The Swissmedic released (31 October, 2024) updated guidance on "Clinical Investigations with Medical Devices" and "Performance studies with IVD".
This guidance document aims to support sponsors, contract research organizations (CROs), and investigators in navigating Swissmedic’s requirements for clinical investigations involving medical devices. It provides an overview of approval processes, reporting duties, and regulatory oversight involved in these studies. The Approval Process for Clinical Investigations is summarised as below
Categories of Investigations: Studies are classified as Category A (post-market) or Category C (pre-market). Category A involves using CE-marked devices as per labeling, while Category C pertains to non-CE-marked or off-label usage.
Application Submission: Applications for Category C studies must be submitted simultaneously to both Swissmedic and the ethics committee for approval.
Special Considerations: Specific provisions are made for combined studies, radiation-emitting devices, and special groups like custom-made devices and in-house manufactured products.
Sponsors must provide regular reports to Swissmedic, including annual updates, serious adverse event reports, and device deficiency documentation. The guide outlines strict timelines for reporting serious adverse events and device deficiencies, with specific criteria for when to suspend or modify a study due to safety concerns.
A minimum data retention period of 10 years after study completion is required, extended to 15 years for implantable devices. Submissions for approval and reporting should be made through Swissmedic’s eMessage system and BASEC for ethics committees. EUDAMED, the European database, may also be used once Swiss access is established. Sponsors without Swiss offices must appoint a local agent for official correspondence. Third-party submissions, such as those by CROs, must be indicated in applications. For more details, refer to the original guidance document on Swissmedic’s official website: Clinical Investigations of Medical Devices Guide
Guidance: Performance studies with IVD
This guidance provides a comprehensive framework for the conduct, approval, and monitoring of IVD performance studies in Switzerland and is intended for sponsors, contract research organizations (CROs), and investigators involved in performance studies of IVDs under the new regulation effective as of October 31, 2024. The guidance emphasizes ethical considerations, compliance with legal standards, and adherence to good study practices in line with ISO 20916.
ISO 20916 Standard is a standard that is critical as it provides internationally recognized terms and guidelines for ethical and scientific conduct in IVD performance studies, ensuring participant safety and high data quality. The guidance includes annexes with templates for adverse event reporting, criteria for vulnerable populations, and procedures for data handling, ensuring that sponsors adhere to Swiss and international standards.
For detailed information, the full document is accessible through Swissmedic's website or directly via the provided Swissmedic link.
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