GENERAL
The clinical investigation of a medical device means any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device. It should be noted that this definition encompasses the use of both non-CE marked and CE marked devices.
- Clinical investigations conducted to demonstrate conformity of devices (for medical devices that do not bear the CE marking) – Article 62 of the MDR;
- Clinical investigations regarding devices bearing the CE marking (investigation in the context of post-market clinical follow-up (PMCF investigation)) – Article 74 of the MDR;
- Clinical investigations not performed pursuant to any of the purposes listed in Article 62(1) of the MDR (other clinical investigations) – Article 82 of the MDR;
- Clinical investigations of medical devices without an intended medical purpose (Annex XVI to the MDR).
Further information on clinical investigations is available on the European Commission’s website under the section: Guidance – MDCG endorsed documents and other guidance https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en#sec4.
The European Commission has also published a Q&A document regarding clinical investigations – Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation.
On 19 June 2025, the Medical Devices Act (Official Gazette of the Republic of Slovenia [Uradni list RS], No 40/25, as amended, hereinafter: ZMedPri-1) became applicable in Slovenia, imposing additional national requirements on clinical investigations conducted in Slovenia.
The sponsor of a clinical investigation must submit an application or notification to the EU Member State(s) in which the clinical investigation is to be conducted, accompanied by the documentation referred to in Chapter II of Annex XV to the MDR. The application or notification must be submitted by means of the electronic system referred to in Article 73 of the MDR. The procedure for notifying a clinical investigation to the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP) is described below. This procedure will be used until the Clinical Investigations Module is made available in the European Database on Medical Devices (EUDAMED).
The MDCG 2021-1 Rev.1 guidance provides further instructions on applying certain provisions of the MDR during the period when EUDAMED is unavailable. Until EUDAMED is fully functional, the EU-wide unique single identification number for the clinical investigations, used for all relevant communication relating to them, is the CIV-ID. The CIV-ID is a unique identification number, currently used for the Eudamed 2 electronic system. It supports Council Directive 93/42/EEC on medical devices (MDD) and Council Directive 90/385/EEC on active implantable medical devices (AIMDD).
While EUDAMED is not yet available, applications for clinical investigations are to be submitted electronically to the relevant authority’s information system or to the central information system for the receipt of applications, service and notifications. As this system is currently unavailable to the JAZMP, applications must be signed by hand and either submitted in person to the JAZMP head office or sent by post, in accordance with paragraph two of Article 63 of the General Administrative Procedure Act (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 24/06 – official consolidated version, as amended, hereinafter: ZUP). Alternatively, applications may be submitted electronically and signed with a qualified digital certificate. If the person signing the application is not the sponsor’s statutory representative, an appropriate mandate must be attached to the application. The JAZMP also accepts printed and hand-signed cover letters, while the remaining documentation, complete with the necessary signatures, may be submitted on a USB drive.
The MDR sets out rules regarding the content of applications, the assessments conducted by EU Member States and ethics committees, and the conduct and reporting obligations of sponsors. Clinical investigations of medical devices may begin once a favourable opinion has been obtained from the national competent authority for medical devices (the JAZMP) and from the Slovenian National Medical Ethics Committee (hereinafter: KME RS). For further information on the KME RS, please visit this website.
The principles of the clinical investigation of medical devices are set out in the international standard EN ISO 14155: 2020 Clinical investigation of medical devices for human subjects – Good clinical practice (ISO 14155:2020). The document outlines good clinical practice for designing, conducting, recording and reporting of clinical investigations involving human subjects, with the aim of assessing the safety and performance of medical devices.
CLINICAL INVESTIGATION TYPES
ARTICLE 62 OF THE MDR – CLINICAL INVESTIGATIONS CONDUCTED TO DEMONSTRATE THE CONFORMITY OF DEVICES
- to establish and verify that, under normal conditions of use, a device is designed, manufactured and packaged in such a way that it is suitable for one or more of the specific purposes listed in point (1) of Article 2 of the MDR, and achieves the performance intended as specified by its manufacturer;
- to establish and verify the clinical benefits of a device;
- to establish and verify the clinical safety of the device and to determine any undesirable side-effects, under normal conditions of use of the device, and assess whether they constitute acceptable risks when weighed against the benefits to be achieved by the device.
Where a clinical investigation is to be conducted to assess, outside the scope of its intended purpose, a device which already bears the CE marking, such investigation is considered in the same way as a clinical investigation of a medical device not bearing the CE marking.
Prior to carrying out a clinical investigation in the Republic of Slovenia, sponsors of clinical investigations conducted for the above-mentioned purposes and for devices of all risk classes (class I to class III), must submit an application to the JAZMP. The requirements and relevant documentation for carrying out clinical investigations are detailed in Articles 62 to 81 of the MDR, Annex XV to the MDR, and paragraphs three to six of Article 7 and Article 25 of the Medical Devices Act (ZMedPri-1).
ARTICLE 74 OF THE MDR – CLINICAL INVESTIGATIONS REGARDING DEVICES BEARING THE CE MARKING
Where a device bearing the CE marking is used in a clinical investigation within the scope of its intended purpose, the sponsor must assess whether this investigation will also lead to submitting subjects to additional procedures that are considered invasive or burdensome. In this case, the sponsor must notify the JAZMP at least 30 days before the start of the investigation and include the documentation referred to in Article 74 of the MDR as part of the notification.
ARTICLE 82 OF THE MDR – REQUIREMENTS REGARDING OTHER CLINICAL INVESTIGATIONS
Clinical investigations conducted in accordance with Article 82 of the MDR are subject to Article 26 of the Medical Devices Act (ZMedPri-1). The sponsor of such a clinical investigation must notify the JAZMP of the investigation via the JAZMP information system.
As the JAZMP does not currently have an information system for this purpose, notifications must be submitted in person at the JAZMP’s head office or sent by post, in accordance with paragraph two of Article 63 of the General Administrative Procedure Act (ZUP). Alternatively, applications may also be submitted electronically and signed with a qualified digital certificate. If the person signing the application is not the sponsor’s statutory representative, an appropriate mandate must be attached to the application. The JAZMP also accepts printed and hand-signed cover letters, while the remaining documentation, complete with the necessary signatures, may be submitted on a USB drive.
- the application form referred to in Chapter II of Annex XV to the MDR, containing the information required under Sections 1.1, 1.2, 1.3, 1.4, 1.6, 1.9, 1.11, 1.14 and 1.16;
- the information required under Sections 4.3, 4.4 and 4.5 of Annex XV to the MDR;
- a clinical investigation plan containing information referred to in Section 3 of Chapter II of Annex XV to the MDR.
The sponsor may start the clinical investigation of devices immediately after the validation date of the application, provided that the KME RS has not issued a negative opinion.
EUROPEAN LEGISLATION, GUIDANCE AND STANDARDS – CLINICAL INVESTIGATIONS UNDER THE MDR
Links to European guidance and other documents related to clinical investigations under the MDR are provided below. All enquiries regarding clinical investigations may be submitted by email to the following address: .
Regulation – 2017/745 – EN – Medical Device Regulation – EUR-Lex
MDCG 2019-9 Rev. 1 Summary of safety and clinical performance
MDCG 2020-5 Guidance on clinical evaluation – Equivalence
MDCG 2020-6 Guidance on sufficient clinical evidence for legacy devices
MDCG 2020-7 Guidance on post-market clinical follow up (PMCF) plan template
MDCG 2020-8 Guidance on post-market clinical follow up (PMCF) evaluation report template
MDCG 2020-10/1 Rev. 1 Guidance on safety reporting in clinical investigations in Appendix: Clinical investigation summary safety report form
MDCG 2020-13 Guidance on clinical evaluation assessment report
MDCG 2021-1 Rev. 1 Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional
MDCG 2021-6 Regulation (EU) 2017/745 – Questions and Answers regarding clinical investigation
MDCG 2021-8 Clinical investigation application / notification documents
MDCG 2021-28 Substantial modification of clinical investigation under Medical Device Regulation
2023/C 163/06 COMMISSION GUIDANCE on the content and structure of the summary of the clinical investigation report
MDCG 2023-7 Practical application of Articla 61(4)-(6) sufficient level of access
MDCG 2024-3 Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices
MDCG 2025-5 Guidance on the Investigator’s Brochure contentMDCG 2024-10 Clinical evaluation of orphan medical devices
MDCG 2024-15 Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED
