The new article addresses the aspects related to surveillance activities to be carried out by the authority, as well as the applicable reporting requirements the parties responsible for performance investigations should follow.
Table of Contents
The Swiss regulating authority in the sphere of medical devices, Swissmedic, has published an information sheet dedicated to the regulatory requirements for performance studies involving in vitro diagnostic (IVD) medical devices. The document is intended to provide additional clarifications regarding the existing regulatory framework, as well as recommendations to be taken into consideration by the 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. Moreover, the authority reserves the right to make changes to the guidance, should such changes be reasonably necessary to reflect corresponding changes to the underlying legislation.
The scope of the guidance covers, inter alia, the aspects related to review and surveillance activities conducted by the authority in order to ensure continued safety and proper performance of in vitro diagnostic devices allowed to be marketed and used in the country.
Review and Surveillance Activities: Key Points
Under the general rule, when granting approval for a performance study to be conducted, the authority assesses compliance with the General Safety and Performance Requirements, as well as the risks associated with the study and data available with respect to the product in question (it should be taken into consideration and duly reflected in the study protocol). As further explained by Swissmedic, parties responsible for interventional performance studies should implement the appropriate quality assurance system and check the following aspects:
- Whether all duties have been assigned to specific persons;
- Whether written procedures are available and up to date;
- Whether the notification duties and authorization requirements for Switzerland are correctly implemented in the written procedures;
- Whether the job descriptions of personnel are completed and up to date;
- Whether written contracts are available with external parties;
- The appropriateness of the basic and advanced training of involved personnel.
The authority also mentions that the above list is non-exhaustive and merely highlights the key points to be taken into consideration by the parties responsible for clinical investigations (sponsors).
Frequent Objections
Apart from outlining the most important aspects to be addressed in the context of the quality assurance system to be implemented by study sponsors, the authority also provides examples of the most common objections. According to the guidance, the aspects requiring the most attention are:
- Documentation related to adverse events and device deficiencies;
- Measures introduced to reduce the risk;
- Applicable inclusion and exclusion criteria, especially for vulnerable persons;
- Reflection period when consenting for invasive procedures.
Inspections
In accordance with the applicable EU legislation, national regulating authorities in the sphere of medical devices are entitled to carry out inspections in order to check compliance with the applicable regulatory requirements. A similar approach is followed by Swissmedic – the Swiss authority may also conduct such inspections to verify compliance with any and all requirements, and the scope of such studies may cover all the parties involved in performance studies, including companies, institutions, and persons. Furthermore, based on the result of an inspection, the authority may withdraw or suspend an authorization that has been granted, or make the continuation of a study dependent on additional conditions.
Submissions During Performance Studies
Another important aspect addressed in the guidance relates to submissions that could take place during an investigation. Under the general rule, during a performance study, its sponsor may send additional information to the authority or the ethics committee. It is important to mention that additional requirements could be imposed on a cantonal level, such requirements are falling outside the scope of the present guidance. The authority also states that mandatory reporting should be included as part of the quality assurance system to be developed and implemented by a study sponsor.
The document further describes in detail specific reporting requirements based on the study type and party to which the report should be provided (e.g., the authority or the ethics committee).
For instance, according to the document, specific reporting requirements apply to Category A performance studies involving in vitro diagnostic medical devices.
In the case of Category C performance studies, the stricter requirements apply. Moreover, certain actions related to the study will require prior authorization by Swissmedic before being taken by a sponsor. According to the guidance, prior authorization will be required in the case of:
- Substantial modifications (safe for the ones related to safety and protective measures – such modifications could be implemented immediately with the authority being notified without undue delay);
- Non-substantial modifications.
The document also outlines timeframes for specific reporting requirements. For example, device deficiencies should be reported to the authority within 7 days, temporary halt or early termination on safety grounds – within 24 hours, other safety and protective measures – within 2 days. Interruption and early termination on safety grounds should be reported within 24 hours, while the one which is not based on safety grounds – 15 days. The same reporting period applies to the end of the performance study in Switzerland.
The annual safety report, as well as the final report and summary for lay persons, should be provided within 1 year (if an investigation was interrupted or terminated earlier – within 3 months from the date of such termination).
In summary, the present guidance issued by Swissmedic addresses certain aspects related to reporting obligations current legislation provides for performance investigations involving in vitro diagnostic medical devices. The document also provides a general overview of surveillance activities conducted by the authority, as well as the most common grounds for objections the authority may have.
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