Swissmedic, the Swiss regulating authority in the sphere of medical devices, has published an official notice describing upcoming changes in applicable regulatory requirements. The announced changes related to the procedures to be performed when placing new medical devices on the market will become effective on May 1, 2021.
Upcoming Changes: an Overview
The official notice published by Swissmedic provides a short overview of the most important changes to applicable regulatory requirements that will take place in May 2021. First, the authority mentions that starting from May 1, 2021, all new submissions related to medical devices should be submitted simultaneously to the regulating authority itself, and also to the responsible cantonal ethics committee. Starting May 26, 2021, the regulating authority will permit trials only if there is an approval of the ethics committee in place. Swissmedic additionally emphasizes that such approval should be granted with regard to the same version of the trial documentation.
The upcoming changes will also affect the submission filing process itself. In particular, Swissmedic announced the new forms to be introduced closer to the date. The submission folder structure will also be subject to change. However, according to the official notice, the applicants will still have to use the eMessage portal for filing submissions to the regulating authority itself and BASEC for filings addressed to the ethics committee.
Swissmedic also announces certain changes to the regulatory requirements for investigational devices for which, under the applicable regulations, the CE marking requirements could be waived. According to the notice, starting May 26, 2021, the requirements set forth by Annex 1 to the Medical Device Regulation 2017/745 (MDR) would become applicable for investigational devices as well. It is important to mention that for applications that are currently under review, additional documentation should be submitted. The regulating authority encourages the applicants to submit such additional documentation in advance to avoid delays. In order to assist the applicants and all the parties involved, the regulating authority also provides a list of applicable standards and requirements.
The changes will also affect the regulatory requirements in terms of adverse event reporting. In particular, current requirements prescribed by the MEDDEV 2.7/3 will be replaced by the ones set forth under the Medical Device Regulation.
New Regulatory Requirements in Detail
The official notice published by Swissmedic also refers to the corresponding publication made by the Coordination Office for Human Research (Kofam) operated by the Federal Office of Public Health – a body responsible for the coordination of human research in the country and accessibility of important information.
The Kofam notice is focused on changes to the regulatory requirements for clinical trials. In this regard, Kofam states that once the changes take effect, clinical studies related to medical devices will be subject to regulation under the new medical device regulation (ClinO-MD, as described below) which takes effect on May 26, 2021, together with the aforementioned Medical Device Regulation. At the same time, the regulatory requirements for clinical trials related to in vitro diagnostic medical devices fall outside the scope of the new regulation.
In order to assists the applicants and other parties involved in clinical trials related to medical devices in achieving and sustaining compliance with the new regulatory requirement, Kofam outlines the most important aspects to be considered, namely:
1. Submitting the application for a clinical trial. First of all, the applicant may submit all remaining documents within the shortest possible period of time. In this case, there is a chance that the review of the application will be completed before the new requirements become applicable. Starting May 1, 2021, all new applications should be submitted strictly in accordance with the new regulatory requirements to be introduced by the ClinO-MD. In particular, the applicant will have to use new forms and follow amended procedures in order to accelerate and facilitate the review of the submission.
2. Scope of the new regulatory requirements. The new rules, which will take effect in May 2021, will address aspects related to clinical trials with medical devices of all types except in vitro diagnostic ones, as well as clinical trials related to certain products without a medical purpose. At the same time, the clinical trials with in vitro diagnostic medical devices will be subject to regulation under the ClinO for an additional year.
3. Submission procedure. According to the notice, the process of submitting an application for clinical trials will remain intact. The applicant can still use the appropriate electronic system. It is also important to mention that the new EU-wide database for medical devices – EUDAMED[1] – is still unavailable.
4. The regulatory status of clinical trials already approved before the new requirements take effect. As it is stated in the official publication, all authorizations granted under the previous framework remain valid. At the same time, the clinical trials themselves should be conducted in accordance with the new requirements, especially in terms of adverse event reporting. Additionally, the results of any and all clinical trials completed after the new regulatory requirements take effect should be published in the appropriate register.
Kofam states that additional information related to regulatory requirements for registration and publication in study registries, categorization of clinical trials with medical devices, as well as differentiation between clinical trials will be published later.
New Ordinance on Clinical Trials With Medical Devices
As stated by Swissmedic, the upcoming changes are intended to align the regulatory approach with the one applied in the EU under the new Regulations. As part of this harmonization process, the new “Ordinance on clinical trials with medical devices (ClinO-MD[2] )” will be introduced. The new Ordinance will constitute a single document covering all important aspects related to clinical trials with medical devices. According to the official publications, preliminary consultations regarding the new regulatory approach took place earlier in 2019. The changes were initially expected to take effect in May 2020, but the actual implementation date has been rescheduled for an additional year due to the impact caused by the outbreak of the Coronavirus Disease 2019 (COVID-19) caused by the virus SARS-CoV-2 or the “novel coronavirus”, as well as additional quarantine and travel restrictions associated thereto.
However, as mentioned before, the scope of the upcoming changes covers only the clinical trials with general medical devices, while the ones with in vitro diagnostic medical devices will still be regulated under the existing framework. At the same time, the authority intends to commence public consultations regarding the inclusion of in vitro diagnostic medical devices in the scope of the new regulation.
In summary, the official notices published by Swissmedic and Kofam describe the most important changes to the regulatory requirements for clinical trials with medical devices to be introduced later in May 2021. The changes will affect the initial application process, as well as the adverse event reporting rules. The notices also outline the most important aspects to be considered by all the parties involved in clinical trials.
For more information about MedO and ClinO Medical Device Ordinances click HERE
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Sources:
https://ec.europa.eu/health/sites/health/files/md_sector/docs/mdcg_2021-2_en.pdf
