. However, for Class I devices, there is a transitional period until 31 July 2023 for the indication of the Swiss authorised representative on the label. Until that date, the indication of the authorised representative on a document accompanying the device (such as the delivery form) is also accepted.
  • The importer must be indicated on the device or on its packaging or on a document accompanying the device.
• For devices complying with Directive 93/42/EEC :
  • The Swiss authorised representative must be indicated on the label or in the instructions for use user manual or on a document accompanying the device.
  • The importer must be indicated on the device or on its packaging or on a document accompanying the device.
• For devices complying with Directive 90/385/EEC :
  • The Swiss authorised representative must be indicated on the commercial packaging and in the instructions for use user manual.

The importer must be indicated on the device or on its packaging or on a document accompanying the device.

Registration of devices and economic operators

The non-renewal of the mutual recognition agreement no longer allows economic operators to carry out the various registrations on the European database Eudamed. Swissmedic has therefore developed its own database called Swissdamed, for Swiss Database on Medical Devices, original isn’t it?

Regarding the technical characteristics of the platform, little information has been given for the moment but we already know that it will be composed of two interconnected modules relating to MD and economic operators. A free access web page will also be available. Moreover, due to the similarity between the European and Swiss requirements, the information to be filled in should be equivalent to that of the corresponding modules of Eudamed.

It should be noted that economic operators who have already registered with Swissmedic and who have therefore obtained a unique Swiss registration number (CHRN) will not need to register in Swissdamed.

The implementation of the registration requirement in Swissdamed is not foreseen for the time being! Indeed, it is only after an amendment of the ODim that the registrations in Swissdamed will become mandatory, the operational launch being planned for 2023.

For more information, see the Swissmedic fact sheet.

What are the consequences of this non-renewal of MRAs for Swiss manufacturers who wish to place their devices on the EU market? 

The EU will no longer recognise certificates issued by Swiss Notified Bodies, including those issued before 26th May 2021 (issued under the MRA). This means that devices with such a certificate must be certified by an EU Notified Body in order to continue to be marketed in the EU.
Furthermore, as Switzerland is now considered a “third country”, Swiss manufacturers must appoint a European authorised representative in order to import their device.
If the devices are covered by certificates issued by notified bodies established in the EU under the MRA, these remain valid provided that an authorised representative established in the EU is appointed.
In the same way as in the reverse situation, the economic operator placing a device on the European market for the first time becomes an “importer” and must comply with its obligations under Regulation (EU) 2017/745.
In terms of impact on labelling:

• • The name and address of the importer must appear on the device, the packaging or in a document accompanying the device
  • The name and address of the authorised representative must appear on the label

The registration of the devices and the economic operators (Swiss manufacturer, European authorised representative and importer) must be carried out in the Eudamed database.

Does the non-renewal of the MRA have an impact in other types of situations?

Manufacturers located in other non-EU countries (e.g. Canada or the US) who previously had a European authorised representative present in Switzerland will have to appoint another authorised representative located in the EU.

In conclusion

The non-renewal of the MRA with the EU is not an obstacle to the free movement of medical devices between Switzerland and the EU, but requires a certain number of adaptations for economic operators. The new Swiss regulation, with its multiple references to the MDR and its transitional provisions, limits the effects of this “Swixit” and greatly facilitates the change.

If you would like to know more about this subject, do not hesitate to reach us via our networks or our contact form on our website.