Performance studies
Information on submission of applications and notifications pursuant 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 May 26, 2022, Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and on the repeal of Council Directive 98/79/EC and Commission Decision 2010/227/EU (hereinafter referred to as "IVDR") has come into effect.
Subsequently, on December 22, 2022, Act No. 375/2022 Coll., on medical devices and in vitro diagnostic medical devices, entered into force.
In continuation with the above-mentioned legislation, sponsors of certain types of performance studies (hereinafter also referred to as "PS") are obliged to submit an application for authorisation to conduct a PS to the State Institute for Drug Control (hereinafter referred to as „SÚKL“), or to send a notification of the PS to SÚKL, respectively.
In practice, how does the sponsor find out whether the PS, which they intend to conduct, is subject to the obligation to submit an application for or to the obligation to send a notification of the conduct of such PS to SÚKL?
PSs can be divided into groups according to the characteristics listed below (see below the description of groups 1-8), for which it is further stated in the text whether it is necessary to apply for authorisation or to send a notification to SÚKL.
- PS is/is not conducted to demonstrate conformity with IVDR requirements.
- PS is conducted with an in vitro diagnostic medical device (hereinafter referred to as “IVD”) that is/is not a companion diagnostic to the medicinal product.
- Only left-over samples are used/are not used in PS.
- Sample-taking in PS is/is not invasive.
- PS is/is not interventional.
- Within the PS, subjects are/are not exposed to other risks resulting from their participation in the study.
- PS is/is not conducted with a medical device bearing the CE marking and this device is used in accordance with its intended purpose.
- PS is conducted with an IVD bearing the CE marking, this device is used in accordance with its intended purpose and at the same time other burdensome procedures are/are not applied.
A simple decision-making algorithm can also be used to determine regulatory pathway for the submission of a PS. See Annex 1.
PS group 1
PS pursuant to Article 58(1) of the IVDR provisions aiming to demonstrate conformity with the requirements of the IVDR that use samples which are not only left-over samples and/or falls into one or more of the following categories:
a) PS in which surgically invasive sample-taking is done only for the purpose of the performance study
b) PS that is an interventional clinical performance study as defined in point (46) of Article 2,
c) PS, the conduct of which involves additional invasive procedures or other risks for the subjects of the study.
Requires an application. You can find an overview of the procedure here.
PS group 2
PS pursuant to Article 58, paragraph 2, first sentence of the IVDR (companion diagnostics) provisions, aiming to prove conformity with the requirements of the IVDR and falling into one or more of the following categories:
a) PS in which surgically invasive sample-taking is done only for the purpose of the performance study
b) PS that is an interventional clinical performance study as defined in point (46) of Article 2
c) PS, the conduct of which involves additional invasive procedures or other risks for the subjects of the study.
Requires an application. You can find the overview of the procedure here.
PS group 3
PS pursuant to Article 58, paragraph 2, second sentence of the IVDR (companion diagnostics using only left-over samples) provisions, aiming to demonstrate conformity with the requirements of the IVDR.
Requires simplified notification. You can find the overview of the procedure here.
PS group 4
PS pursuant to provisions of Article 70, paragraph 2 of the IVDR, aiming to assess a device bearing the CE marking in accordance with Article 18, paragraph 1 of the IVDR, outside the scope of its intended purpose.
Depending on the combination of other criteria listed below, the procedure for group 1, 2, 3 or 7 will be used. Specific combinations of criteria are given in the description of the mentioned PSgroups.
Other criteria for determining the correct procedure:
1) it is/is not a companion diagnostic,
2) samples are/are not left-over samples,
and/or
3) fall/do not fall into one or more of the following categories:
- surgically invasive sample-taking is done only for the purpose of the PS,
- a study that is an interventional clinical PS
- a study, where the conduct of the study involves additional invasive procedures or other risks for the subjects of the studies.
PS group 5
PS pursuant to provisions of Article 70, paragraph 1 of the IVDR, aiming to assess a device bearing already the CE marking in accordance with Article 18, paragraph 1 of the IVDR (hereinafter referred to as "PMPF study“) within the scope of its intended purpose, provided this PS involves exposing subjects to other procedures, than those conducted under normal conditions of use of the device, and these additional procedures are invasive or burdensome.
Requires notification. You can find the overview of the procedure here.
PS group 6
PS with a CE-marked IVD device (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 such additional procedures are not invasive or burdensome. Pursuant to Article 70 paragraph 1 of the IVDR, the obligation to submit a permit application or notification does not apply to such a PS.
No application or notification required.
PS group 7
PS with an IVD that is not a companion diagnostic and at the same time does not fall into any of the following categories:
a) PS in which surgically invasive sample-taking is only done for the purpose of the performance study
b) PS that is an interventional clinical performance study as defined in point (46) of Article 2
c) PS, the conduct of which involves additional invasive procedures or other risks to the subjects of the studies.
No application or notification required.
PS group 8
PS with an IVD (bearing or not bearing the CE marking) that is intended solely for systematic scientific research purposes, not carried out to demonstrate conformity with the requirements of IVDR. A typical example would be the use of an IVD to specify the tumour characteristics that are to be used for reverse stratification of response to anticancer treatment (whereas it is true that the aim of this research is not to demonstrate conformity with the IVDR).
No application or notification required.
Information on serious adverse events (SAE) during performance studies pursuant to IVDR requirements.
For reporting, use the SAE reporting form for medical devices, in line with MDCG 2020-10/2 Clinical Investigation Summary Safety Report Form v1.0, as follows here .
Reporting can be done via RZPRO (https://eregpublicsecure.ksrzis.cz/Registr/RZPRO) or via email khzp@sukl.cz, in Czech or English.
Department of Clinical Evaluation of Medical Devices