Updates on Medical Device Regulation (ClinO-MD)
In the course of adapting Swiss legislation to the new EU Medical Device Regulation (MDR), clinical research with medical devices (with the exception of in vitro diagnostics) in Switzerland will be regulated in a separate ordinance. The new “Medical Device Regulation” (ClinO-MD) will come into force on May 26, 2021, at the same time as the MDR.
According to the update posted on the Swiss National Clinical Trials Portal (SNCTP) on April 20, 2021, in addition to the existing obligation to prospectively register the clinical trial, the results of the trial must now also be published in a trial registry. This will also apply to clinical trials which will be still underway when the ClinO-MD enters into force on May 26, 2021. As Eudamed cannot currently be used for this purpose, the registration and publication of results must therefore be carried out in an international trial registry, such as ClinicalTrials.gov.
Other than the disclosure requirements other changes regarding clinical trials with medical devices under the ClinO-MD are:
- Updated categorization of the medical devices
- Differentiating clinical trials as conformity-related and non-conformity-related
- Adaptation of application documents to be submitted
- Reply deadline for sponsors
For more details, please refer to Clinical trials with medical devices: Expected changes in the legal requirements.
Clinical Trials Information System (CTIS) Training: Day 1 Webinar Presentations
SME and academia Clinical Trials Information System (CTIS) two-part training webinar was announced on 19/01/2020. Day 1 of the webinar was held on 22 February 2021. Presentations were provided by EMA system experts, European Commission, and presenters from SME and academic institutions during the webinar. The presentations from the Day 1 of the CTIS training webinar were made available by EMA on 26 February 2021.
SME and academia Clinical Trials Information System (CTIS) two-part training webinar were announced on 19/01/2020. This two days training webinar would provide essential information on CTIS for micro, small and medium-sized enterprises (SMEs) and non-commercial (academic) sponsors.
Day 1 of the webinar would be held on 22 February 2021. It will cover:
- Overview of CTIS
- User access management, including how to register users
- Sponsor user management
- Sponsor roles and permissions in CTIS
Day 2 of the webinar would be held on 4 March 2021. It will cover:
- Submitting an initial trial application in CTIS
- Updating an initial trial application, including making substantial modifications and adding a Member State concerned
- Making non-substantial modifications
- Submitting trial results
Registration must be done by completing the expression of interest questions by 29 January 2021. Registrations will close on 7 February 2021. Registration for each day of the webinar must be done separately. The webinar is limited to 950 participants only. EMA will publish the video recording of the webinar.