Performance studies

Medical devices also include in vitro diagnostic medical devices for which Regulation (EU) 2017/746 on in vitro diagnostic medical devices (hereinafter IVDR) applies from May 26 2022 onwards.

For in vitro diagnostic medical devices, performance studies are undertaken to establish or confirm the analytical or clinical performance of a device. Provisions regarding clinical evidence, performance evaluation and performance studies are set out in Chapter VI of the IVDR (Article 56 to Article 77). Supporting documents adopted by the Medical Device Coordination Group (MDCG) are available on the website of the European Commission Guidance – MDCG endorsed documents and other guidance (europa.eu).

Performance studies are considered to be conducted in the Republic of Slovenia where either the study:
  • site is based in the Republic of Slovenia, or
  • participants/specimens originate from the Republic of Slovenia.
The requirements and different types of performance studies described in the IVDR:
  • General requirements regarding performance studies – Article 57 IVDR,
  • Additional requirements for certain performance studies – Article 58 IVDR,
  • Performance studies involving companion diagnostics using only left-over samples – Article 58(2) IVDR,
  • Performance studies regarding devices bearing the CE marking (PMPF study) – Article 70(1) IVDR,
  • performance studies outside the intended purpose of an in vitro diagnostic medical device bearing a CE mark – Article 70(2) IVDR.

Some performance studies require two forms of review, one from a National Competent Authority for in vitro diagnostic medical devices (JAZMP) and another from Research Ethics Committee. In Slovenia an ethics opinion can be sought from the Komisija Republike Slovenije za medicinsko etiko (KME RS). Further information can be found on the KME RS website.

The IVDR describes the operation of an electronic database underpinning a number of functions within the regulation of in vitro diagnostic medical devices in Europe (known as ‘EUDAMED’). As the EUDAMED modules applicable for performance studies are not yet functional, guidance on the application of certain provisions of the IVDR is provided in the guideline:
MDCG 2022-12 Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices).

At the time when EUDAMED is not yet available, applications for performance studies are submitted in electronic form by sending electronically to the authority’s information system or to the unified information system for the reception of applications, service and notification, which JAZMP does not currently have, therefore it is necessary to deliver the personally signed application in person at the JAZMP main office or to send it physically by post, in accordance with the second paragraph of Article 63 of the General Administrative Procedure Act (hereinafter GAP).

The international standard EN ISO 20916:2019 In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice is a useful reference when planning performance studies, which addresses good clinical practice for the design, conduct, recording and reporting of performance studies carried out using specimens from human subjects to assess the safety or performance of in vitro diagnostic medical devices for regulatory purposes.

Pursuant to the IVDR, the sponsor shall enter and submit an application for performance study. The sponsor can also authorize a representative, who must submit a valid authorization (power of attorney) in accordance with Article 53 of the GAP.

TYPES OF PERFORMANCE STUDIES

In all cases, the general requirements of Article 57 of the IVDR apply to performance studies.

ARTICLE 58 IVDR – ADDITIONAL REQUIREMENTS FOR CERTAIN PERFORMANCE STUDIES
The additional requirements specified in Article 58 apply to performance studies conducted for one or more of the purposes specified in Article 58(1-2), that is a study:
  • in which surgically invasive sample-taking is done only for the purpose of the performance study;
  • that is an interventional clinical performance study as defined in point (46) of Article 2;
  • where the conduct of the study involves additional invasive procedures or other risks for the subjects of the studies; or
  • involving a companion diagnostic.

Sponsors of performance studies being undertaken for the purposes listed above, for devices of all risk classes (Class A to Class D), should apply to the JAZMP before conducting the performance study in Slovenia. The requirements and expectations for these performance studies are detailed in Articles 58-77 of the IVDR, along with Annex XIII and XIV.

ARTICLE 58(2) IVDR – PERFORMANCE STUDIES INVOLVING COMPANION DIAGNOSTICS USING ONLY LEFT-OVER SAMPLES

Performance studies conducted in Slovenia involving a companion diagnostics where the study is performed using left-over samples only are required to be notified to the JAZMP in accordance with Article 58(2) of the IVDR.

The sponsor or his representative notifies the performance study to the JAZMP with an application on the form (in preparation):
  • indicate the email address for sending the fee payment notification;
  • attach a positive opinion of the KME RS.
ARTICLE 70(1) IVDR – PERFORMANCE STUDIES REGARDING DEVICES BEARING THE CE MARKING
Where a device CE marked under the IVDR is used within its intended purpose in a performance study, the IVDR requires that sponsors assess whether subjects will be submitted to additional procedures that are deemed invasive or burdensome (in addition to those performed under the normal conditions of use of the device). Where this is the case, the sponsor must notify the JAZMP at least 30 days prior to commencing the study in Slovenia. The sponsor is expected to notify the JAZMP of their intention to undertake that performance study and is expected to include, along with the notification, the documentation referenced in Article 70(1) of the IVDR, namely by applying on the form (in preparation):
  • indicate the email address for sending the fee payment notification;
  • submit appropriate documentation in accordance with Article 70(1) of the IVDR;
  • attach a positive opinion of the KME RS.
ARTICLE 70(2) IVDR – PERFORMANCE STUDIES OUTSIDE THE INTENDED PURPOSE OF AN IN VITRO DIAGNOSTIC MEDICAL DEVICE BEARING A CE MARK

Where a performance study is to be conducted to assess a device, CE marked under the IVDR where the study is outside the scope of the device’s intended purpose, in accordance with Article 70(2), Articles 58-77 also apply.

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