CASubmissionFormat object

Format option(s)

Electronically
Via the Registry of Medical Devices (RZPRO)

Online portal

http://www.sukl.eu/medical-devices/launch-of-the-new-registry-of-medical-devices-rzpro

Standard application form available

Yes

Standard application form

Standard Clinical Investigation Notification Forms for MD and AIMD (active implantable MD) are available on the SÚKL website in Czech and English: Medical Devices / Clinical evaluation of medical devices / Guidelines and Forms

Guidance on submission format

Related details are available on SUKL website in section: Medical Devices / Clinical evaluation of medical devices / Application for authorisation of clinical investigation conduct.
The required contents of clinical investigation dossier specified in Section 21 of Act No 268/2014 on Medical Devices

Applicable national legal framework/ Reference

Section 15 and 21 of Act No 268/2014 on Medical Devices

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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