June 2021: Slovakia Regulatory Update

Clinical Trials With Medical Devices: Questions About the EUDAMED Database and Regulation EP and R (EU) 2017/745 (MDR)

The State Institute for Drug Control (SUKL), regulatory agency of Slovakia, has posted an update addressing the questions related to registration in the EUDAMED database and the Regulations on Medical Devices [Regulation (EU) 2017/745]. The update provides information on the following: registration obligations for EUDAMED, Declaration of Responsibility for Information Security, notification of different classes of medical device (ZP) to SUKL, validity of certificates issued before 26 May 2021.

Additionally, the update also covers information regarding the devices lawfully placed on the market before 26 May 2021 and the timeline for the Unique Device Identification (UDI) carrier to be placed on the device. For further details please follow the link.

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