The new document describes in detail the aspects related to the existing types of clinical trials, as well as the way an interested party should submit an application.
Switzerland’s regulating authority in the sphere of healthcare products, Swissmedic, has published an information sheet dedicated to performance studies related to in vitro diagnostic (IVD) medical devices. The document provides an overview of the regulatory requirements set forth under the existing framework, 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 reserves the right to make changes thereto, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
The scope of the guidance covers, inter alia, the aspects related to the authorization of performance studies with IVDs involved.
First of all, the authority mentions that the existing regulatory framework distinguishes different types of studies that could be conducted. In order to assist medical device manufacturers in interpreting the respective regulatory requirements when determining the regulatory nature of the studies in question, the authority provides a flowchart describing the decision-making process in detail and provides additional clarifications in this respect. Furthermore, it is also stated that in case of any doubts, manufacturers/study sponsors are encouraged to get in touch with the relevant cantonal ethics committee for further assistance and guidance.
When determining the regulatory nature of the study and the approach to be applied in this respect, the following questions are to be answered:
- Is the IVD under investigation or will it just be used during the research project? In this respect, the authority mentions that medical devices initially intended for research use only (RUO) are not subject to regulation under the IVD framework, and should not be used for medical decisions. Moreover, the research activity in which they are being used should be duly authorized as required under the respective legislation.
- Will individual test results be disclosed to the subjects or to professionals in charge of subjects? In case the results are not supposed to be used for a clinical decision-making process in Switzerland, but would be transferred abroad instead, no approval will be required.
- Will there be patients/subjects in Switzerland? Similar approach applies in case there are no patients managed in Switzerland – no involvement of Swissmedic will be required.
- Does the study plan prescribe the choice and use of IVD? A study could be related to a medical device already allowed for marketing and use in the country. The authority additionally emphasizes the prohibition to promote, suggest or investigate off-label use in an observational study.
- Is the IVD CE-marked? Depending on the study category, the involvement of Swissmedic could be required, as well as the involvement of the ethics committee.
- Will it be used according to the CE-marked instructions for use (on-label use)? Should the off-label use be expected, a party responsible for a study should the same day apply for authorization to be issued by Swissmedic, and also submit the appropriate application to the ethics committee.
- Has the IVD been prohibited in Switzerland? In the absence of prohibition, the device could be approved for marketing and use in the country. At the same time, should such a prohibition be introduced, the device in question cannot be placed on the market or used.
Category C Interventional Performance Studies
Apart from the general overview provided hereabove, the document also describes in detail the application process for authorization of category C interventional performance studies (pre-market). According to the guidance, the appropriate application form is to be submitted to the authority by an interested party using the template indicated by the authority. Such a form should contain, inter alia, an indication of the European Medical Device Nomenclature (EMDN) code that applies to the device in question.
It is important to mention that should specific conditions and criteria be met, the application could be reviewed under the simplified procedure. These conditions are as follows:
- The performance study falls under category C1 or C2 and concerns the investigation of an IVD classified as risk class A or B according to Art. 14 IvDO.
- The use of the investigational IVD is at most associated with minimal risks to the subjects.
- The investigators have agreed in written form to inform the sponsor without delay of all serious adverse events or other (new) circumstances that could threaten the safety of subjects or device users according to Art. 32 ClinO-MD.
- The sponsor has a risk management system in place to monitor safety.
As explained by the authority, in order for the eligibility for a simplified review to be checked, an interested party should complete and submit an additional form. Should the authority decide to decline such a request, the appropriate justification will be provided to the applicant by virtue of a preliminary letter. Once such a letter is received, the applicant will be entitled to provide additional clarifications and submit corrections or information the authority deems to be missing. Apart from that, the interested party may withdraw the initial request for the review under a simplified procedure and proceed with a review under the general rule – the process will be commenced by the authority once the appropriate application is submitted.
The authority additionally emphasises the importance of providing all the information required in time, while incomplete submissions could result in delays in the review process. In this respect, the authority encourages the applicants to ensure the submissions contain any and all the documents required, showing the name of the product in question and identification of exact models and versions.
In summary, the present information document issued by Swissmedic provides additional clarifications regarding the types of clinical investigations related to in vitro diagnostic medical devices. The document also highlights the key aspects to be considered with respect to applications to be submitted by interested parties when requesting approval from the authority.
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