Czech Republic: Amendment of the Act on Medical Devices

28 July 2010

Vojtech Chloupek

New legislation on medical devices entered into force in the Czech Republic on 16 June 2010. The amendment partially implements the EU Directive 2007/47/EC of 5 September 2007 and relates to, in particular, conditions for the use of medical devices, clinical trials, prescription, release, purchase, warehousing and sale of medical devices, notification duties; state control and fines.

One of the most important changes consists in the new comprehensive specification of requirements for the conduct of clinical trials. The amendment also shifts the responsibility for the supervision of clinical trials and notifications of new devices on the market from the Czech Ministry of Health to the State Institute of Drug Control.



Vojtech Chloupek

Czech Republic & Slovakia

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