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.