Performance studies

 

Performance study means a study undertaken to establish or confirm the analytical or clinical performance of an in vitro diagnostic medical device. 

On 26 May 2022, the new Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices (hereinafter: the IVDR), as amended, became applicable in the Republic of Slovenia (hereinafter: Slovenia) and the European Union. The Regulation also applies to performance studies. 

In vitro diagnostic medical device (hereinafter: device) means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following: 
  • concerning a physiological or pathological process or state;
  • concerning congenital physical or mental impairments; 
  • concerning the predisposition to a medical condition or a disease; 
  • to determine the safety and compatibility with potential recipients;
  • to predict treatment response or reactions;
  • to define or monitoring therapeutic measures.

Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices. 

The scientific validity data, the analytical performance data and the clinical performance data form the basis of the confirmation of conformity with the general safety and performance requirements of the device under the normal conditions of its intended use, the evaluation of the interferences and cross-reactions and of the acceptability of the benefit-risk ratio. Based on the clinical evidence obtained in the studies, the manufacturer must demonstrate conformity with the relevant general safety and performance requirements in view of the characteristic of the device and its intended purpose. Clinical evidence must support the intended purpose of the device. It must be based on a performance evaluation process that follows a well-defined and methodologically sound procedure to demonstrate the scientific validity, analytical and clinical performance. All this information constitutes part of the technical documentation of the device concerned. The performance evaluation and its documentation must be updated throughout the life cycle of the device concerned and not only before the corresponding certificate is obtained. The regulatory requirements for performance studies therefore differ depending on the purpose of each performance study.  Provisions on clinical evidence, performance evaluation and performance studies are set out in Chapter VI of the IVDR (Articles 56 to 77). Supporting documents adopted by the Medical Device Coordination Group (MDCG) are available on the European Commission website under Guidance – MDCG endorsed documents and other guidance. 

A performance study is considered to be conducted in Slovenia if: 
  • the performance study site is located in Slovenia; or 
  • the subjects participating in such performance studies or samples for the performance study originate from Slovenia. 
Article 57 of the IVDR stipulates all performance studies must meet the following general requirements: 
  • The manufacturer shall ensure that a device for performance study complies with the general safety and performance requirements set out in Annex I apart from the aspects covered by the performance study and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the patient, user and other persons.
  • Where appropriate, performance studies shall be performed in circumstances similar to the normal conditions of use of the device. 
  • Performance studies shall be designed and conducted in such a way that the rights, safety, dignity and well-being of the subjects participating in such performance studies are protected and prevail over all other interests and the data generated are scientifically valid, reliable and robust. 

Performance studies, including performance studies that use left-over samples, shall be conducted in accordance with applicable law on data protection. 

In addition to meeting the requirements set out in Article 57 of the IVDR, certain performance studies must also comply with the additional requirements of Article 58. Specifically, these studies must be designed, authorised, conducted, recorded and reported in accordance with Article 58, Articles 59 to 77 and Annex XIV to the IVDR, as well as meeting the requirements referred to in Article 57 and Annex XIII. These include performance studies: 
  • in which surgically invasive sample-taking is done only for the purpose of the performance study; 
  • that are interventional clinical performance studies as defined in point (46) of Article 2; or 
  • where the conduct of the study involves additional invasive procedures or other risks for the subjects of the studies; 
  • referred to in Article 58(2) of the IVDR involving companion diagnostics, where left-over samples are not solely used; 
  • referred to in Article 70(2) of the IVDR, outside the scope of the intended purpose of a device which already bears the CE marking. 

Interventional clinical performance study means a clinical performance study where the test results may influence patient management decisions and/or may be used to guide treatment. 

Companion diagnostic means a device which is essential for the safe and effective use of a corresponding medicinal product to:  
  • identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or 
  • identify, before and/or during treatment, patients likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal product. 

All performance studies involving particularly vulnerable groups of subjects (e.g. incapacitated subjects, minors, pregnant or breastfeeding women) and all performance studies conducted in emergency situations must adhere to the provisions of Articles 60 to 62 and Article 64 of the IVDR. 

Performance studies referred to in Article 58(2) of the IVDR that involve companion diagnostics and do not use solely left-over samples, as well as performance studies regarding devices bearing the CE marking (i.e. studies within the scope of post-market performance follow-up – PMPF studies) that adhere to the provisions of Article 70(1) of the IVDR, must be notified to the competent authority at least 30 days prior to their commencement. 

Important: Article 70 of the IVDR explicitly lays down the conditions for conducting a performance study for the further assessment of a device which already bears the CE marking in accordance with Article 18(1), i.e. the CE marking in accordance with the IVDR. Taking into account the fact that the transitional provisions of the IVDR do not stipulate that CE markings issued under the Directives are equivalent to those issued under Article 18(1) of the IVDR, and in the absence of a decision by the Court of Justice of the European Union equating the aforementioned CE markings, the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP) interprets Article 70 as applying solely to the further assessment of devices that have obtained a CE marking under the IVDR. 

Furthermore, the Medical Devices Act (Official Gazette of the Republic of Slovenia [Uradni list RS], No 40/25; hereinafter: ZMedPri-1), which became applicable on 19 June 2025, regulates the field of in vitro diagnostic medical devices, among other things. The Medical Devices Act (ZMedPri-1) imposes additional national requirements regarding performance studies in Slovenia, as specified in paragraphs three to six of Article 7 and Article 27. 

Both, the IVDR and the Medical Devices Act (ZMedPri-1) determine the content of applications to be assessed by EU Member States, the need to obtain opinions from national ethics commissions/committees, and sponsors’ obligations regarding conduct and reporting. Sponsors/applicants must contact the Slovenian National Medical Ethics Committee (hereinafter: KME RS), which operates under the Ministry of Health of the Republic of Slovenia, for opinions concerning the ethics of performance studies. All information regarding the procedure for obtaining the KME RS opinion is available on the website. 

The international standard EN ISO 20916:2024 In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice provides useful guidance on planning performance studies. It sets out good clinical practice for designing, conducting, recording and reporting of performance studies using specimens from human subjects to evaluate the safety or performance of devices. 

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