Clinical Investigations - Medical Devices

Submission of applications for authorisation of CPs after the effective date of EU Regulation 2017/745

Pursuant to Article 70(1) of EU Regulation 2017/745, applications for clinical trial authorisation shall be submitted through the European Database for Medical Devices (“EUDAMED”). The launch date of the EUDAMED database is currently unknown.

Until the Clinical Investigations Module in EUDAMED is fully operational, the Register of Medical Devices (RZPRO) will be used for clinical trial applications/notifications under Article 62, Article 74(1) and (2) of EU Regulation 2017/745, requests for substantial changes to clinical investigations and reporting of serious adverse events arising during the aforementioned clinical investigations.

As of 7 March 2024, when the Information System for Medical Devices (ISZP) established pursuant to and Act 375/2022 Coll., on Medical Devices and In Vitro Diagnostic Medical Devices (hereinafter referred to as the “Device Act”) was launched, clinical investigations pursuant to Article 82 of EU Regulation 2017/745 shall be notified via the ISZP, as well as requests for substantial changes and reporting of serious adverse events arising in connection with such investigations.