Without an updated MRA having been produced by last year’s MDR deadline (26 May 2021), Switzerland became a third country for the purposes of MDR implementation. Almost one year on, our Head of Regulatory Corinne Larke brings us up to date with the latest developments regarding the ongoing EU-Swiss MRA situation.

The Mutual Recognition Agreement (MRA) is one of the key agreements between the EU and Switzerland, facilitating bilateral trade in key sectors such as machinery, motor vehicles and medical devices.

Since 1 June 2002 and before 26 May 2021, Switzerland participated in the European Union internal medical devices market through a specific chapter of the EU-Switzerland MRA, which previously recognised conformity assessment certificates between the EU and Switzerland based on equivalent regulations. The agreement facilitated seamless trade of medical devices between the two parties.

During the MRA negotiations leading up to the MDR deadline (26 May 2021), the EU made it clear that without an agreement with Switzerland on the institutional framework agreement, there could be no update of the MRA, including the chapter on medical devices. 

When negotiations failed, the EU declared that the previous mutual recognition procedures were no longer valid, making Switzerland a third country to the EU.

The notice to stakeholders on 26 May 2021 from the European Commission announcing the absence of an agreement regarding the proposed modification of the MRA laid out a new reality:

• Conformity assessments by Swiss Notified Bodies would no longer be recognised for devices entering the EU
• Certificates issued by Swiss Notified Bodies would no longer be recognised as valid in the EU
• Manufacturers located in Switzerland would need to designate an Authorised Representative established in the EU to allow them to export their products to the EU
• Manufacturers located outside of Switzerland would need to designate a Swiss Representative, and must register with Swissmedic to obtain a Unique Identification Number (“Swiss Single Registration Number” CHRN) to be able to import their products into Switzerland

Furthermore, with Switzerland regarded a third country, Swiss authorities would cease to have access to EUDAMED, and they would no longer be part of the working groups on joint surveillance of new medical devices.

Our article in June 2021 outlined the effect that the lack of an MRA update between Switzerland the EU was set to have on medical devices trade. Almost a year later, let’s take a look at what’s happened since.

August 2021 | SQS plans to cross the border

In response to Swiss Notified Body certificates for medical devices no longer being accepted by the EU, on 3 August 2021 Switzerland’s only Notified Body, SQS, announced its decision to open a subsidiary in Constance, Germany, from September 2021.

December 2021 | Swiss manufacturers with SQS certificates file complaint

On 8 December 2021, several Swiss manufacturers with SQS certificates filed a complaint with the General Court of the European Union, arguing that the EU Commission’s decision to terminate application of the MRA and the withdrawal of the MRA for Swiss legacy devices were contrary to EU law, the MRA itself, as well as World Trade Organisation (WTO) law.

The manufacturers requested:

• That legacy devices from Switzerland be allowed on the EU market under the same conditions as all other legacy devices, and
• That the EU and its Member States continue to allow sales of all medical devices with a valid MDD certificate issued by a Swiss Notified Body prior to 26 May 2021

January 2022 | German AGMP issues response

As a result of this action, on 20 January 2022, the German AGMP (Working Group on Medical Devices of the Supreme State Health Authorities) announced that certificates issued by Swiss Notified Bodies under Directives 90/385/EEC and 93/42/EEC would continue to be considered valid until the deadlines set out in Article 120(2) of the EU MDR.

This would allow Swiss manufacturers holding SQS certificates from the Swiss Notified Body to continue selling their MDD compliant medical devices in Germany, provided they have appointed an Authorised Representative located in the EU for those devices.

However, the EU promptly declared this decision by the German authorities as non-binding, leaving the legal situation for Swiss manufacturers unclear.

In a statement, the EU Commission announced that the interpretation by the German authorities was not in line with the clear Commission position. The Commission reiterated that as the MRA had not been updated, medical devices from Switzerland would only be allowed to be placed on the EU market if they held a certificate from a Notified Body located in the European Union.

February 2022 | Swiss Federal Council announces plans

In the months since the failed negotiations, the EU has been waiting for Switzerland to propose a new strategy. And in February this year, the Swiss Federal Council finally communicated their planned action.

The Council announced that it intends to continue pursuing the bilateral path, despite having no interest in discussing an updated framework agreement with the EU. The Federal Council plans to engage in sector specific agreements, especially in education, healthcare, and electricity.

The Swiss Government intends to offer continued cohesion payments and contributions to migration in exchange for sector specific agreements.

April 2022 | Current state of play  

It is still uncertain how the Federal Council’s approach will be received in Brussels, given previous signals from the EU that sector specific agreements are off the table. So as the EU-Swiss MRA topic remains an evolving situation, we will continue to monitor the state of affairs and keep you informed of any progress.

In the meantime, should you have any questions regarding this area please do get in touch – our Regulatory team is ready and happy to help.