Switzerland may not sign the Institutional Framework Agreement (InstA) with the EU prior to the 26 May 2021 deadline. In such an event, medical devices manufacturers operating 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 provides EU Authorized Representative services from our office in Vienna, Austria. Since its founding in 2009, SFL has been at the forefront of the regulatory developments in Switzerland and the EU and has been an active member of several trade associations. SFL’s long-term experience in representing industry interests and interacting with stakeholders makes SFL a reliable and knowledgeable partner acting as your EU Authorized Representative.

SFL’s cross-functional team provides full support to medical device and in vitro diagnostics manufacturers including assessment of classification, creation and maintenance of QMS, ISO 13485 certification, audits, risk management, clinical evaluation and technical documentation, general safety and performance requirements conformity, post-marketing support as well as supply chain solutions.

Please do not hesitate to contact SFL to arrange a call. SFL’s seasoned professionals are looking forward to answering your questions.