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Safety reporting in performance studies

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Changes

  • : Revised section on how to submit safety reports to NOMA with reference to guidance on safety reporting in performance studies and the associated reporting form. Removed section on safety reporting in performance studies started before 26 May 2022.

The clinical performance study plan shall describe in detail how the safety of the subjects is to be monitored, and how adverse events are to be registered and reported. Safety reporting shall follow the requirements of Article 76 of IVDR. ​​​​​

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    ​​​​​​​​​​​The investigator is responsible for documenting and reporting the events to the sponsor. The sponsor is responsible for reporting any reportable events to the competent authorities.​

    Reporting obligations of the sponsor

    Reportable events

    The sponsor shall report all of the following without delay to NOMA, in accordance with IVDR article 76:

    1. ​any serious adverse event that has a causal relationship with the device, the comparator or the study procedure or where such causal relationship is reasonably possible

    2. any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate

    3. any new findings in relation to any event referred to in points a) and b). 

    All reportable events shall be reported to all Member States where the performance study is conducted. This includes reportable events that occur in third countries under the same clinical performance study plan. 

    Types of performance studies that are subject to safety reporting requirements of Article 76

    • ​All performance studies that require an application to NOMA under Article 58 (1) or 58 (2)

    • For PMPF studies that require a notification to NOMA under IVDR Article 70 (1), reporting of incidents shall be done through the vigilance system (IVDR Articles 82 to 85). This is the same reporting procedure as that of CE marked devices in normal use. However, if a causal relationship between the serious adverse event and the preceding performance study has been established, safety reporting shall follow the safety reporting procedure of Article 76 of IVDR (i.e. as described above).

    How to submit safety reports to NOMA

    Until EUDAMED is fully functional, reporting must follow current EU guidelines, using the associated reporting form:

    MDCG 2024-4 Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746

    Appendix – Performance Study Summary Safety Reporting Form

    Submit the form by e-mail to kki@noma.no. The subject heading should include “Safety reporting in performance study”. The title of the performance study, PS-ID and contact details of a contact person for the sponsor must be provided in the e-mail. 

    Definitions

    Adverse event

    Adverse events are defined in IVDR Article 2 (60) as any untoward medical occurrence, inappropriate patient management decision, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a performance study, whether or not related to the device for performance study

    Serious adverse event

    Serious adverse events are defined in IVDR Article 2 (61) as any adverse event that led to any of the following:

    1. ​a patient management decision resulting in death or an imminent life-threatening situation for the individual being tested, or in the death of the individual's offspring,

    2. death,

    3. serious deterioration in the health of the individual being tested or the recipient of tested donations or materials, that resulted in any of the following:

      1. ​life-threatening illness or injury,

      2. permanent impairment of a body structure or a body function,

      3. hospitalisation or prolongation of patient hospitalisation,

      4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function,

      5. chronic disease,

    4. foetal distress, foetal death or a congenital physical or mental impairment or birth defect
    Device deficiency

    Device deficiency is defined in IVDR Article 2 (62) as any inadequacy in the identity, quality, durability, reliability, safety or performance of a device for performance study, including malfunction, use errors or inadequacy in information supplied by the manufacturer.

     

    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