In February 2021, FGK Representative Service Ireland Limited has been established to provide legal representation services for sponsor companies without subsidiary within the European Union planning to conduct clinical investigations with medical devices in this region. This is the 5th FGK Legal Representative company, which completes the network of FGK companies to cover all areas of legal representation in Europe, for studies with medicinal products and medical devices.
On 26 May 2021, Regulation (EU) 2017/745, the Medical Device Regulation (MDR), will become applicable for new clinical investigations with medical devices. Article 62 of MDR calls for: “Where the sponsor of a clinical investigation is not established in the European Union, that sponsor shall ensure that a natural or legal person is established in the European Union as its legal representative. Such legal representative shall be responsible for ensuring compliance with the sponsor's obligations pursuant to the MDR, and shall be the addressee for all communications of the EU member states.”
FGK Representative Service Ireland Ltd. starts with a group of regulatory experts with more than 15 years of experience, who provide competent, quick, and cost-efficient representation services of clinical investigations with medical devices in the European Union.
Martin Krauss, one of the three Directors of FGK Representative Service Ireland Ltd. is happy to announce the news: "We have been looking for a suitable location for a new FGK Representative Service subsidiary and are sure the subsidiary in Ireland is an excellent addition to expand our sponsor representation in the EU as we can meet the requirements of the MDR.”
If you are a company located outside the European Economic Area and in need for a legal representative for your clinical investigation in the European Union to ensure business continuity from 26 May 2021 on, just contact us and ask for an offer.
The new registered office of the company is located here:
Directors: Mark Turner, Martin Krauss, and Dr. Edgar Fenzl