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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). 

Page contents

    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.

    Contact us

    Unit for medical devices - development and notified body

    (+47) 22 89 77 00

    Questions regarding clinical trials, classification and innovation guidance

    kki@noma.no