Swissmedic Guidance on IVD Performance Trials: Modifications | RegDesk

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 itself is not intended to introduce new rules or impose new obligations, but rather to provide additional clarifications and recommendations to be followed by medical device manufacturers, study sponsors, and other parties involved in operations with medical devices and clinical investigations associated thereto. 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. 

The scope of the guidance covers, inter alia, the aspects related to modifications to clinical investigations supervised by the authority.

Modifications (Amendments): Key Points

Under the general rule, modifications to performance studies require authorization or notification of both Swissmedic as a regulating authority and the ethics committee. When preparing the submission, the party responsible for a medical device should assess the impact of modifications suggested to determine whether they are substantial. 

As further explained by Swissmedic, a responsible party will have to submit the following documents:

• A cover letter explaining the reason for the modification;

Documents affected by the modification, with all modifications compared to the earlier version highlighted in the text (the authority additionally emphasizes the importance of submitting only highlighted/track-changed versions).

Substantial Changes

In accordance with the applicable regulatory requirements, modifications that are likely to have a substantial impact on the safety, health or rights of the subjects or the robustness or reliability of the clinical data generated in the performance study must be authorized by the ethics committee and Swissmedic before they can be implemented. As explained by the authority, such changes could include, inter alia, the ones related to design and product administration, safety procedures; as well as the changes to primary or secondary study endpoints. 

The submission covering the aforementioned aspects should be filed to both the regulating authority and ethics committee on the same day. The review timeframe constitutes 38 days, the said period could also be extended by the authority for additional 7 days. The initial completeness check will take up to 10 days – within this period, the authority will either confirm the receipt of a submission or request additional information or documentation reasonably needed to complete the assessment of the proposed modifications and risks associated thereto. 

The document also describes the procedure to be followed in case of a change of sponsor. According to the applicable legislation, the appropriate submission should be filed 38 days before the date such a change is planned to take effect. The documents to be included in the said submission are:

• Cover letter signed by the previous sponsor, date when its activities in the study end, explanations about the changes;
• The completed form BW610_10_021e_FO, with all the details of the new sponsor;
• Amended study document in “Track changes” mode.

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.

Notification Procedure

As it was mentioned before, a party responsible for a clinical investigation to which the changes are to be implemented should, first of all, determine the regulatory status of such changes. In case of such changes are considered insignificant, a notification procedure should apply, while prior approval of the authority and/or ethics committee will not be required. For such changes, it will be sufficient to submit the appropriate notification to the authority. It is important to mention that the authority will not issue a manual confirmation of receipt in response (only automatic ones – for successful upload and technical validation). However, should the authority determine that the modifications described in the submission received are subject to approval, the applicant will be notified accordingly. Should it be the case, a party responsible for a clinical investigation in question should immediately cease the actual implementation of such modifications and wait for approval to be granted. It is also stated that in case of gross errors or repetition, Swissmedic may open surveillance activities and ask [the applicant] to check [its] quality assurance system and implement corrective and preventive action (CAPA) to improve submissions.

Fees

The scope of the information sheet published by Swissmedic also covers the fees payable in connection to applications for changes to performance studies. According to the respective regulations, these fees are:

• CHF 1000 – a flat fee for handling modifications that are subject to authorization; 
• Hourly rate of CHF 200 applies to additional workload caused by shortcomings regarding the documentation and corrections;
• Should an application be withdrawn by the applicant before the actual review starts, the abovementioned flat fee will not apply – only the fee based on the hourly rate;
• For a change of sponsor applications, the same hourly rate of CHF 200 applies. 

In summary, the present Swissmedic information sheet describes the regulatory requirements for modifications to performance studies to be applied based on the level of significance of the changes suggested. The document outlines the scope of information and documentation to be included in the respective submission, and also the fees payable by an interested party.

Sources:

https://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizinprodukte/mep_urr/bw600_00_016e_mb_performance_studies_with_ivd.pdf.download.pdf/BW600_00_016e_MB_Information_performance_studies_IVD_KlinVMEP.pdf  

How Can RegDesk Help?

RegDesk is a next-generation web-based software for medical device and IVD companies. Our cutting-edge platform uses machine learning to provide regulatory intelligence, application preparation, submission, and approvals management globally. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days using RegDesk Dash(TM). Global expansion has never been this simple.