June 2021: Slovakia Regulatory Update

Clinical Trials With Medical Devices: EP and R Regulation (EU) 2017/745 on ZP (MDR) – EUDAMED, UDI

The State Institute for Drug Control (SUKL), regulatory agency of Slovakia, published an update on 01 June 2021 that outlines the registration procedures related to EUDAMED. The update also details the ACTORS module and Unique Device Identification (UDI) process.

It covers the following points- role of the EUDAMED in data provision, various electronic systems within EUDAMED and their launch schedules, electronic system registration of economic operators under Article 30, and registration of manufacturers, authorized representatives, and importers under Article 31.

Additionally, it also incorporates the registration of economic operators and allocation of Germany under the ACTORS module, and information related to UDI- a standardized system for the identification of medical devices, along with the timetable for the introduction of UDI in the European Union (EU). Further information can be accessed through the link.

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