Clinical investigations started prior to 26th May 2021
Published:
Changes
Clinical investigations started prior to 26th May 2021 can continue according to the previous regulation (MDD/AIMDD). However, safety reporting must follow the requirements in the new regulation (Medical Device Regulation, MDR).
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Safety reporting
Safety reporting must be done in accordance with MDR Article 80. More information on the reporting requirements, which events to report and how, can be found on Safety reporting in clinical investigations.
Substantial modifications
Substantial modifications to the clinical investigation must be notified to NOMA, and a confirmation from NOMA must be received before the modifications can be implemented.
End or temporary halt of a clinical investigation
NOMA must notified at the end of a clinical investigation. This also applies if the investigation has not commenced in one or more study sites.
Clinical investigation report
A clinical investigation report, as described in ISO 14155:2020 "Clinical investigation of medical devices for human subjects – Good clincal practice", must be submitted to NOMA.