Drug database
Clinical Investigation / Performance Studies
Clinical Investigation
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.
Performance Studies
From the date of entry into force of EU Regulation 2017/745, performance study applications are submitted and assessed in accordance with Articles 70 and 74 and Annex XV, Chapter II of EU Regulation 217/745. Substantial changes to a clinical investigation are submitted and assessed according to Article 75 and Annex XV, Chapter II of EU Regulation 217/745. Serious adverse events occurring during the clinical investigation are reported in accordance with Article 80(2) of EU Regulation 2017/745.
TIP: Answers to frequently asked questions can be found in the Q&A section.
Information on the submission of requests and notifications in relation to Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Council Directive 98/79/EC and Commission Decision 2010/227/EU (IVDR) As of 26.05.2022, Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Council Directive 98/79/EC and Commission Decision 2010/227/EU (IVDR). As of 22 December 2022, Act No. 375/2022 Coll. on medical devices and in vitro diagnostic medical devices is in force.
In connection with the above mentioned legislation, the sponsors of certain types of performance studies (hereinafter referred to as “PS”) are obliged to submit an application for authorisation to the Institute or to send a notification to the Institute.
In practice, how does a sponsor determine whether the PS it intends to implement is subject to the obligation to apply for a permit or to send a notice of implementation to the Institute?
PSs can be divided into groups according to the characteristics listed below (see description of groups 1-8 below), for which the text indicates whether they are subject to the need to apply for a approval or to send a notification to the Institute.
- PS is/is not performed to demonstrate compliance with the IVDR requirements
- PS is performed with an IVD device that is/is not a companion diagnostic to a medicinal product
- Only residual samples are/are not used in the PS
- Sampling in the SFZ is/is not invasive
- PS is/is not interventional
- In the PS, the subject is/is not exposed to other risks arising from his/her participation in the PS
- The PS is/is not performed with a medical device that has a CE mark and the device is used in accordance with the intended purpose of the medical device
- The PS is performed with an IVD device that has a CE marking, this device is used in accordance with its intended purpose and other burdensome procedures are/are not used
For a quick orientation regarding the inclusion of a performance study and the need to submit an application/notification, a simple decision algorithm can also be used here.
Performance studies under Article 58(1) of the IVDR to demonstrate compliance with the requirements of the IVDR that use samples that are not residual and/or that fall into one or more of the following categories: a) Surgically invasive sampling is performed for the sole purpose of the functional capacity study b) The study is an interventional study of clinical function c) It is a study whose conduct involves additional invasive procedures or poses other risks to study subjects.
Requires an application for authorisation. The procedure can be found here.
Performance studies as referred to in Article 58(2), first sentence, of the IVDR (companion diagnostics), to demonstrate compliance with the requirements of the IVDR; which fall into one or more of the following categories: a) Surgically invasive sampling is performed for the sole purpose of the functional capacity study b) The study is an interventional study of clinical function c) The study involves additional invasive procedures or poses other risks to the study subjects.
Requires an application for authorisation. The procedure can be found here.
Performance study in accordance with Article 58(2), second sentence of the IVDR (companion diagnostics from residual samples), to demonstrate compliance with the requirements of the IVDR.
Notification required. The procedure can be found here.
Performance study according to Article 70(2) IVDR, the purpose of which is to assess, outside the scope of its intended purpose, a device on which the CE marking is already affixed in accordance with Article 18(1) IVDR. In this case, Articles 58 to 77 of the IVDR shall apply. This means that the same requirements apply as for the SFZ under Article 58(1) of the IVDR
Requires an application for authorisation. The procedure can be found here.
Performance study according to Article 70(1) of the IVDR, the purpose of which is to assess, within the scope of its intended purpose, a device on which the CE marking is already affixed in accordance with Article 18(1) of the IVDR (hereinafter referred to as “PMPF”) and where this SFZ involves the exposure of subjects to other procedures, than those carried out under the normal conditions of use of the device and these additional procedures are invasive or burdensome.
Requires notification. The procedure can be found here.
Performance study of an IVD device bearing the CE marking (PMPF study) used in accordance with its intended purpose, which does not involve exposing subjects to procedures other than those performed under normal conditions of use of the device, and these additional procedures are not invasive or burdensome. Such SFZ is not subject to the obligation to apply for authorisation or notification in accordance with Article 70(1) of the IVDR.
It does not require an application or notification.
Performance study of an IVD device that is not a companion diagnostic and does not fall into any of the following categories: a) Surgically invasive sampling is performed for the purpose of a functional capability study b) The study is an interventional study of clinical function c) The study involves additional invasive procedures or poses other risks to the study subjects.
It does not require an application or notification.
An IVD device (both CE marked and non-CE marked) which is used in systematic scientific research but this research is not conducted for the purpose of demonstrating compliance with the requirements of the IVDR. A typical example would be the use of an IVD device to diagnose the characteristics of a tumour to be used to retrospectively stratify the response to anticancer treatment (it being understood that the aim of this research is not to demonstrate compliance with the IVDR).
It does not require an application or notification.