The harmonization of medical devices under EU MDR means that medical devices are now subject to one single set of

regulatory requirements. This means that a medical device type-examined in one Member State can be placed on the

market anywhere within the EU. An organization in the Czech Republic which checks compliance with the safety of medical devices in accordance with the requirements of EU laws is State Institute for Drug Control.

The mission of the SÚKL is to ensure, for public health protection purposes, that only those pharmaceuticals which are of

good pharmaceutical quality, efficacy, and safety, be applied in practice and during clinical trials, that quality and safe raw

materials be used in the manufacture and preparation of pharmaceuticals, and that safe and functional medical devices with information describing objectively established properties be used and that data from the research of pharmaceuticals, raw materials, and devices be credible and obtained in an ethical manner.