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Clinical Investigations with medical devices

For Clinical Investigations with medical devices in the EU please contact FGK-RS Ireland Ltd.

Article 62 (2) of the Regulation (EU) 2017/745, the Medical Device Regulation requires that an EU legal representative of non-EU sponsors should be appointed. FGK Representative Service Ireland Ltd. may provide this service.

For Clinical Investigations with medical devices in Switzerland please contact FGK-RS AG.

The Swiss Ordinance on Clinical Trials with Medical Devices requires for Sponsors without subsidiary or establishment in Switzerland to assign a representative in Switzerland. FGK Representative Service AG can provide this service.