The new article highlights aspects related to electronic submissions and specific types of products.
Table of Contents
The Swiss regulatory authority in the sphere of healthcare products (Swissmedic) has published a guidance document dedicated to the regulatory requirements for performance studies involving in vitro diagnostic (IVD) medical devices. The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers, study sponsors, and other parties involved in order to ensure compliance. At the same time, provisions of the guidance are non-binding in their legal nature, and are not 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 changes to the underlying legislation.
Reflection Period
The scope of the guidance covers, inter alia, aspects related to the reflection period that study participants should be given. According to the guidance, a specific timeframe should be determined on a case-by-case basis depending on the surgical procedures conducted and the risks associated with the study in general. In this respect, the document also refers to the relevant decisions of the Federal Supreme Court.
Making a Submission
The document further provides additional clarifications regarding the way a submission should be filed by the applicant. As explained by Swissmedic, the appropriate electronic filing system – the eGovernment Service eMessage – should be used. Furthermore, the document indicates an email to be used for reporting adverse events associated with the device, its deficiencies, as well as any communications during the investigation (e.g., requesting extensions or clarifications regarding the procedure). In all other cases, the eGovernment system should be utilized.
The authority additionally emphasizes that in order for the request to be handled in a proper way, standardized forms, and folder structure should be followed by the submitter. In accordance with the respective procedure, electronic submissions consist of three steps, namely:
- Prepare the standardized form and download the standardized folder structure. For this purpose, an interested party should visit the authority’s website and download the form.
- Generate an eDok. An applicant should copy the form, a cover letter (if applicable), and all the documents related to the submission to the respective folders. Each eDok should include only one submission. In some cases, it is allowed to split the submission into several eDoks when it is reasonably necessary (this should be properly explained in the cover letter accompanying the submission).
- Submit the eDok. An eDok should be filed via the Swissmedic Portal eMessage. The authority also mentions that even though it also operates the eSubmission platform, it cannot be used for medical devices.
As further explained by the authority, in order to create an eGovernment account, an interested party will need an email address and a mobile phone. Once the registration is completed, the acompletee request could be submittcan Swissmedic. It is also important to mention that, for security reasons, a two-factor identification procedure will be conducted each time an applicant attempts to access the portal (a mobile phone will be used to receive a code).
In order to make a submission, an applicant should answer the questions appearing on the screen, and then upload an eDok containing all the documents related to the submission as described hereabove. Upon submission, an applicant will receive an automated confirmation of successful submission, followed by notification of the completion of the automatic technical validation. All communications from the authority will be stored in the eMessage account of the applicant. At the same time, the authority additionally emphasizes that the applicant should not store all the files in the portal, but rather save and store them in the trial master file, ensuring that all authorized persons will be able to access them in the course of a trial and subsequent mandatory retention period.
It is also stated that if the eDok format is not followed by the applicant, an error message will appear. Thus, it is vitally important to ensure the submission meets the format and requirements set forth by the authority for this type of submission.
Special Groups of Products and Combined Trials
The guidance also highlights the aspects related to special groups of products subject to assessment in the course of performance trials and outlines the key points to be taken into consideration by medical device manufacturers and study sponsors in this respect.
- In-house devices should be used within the premises owned by the same healthcare institution in order to address specific needs that cannot be met by similar products already on the market. The study plan should provide additional information regarding compliance with the General Safety and Performance requirements, as well as the applicable conditions of the respective regulations.
- With respect to Software as an IVD, provisions of the European guidance document MDCG 2019-11 should be considered when determining the regulatory nature of the product (whether it falls within the scope of in vitro diagnostic device regulations) and applicable risk-based classification the product is subject to.
- Combined trials are the ones involving both a medicinal product and a companion diagnostic product (IVD). According to the guidance, both the requirements set by the medicine and device frameworks should apply. The trials could be described in either one or several protocols.
In summary, the present Swissmedic guidance provides additional clarifications regarding specific aspects associated with performance trials involving in vitro diagnostic medical devices. The document describes in detail the way electronic submission systems should be used, and also clarifies the approach to be applied with respect to specific product types.
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.
