FGK Representative Service Ireland Ltd

FGK Representative Service Ireland Ltd. provides sponsor representation for companies without subsidiary within the European Union planning to conduct clinical investigations with medical devices in this region.

On 26 May 2021, Regulation (EU) 2017/745, the Medical Device Regulation (MDR), has become applicable for clinical investigations with medical devices. EU member states needed to decide whether pursuant to Article 62. 2 (1) of MDR a legal representative of non-EU sponsors should be appointed or pursuant to Art 62. 2 (2) MDR a contact person in the EU will be sufficient. FGK Representative Service Ireland Ltd. may provide both services.

On 26 May 2022, Regulation (EU) 2017/746, the In-Vitro-Diagnostic Medical Device Regulation (IVDR), has become applicable for performance of studies with medical devices. EU member states needed to decide whether pursuant to Article 58 (4) of IVDR a legal representative of non-EU sponsors should be appointed or whether a contact person in the EU will be sufficient. FGK Representative Service Ireland Ltd. may provide both services. 

FGK Representative Service Ireland Ltd.,
Ellerman House,
Cratloe Wood, Cratloe, Co. Clare V95X925,
Ireland

Phone: +353 65 6711205
Fax:  +353 65 6711206
Email: info@fgk-rs.com