Switzerland plans new pathway for non-EU medical devices
Switzerland is preparing to introduce a more flexible regulatory framework to strengthen the supply of medical devices in its market. The Federal Council intends to establish a legal basis for granting market access, under justified conditions, to devices that do not bear CE marking but comply with internationally recognized regulatory systems.
A shift in Swiss regulatory strategy
This move reflects a strategic effort to reduce dependency on the European Union’s regulatory framework, especially following the absence of a fully functioning Mutual Recognition Agreement (MRA). By exploring alternative compliance routes, Switzerland aims to prevent supply shortages and maintain patient safety, even in the absence of EU-specific conformity.
The future framework would enable access to non-CE-marked medical devices in limited and justified cases, based on compliance with global standards. While the criteria and systems to be recognized have not been officially detailed, the direction points toward increased regulatory flexibility for non-EU manufacturers. In parallel, the Federal Council also foresees the possibility of delegating conformity assessments to private, accredited bodies to ensure continued oversight of safety and performance.
Preparing for the evolving Swiss market
Manufacturers outside the EU may consider this development an opportunity to access the Swiss market through new pathways. To stay aligned with regulatory expectations, companies should monitor ongoing updates from the Swiss authorities, assess their current documentation against international benchmarks, and identify product lines that could potentially benefit from the upcoming provisions.
Strategically planning for this regulatory evolution will allow manufacturers to anticipate requirements, adapt internal processes, and approach market entry in Switzerland with greater confidence and readiness.
The role of the Swiss authorised representative (CH-REP)
Non-Swiss manufacturers placing medical devices on the Swiss market are required to appoint a Swiss authorised representative (CH-REP). This entity acts as the official point of contact with Swiss authorities and is responsible for ensuring compliance with national requirements on labelling, vigilance, and technical documentation availability.
This obligation remains valid regardless of the regulatory framework under which the device is approved and continues to apply in the context of the planned legal changes.
