Clinical trials with medical devices: Expected changes in the legal requirements and BASEC
On May 26, 2021, the Medical Device Regulation (MDR at EU level) and in Switzerland the Ordinance on clinical trials with medical devices (ClinO-MD) will come into force. Accordingly, new requirements will be placed on clinical investigations with medical devices, including investigations on proof of efficacy and safety of medical devices. Hence, many additional documents must be submitted to the ethics committees.
In general, clinical investigations of category C (C1, C2, C3) must be submitted to the ethics committees and to Swissmedic, whereas clinical trials of category A (A1, A2) and research projects that fall under the Human Research Ordinance (HRO Chap.2) must only be submitted to the ethics committees.
The FOPH's Coordination Office for Human Research (kofam) has communicated how the transition is to be regulated (link kofam).
Here is a summary of the most important points:
Pending applications involving medical devices should be completed as quickly as possible. It is recommended that the necessary corrections be submitted to the competent authorities without delay, so that it is possible to conclude the procedure before MDR/ClinO-MD come into force.
From mid-April, the new protocol template (clinical investigation plan) for clinical investigations with medical devices for submission to the ethics committees according to MDR/ClinO-MD will be available on the swissethics homepage.
BASEC will be ready for submission according to MDR/ClinO-MD as early as May 1, 2021. All documents according to MDR/CliO-MD can then be uploaded and submitted.
For reasons of procedural economy, it is strongly recommended to use only the new documents according to MDR/ClinO-MD for submissions done after May 1, 2021. In this way, all requirements of the MDR/ClinO-MD valid from May 26, 2021 can be taken into account in a timely manner.
It is recommended to refrain completely from submitting applications under the old legislation as of April 1, 2021, as it cannot be ruled out that – due to the MDR/ClinO-MD requirements valid as of May 26, and the time required for the ongoing procedures – further documents will have to be submitted subsequently.
The EU documents for the notification of SAEs and device deficiencies from May 26, 2021 have already been published and will be recognised in Switzerland:
The FOPH's Coordination Office for Human Research (kofam) provides information on its page " Clinical trials with medical devices: Expected changes in the legal requirements " also provides ongoing information on the changes which are relevant in practice (Link).