Lithuania Regulatory Requirements

The regulatory requirements for medical devices in Lithuania are based on the EU Medical Devices Regulation 2017/745 (MDR) and the EU In Vitro Devices Regulation 2017/746 (IVDR), which will fully apply from May 2021 and May 2022 respectively. Medical devices are classified according to risk into Classes I, IIa, IIb and III, and in vitro diagnostic devices are classified into four categories: A, B, C and D. Manufacturers of medical devices must obtain CE marking for their products, except for custom-made devices, those intended for use in clinical investigations and IVDs intended for use in clinical assessments. Manufacturers of class IIa, IIb and III medical devices and custom-made active implantable medical devices have to notify the Lithuanian State Health Care Accreditation Agency (VASPVT) when these devices are placed on the market in Lithuania. Alternatively, their authorized representatives or their authorized distributors have to notify the VASPVT. Non-European manufacturers must appoint a European Authorized Representative to access the Lithuanian market. The registration process takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device.