Swissmedic, a Swiss Agency for Therapeutic Products, has published an information sheet dedicated to performance studies with in vitro diagnostic (IVD) medical devices. The document provides additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers and other parties involved in order to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. The authority also reavers the right to make changes to the document and information provided therein, should such changes be reasonably necessary to reflect corresponding changes to the underlying legislation.
In particular, the document describes in detail the requirements set forth under the new legal framework entering into force on May 26, 2022, and highlights the key points related to the authorization process, as well as reporting requirements for the parties responsible for clinical investigations (sponsors) should comply with and surveillance activities are undertaken by the authority. It is important to mention that the aspects related to general (non-IVD) medical devices are falling outside the scope of the present guidance and are addressed separately in another document issued by Swissmedic.
The country’s legal framework for biomedical research is based on the Swiss Human Research Act (HRA), which in its turn incorporates the appropriate internationally recognized principles required to ensure that:
- The investigational medical device must demonstrate a sufficient stage of development for its intended use on humans;
- The investigation must satisfy scientific and ethical criteria;
- The dignity, personality, and health of human subjects must be protected.
The scope of products addressed in the present guidance includes, inter alia, reagents, calibrators, control materials, kits, instruments, apparatus, etc.
First of all, the document provides a brief overview of the existing regulatory framework in order to assist the parties involved in interpreting and following the requirements set forth therein. At the same time, the authority additionally emphasizes the importance of adhering to the provisions of the regulations themselves – in case of any discrepancies with recommendations provided herein, provisions of the applicable legislation will prevail.
According to the guidance, the current regulatory framework for IVD studies includes:
- Swiss Federal Act on Research Involving Human Beings (Human Research Act, HDA);
- Swiss Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA);
- Swiss Ordinance on Clinical Trials with Medical Devices (ClinO-MD);
- Ordinance on human research with the exception of clinical trials (HRO).
As further explained by the authority, the abovementioned regulations significantly rely on the requirements set forth by the Regulation (EU) 2017/746 (IVDR), as well as implementing regulations associated thereto (for instance, the ones addressing the aspects related to specific classes or types of medical devices). The authority additionally emphasizes that since English is not the one of official languages, any translation in English should not be considered official and binding.
Apart from the regulations, the parties involved in clinical performance studies should take into considerations recommendations and guidelines issued by the Swiss regulating authority, cantonal ethics committees, as well as the relevant international standards and conventions (namely, Declaration of Helsinki, Biomedicine Convention, Additional Protocol by the Council of Europe to the Biomedicine Convention, CIOMs Guidelines, etc).
For instance, ISO 20916 outlines the key principles for clinical performance studies related to in vitro diagnostic devices with the specimens from human subjects used. In particular, it defines internationally recognized terms, describes the content of the documents necessary and the obligations of involved persons, as well as ethical considerations, study planning, site initiation, conduct, close-out, and auditing. It is also important to mention that in the case of clinical trials with relatively low risk, certain deviations would be acceptable, specifically in post-market trials. At the same time, the authority additionally emphasizes that such deviations should not affect the safety of patients, as well as the accuracy and reliability of the data collected in the course of a study. Thus, a party responsible for a clinical trial should assess compliance with the applicable standard and indicate any and all deviations taking place in the Clinical Performance Study Plan (CPSP), list of standards, or the appropriate authorization application form.
Terms and Definitions
In order to assist the parties involved in ensuring compliance with the requirements set forth in the aforementioned regulations, the authority further provides additional clarifications regarding the way authorization for commencing performance studies involving in vitro diagnostics medical devices should be obtained.
First of all, the document describes the existing study categories and indicates the authorities responsible for them. The guidance also provides definitions of the most important terms and concepts used in the context of performance studies including, inter alia, the following ones:
- Performance study stands for a study undertaken to establish or confirm the analytical or clinical performance of an IVD;
- An interventional performance study is a performance study where the test results may influence patient management decisions and/or may be used to guide treatment.
In summary, the present guidance issued by Swissmedic provides an overview of the existing regulatory framework for performance studies involving in vitro diagnostic medical devices. The document describes in detail the applicable regulations and also highlights certain specific aspects to be considered by the parties responsible for performance investigations in this respect.
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