In February 2021, FGK Representative Service Ireland Ltd. has been opened to provide 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), will become applicable for new clinical investigations with medical devices. EU member states will need 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.
FGK Representative Service Ireland Ltd.,
Cratloe Wood, Cratloe, Co. Clare V95X925,
Phone: +353 65 6711205
Fax: +353 65 6711206