The Medical Devices Regulation (MDR) date of application is looming: 26 May 2021. And yet, still no update has been made to the mutual recognition agreement between Switzerland and the EU to include the MDR.

What does this mean for access to the Swiss market? And to Swiss manufacturers’ continued access to the EU market? Are we facing a ‘Swixit’ / ‘Swexit’ for medical devices?

Background

Switzerland is not, and never has been, a member of the European Union. Nor is Switzerland a member of the European Economic Area (EEA), which is made up of the EU and following other non-EU countries: Iceland, Liechtenstein and Norway. Switzerland voted against joining the EEA by less than 1% in 1992.

Instead, Mutual Recognition Agreements (MRA) were put into place between Switzerland and the EEA, allowing mutual access to one another’s’ markets. Some of the initial agreements were originally drafted in the 1990s and include recognition of the Medical Devices Directive 93/42/EEC, In Vitro Diagnostics Devices Directive 98/79/EC and the Active Implantable Medical Devices Directive 90/385/EEC.

Since 2014, Switzerland and the EU Commission have been negotiating the Institutional Framework Agreement (‘InstA’) – an agreement intended to supplement and upgrade the existing MRAs. Due to the upcoming MDR date of application, there is discussion about amending the Medical Devices chapter of MRAs to ensure mutual recognition of the MDR between the two markets, while InstA undergoes continued discussion. However, the EU Commission has clearly stated that they are not interested in updating any of the MRAs without InstA also in place.

What’s the impact?

What will happen on 26 May 2021 if there’s no update to the MRA? Will CE marked medical devices no longer be allowed to be placed onto the Swiss market, leaving a tremendous gap in patient care? Will Swiss manufacturers no longer have access to the EU market, if they have a Swiss Notified Body? What about any manufacturer with CE marking through a Swiss Notified Body – will their CE Marking certificates be valid on 26 May 2021?

If an amended or new MRA is not put into place, then Switzerland could become a Third Country, like the UK. If so, the following is possible:

• Manufacturers with a Swiss Notified Body issued CE Certificate may have a problem, as it may not be recognized as valid conformity assessment for devices placed onto the EU
• Any manufacturer with a Swiss-based Authorized Representative (AR) may have a problem, as that entity may not be recognized a valid EU AR for devices placed onto the EU
• Swiss manufacturers may need to obtain an EU-based AR to continue placing devices onto the EU
• Will non-Swiss manufacturers need to obtain a Swiss Authorized Representative?
• Will Switzerland continue to accept CE Marking certificates issued by an EU Notified Body, or will they require a Swiss-issued conformity assessment certificate?

These are all currently unknowns. Fingers crossed that this is resolved in the coming months, to prevent further confusion and disruption to the medical devices market in Europe.