Both the EU Commission and Swiss Federal Council released statements that they could not come to terms regarding an amendment to the Medical Devices chapter of the Mutual Recognition Agreement, to cover the requirements around the Medical Device Regulation (MDR). This means that Switzerland is now a third country as it relates to medical devices.

How we got here:

• Mutual Recognition Agreements (MRAs) put into place between Switzerland and the EU over the years, covering a variety of industries.
  • Medical devices are covered in Chapter 4 of Bilateral Agreements I.
  • Specifically covered are the Medical Devices Directive (MDD) 93/42/EEC, Active Implantable Medical Devices (AIMD) 90/385/EEC and In Vitro Diagnostic Devices (IVDD) 98/79/EC.
• Since 2014, Switzerland and the EU have been negotiating a new Institutional Framework Agreement (‘InstA’ or ‘IFA’).
  • The EU Commission stated several times that they will not put into place new MRAs, or amend existing MRAs, without InstA.
• Switzerland implemented the EU MDR into its medical device regulation – the Medical Devices Ordinance (“MedDO”).
• As of 26 May 2021, Switzerland becomes a third country as it relates to medical devices:
  • On 26 May 2021 the Swiss Federal Council announces that Switzerland will not sign Institutional Framework Agreement and that “this brings the negotiations on the draft of the InstA to a close”.
    • Among the reasons cited for rejection are wage protection and state aid issues.
    • The same day, the EU Commission releases its own statement confirming that “until a potential agreement on the proposed modification to the MRA is reached, the trade facilitating effects of the MRA for medical devices falling under the new Medical Devices Regulation, including the mutual recognition of conformity assessment results, the absence of the need for an authorised representative and the alignment of technical regulations, cease to apply as from today Wednesday 26 May 2021.”
• The Swiss Federal Council publishes amendments to the MedDO to mitigate the negative effects, including update to the articles related to notified bodies, authorized representatives and importers.

What is the impact on non-Swiss device manufacturers?

• Manufacturers must appoint a Swiss Authorized Representative (CH-REP) and notify the Swiss Competent Authority (Swissmedic) of the appointment. However, a transition period is granted:
  • 31 December 2021: AIMD/Class III/Class IIb implantable devices
  • 31 March 2022: Class IIb non-implantable/Class IIa devices
  • 31 July 2022: Class I devices/Systems and Procedure Packs
• Manufacturers must place the CH-REP information on their labeling by the above deadlines.
• Manufacturers who had a Swiss-based EU Authorised Representative must now appoint an EU-based Authorised Representative.
• A Swiss Importer is now required.
• Swissmedic will continue to recognize CE Marking certificates issued by either a Swiss-based Notified Body or an EU-based Notified Body. However, if your Notified Body is Swiss-based, that Notified Body issued CE Marking certificate is no longer recognized in Europe. Manufacturers must instead obtain CE marking certificates from an EU-based Notified Body. Click here to see Swissmedic’s current list of designated (aka notified) bodies.
• Devices must be registered per Swissmedic’s current requirements. Since Switzerland no longer has competent authority level access to EUDAMED, registration requirements may change over time.

What is the impact on Swiss device manufacturers?

• The EU will no longer recognize CE Marking Certificates issued by a Swiss-based Notified Body as valid.
  Swiss manufacturers must appoint a European Authorized Representative.
• Swiss manufacturers must now comply with registration both with the Swiss Competent Authority and EU registration requirements related to devices and economic operators.
• An EU importer is now required.

This shakes up the European market even further. We will keep you apprised as changes develop.