EU/EEA Market Access for “Swiss Legacy Devices” following entry into application of the MDR

For Swiss manufacturers and manufacturers who relied on Swiss authorised representatives or notified bodies the entry into force of the MDR has raised a number of particularly difficult legal questions, due to the fact that the Mutual Recognition Agreement between the EU and Switzerland was not updated to fully encompass the changes brought about by the MDR. This memorandum by Sidley Austin explores the key legal challenges these companies face in accessing the EU market and provides a valuable interpretation of the legal framework within which these companies now find themselves.