MDStudy object

MD - Definition available in national law

Yes

MD - Definition

Definitions for different types of Medical Devices are provided in Secton 2 & 3 of Act No 268/2014 Coll. on Medical Devices
e.g '(2) Medical device intended for clinical investigation shall mean any device intended for use by a duly qualified medical practitioner exclusively for the conduct of its own efficacy and safety in the course of a clinical investigation in adequate human clinical environment.'

Investigation of MD - Definition available in national law

Yes

Investigation of MD - Definition

Clinical investigation (pursuant to Section 11(4) of Act No 268/2014 Coll. on Medical Devices):
'the use of the medical device in a trial subject in the process of systematic testing at the premises of a provider of healthcare services with the objective to
a) evidence whether the tested medical device is suitable for use in compliance with the intended purpose, particularly in respect of safety and efficacy;
b) establish the influence of the medical device upon the trial subject; and
c) specify the side effects of the tested medical device and evaluate whether they represent acceptable risks.'

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