Ensure uninterrupted access to the EU market.
If the Institutional Framework Agreement (InstA) between Switzerland and the EU is not signed and ratified by 26 May 2021, the Mutual Recognition Agreement between Switzerland and the EU will not be updated. In such an event, medical device manufacturers from Switzerland and with no legal manufacturing entity in the EU are required to designate an EU Authorized Representative to market their products in the EU after this date.
SFL now offers EU Authorized Representative services to non-EU-based medical device manufacturers. SFL’s cross-functional competence – integrating extensive Regulatory, Quality, Vigilance and Legal team expertise – together with our long-term presence in various EU countries, allows us to offer trustworthy and comprehensive services.
