The new article describes in detail the approach to be applied with respect to notifications, databases, liability insurance, and other aspects related to performance studies involving in vitro diagnostic medical device
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The Swiss regulating authority in healthcare products (Swissmedic) has published an information sheet dedicated to performance studies involving in vitro diagnostic (IVD) medical devices. The document is intended to provide additional clarifications regarding the applicable regulatory requirements and recommendations to be considered by the parties responsible for investigations (study sponsors) 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 to the guidance, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Notification Requirements: End of the Study
The scope of the guidance covers, inter alia, the aspects related to the notification requirements to be followed by the study sponsors. Under the general rule, the sponsors must notify Swissmedic of the end of a performance study within 15 days (as of the last patient, last visit); while a discontinuation or an interruption of the study for reasons not related to safety, and the reasons for this, must also be notified within 15 days.
Apart from the above, a complete final report containing all the information required under the applicable regulations should be submitted to the authority within one year from the date the study has ended. The guidance also refers to the standard ISO 20916 for further details on the report’s content. It is also important to mention that if a study is temporarily suspended or terminated before the projected termination date, the report should be provided to the authority within 3 months from the respective date.
Databases and Data Retention
Another important aspect addressed in the present guidance relates to databases and data retention. First of all, the authority mentions that under the general rule, an archiving period of at least 10 years after the end of the study is required and applies to sponsors and investigators.
In terms of databases, the document refers to the European database (EUDAMED system), which is expected to be fully operational in 2023. At the same time, access of the Swiss regulating authority to the said database could be postponed at a certain point. Thus, until further notice, the sponsor has an obligation to submit requests and reports via the Swissmedic portal eMessage, including information about different CPSP versions used abroad or safety measures taken abroad, such as study interruptions and early terminations on safety grounds. Apart from the above, the BASEC system should be used for submissions to cantonal ethics committees.
Foreign Sponsors
The document also describes the approach to be applied if a sponsor has a registered office abroad. Under the general rule, such sponsors are obliged to appoint an agent domiciled or having its place of business in Switzerland, and the address of this agent will be used for official correspondence – the authority will send all the decisions and invoices to the agent. Existing legislation provides that legal and natural persons could be appointed agents.
In terms of submissions, the authority will accept the ones made by:
- A sponsor, or
- A third party acting on behalf of a sponsor, for example, a clinical research organization (when an application for authorization is submitted, all third parties should be listed in the application form).
Liability and Insurance
The scope of the guidance also covers the aspects related to liability. According to the guidance, an insurance company headquartered in Switzerland or with a branch office in Switzerland can offer acceptable coverage as the subjects can assert their legal right of direct claim and the associated legal enforcement claims within Switzerland. A cantonal ethics committee will check the fulfillment of the corresponding obligation. Cantonal ethics committees, including the insurance policy templates, have published detailed requirements related to insurance.
Adverse Events Recording
The information sheet published by Swissmedic also contains an annex dedicated to recording adverse events and device deficiencies identified during a performance investigation. In accordance with the applicable regulations, a study sponsor is obliged to prepare adequate case report forms. The study center initially fills in a case report form and should comply with the risk management and reporting requirements for adverse events and study deficiencies.
The scope of information to be provided shall cover, inter alia, the following aspects:
- Details about the study, including its title and name of a study sponsor,
- Study sites and patients involved,
- Dates,
- Criteria for seriousness (e.g., a serious deterioration in the health of the individual being tested),
- Action/treatment/patient outcome,
- Relationship of the event reported to the procedure (e.g., not related, possible/unknown, probable, or causal relationship),
- Relationship to a medical device in question,
- Expectedness (e.g., anticipated or unanticipated),
- Investigation arm (e.g., investigation arm or comparator arm),
- Outcome (e.g., ongoing or resolved).
In summary, the present information sheet issued by Swissmedic highlights the most important aspects to be considered by study sponsors responsible for performance studies with in vitro diagnostic medical devices. The document provides an overview of the applicable regulatory requirements and outlines specific points related to the responsibilities of the sponsors.
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