Europe – Euro Roundup: Switzerland moves to mitigate split from EU on device regulation

Switzerland has adopted supplemental provisions to its new Medical Devices Ordinance (MedDO) to soften the impact of its split from the European Union. The action comes as the failure to update a mutual recognition agreement (MRA) erects barriers to trade between Switzerland and the EU.

Swiss medical device manufacturers have enjoyed barrier-free access to the EU single market since 2001. However, the EU refused to consider updating the MRA in light of the new EU Medical Device Regulation until there is a deal on a proposed Institutional Framework Agreement with Switzerland. The failure to reach an agreement on the framework means the MRA remains unchanged.

Switzerland responded to the loss of barrier-free access to the single market and resources such as the EUDAMED database by amending MedDO. The amendment unilaterally allows devices certified in the EU to continue entering Switzerland to avoid supply disruptions. Switzerland has also added requirements for the registration of economic operators, the reporting of serious incidents and the establishment of authorized representatives for manufacturers based outside the country…