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Safety reporting in performance studies

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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

    All of the following shall be reported

    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 1 and 2. 

    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 subject to Article 70.1 of IVDR, 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

    There are yet no common guidance or reporting templates for safety reporting in performance studies in the EU/EEA. The following applies for safety reporting to NOMA:

    • Reports shall be submitted using the ‘manufacturer incident report’ (MIR) template. The sponsor shall fill in the following sections:

      • 1.2 a), b), c)

      • ​1.3.1 b)

      • 2.3 f), i), j) (if relevant for the device)

      • 3.1 a)

      • 3.2 b), d), f)

      • 3.3 b), c), e)

      • 4.1 a), b), c)

    The sponsor must take the definitions and requirements of Article 76 into account when describing the reportable event. ​

    • ​Reportable events shall be reported without delay to NOMA. The reporting period shall take into account the severity of the event. Where necessary to ensure timely reporting, the sponsor may submit an initial report that is incomplete followed up by a complete report.

    Submit the MIR-form by e-mail to kki@noma.no. 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

    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

    Any adverse event that led to any of the following:

    • ​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,

    • death,

    • 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:

      • ​life-threatening illness or injury,

      • permanent impairment of a body structure or a body function,

      • hospitalisation or prolongation of patient hospitalisation,

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

      • chronic disease,

      • foetal distress, foetal death or a congenital physical or mental impairment or birth defect

    Device deficiency

    Means 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

     

    Safety reporting in performance studies started before 26 May 2022

    Ongoing performance studies that were started before the implementation of the IVDR will from 26 May 2022 be subject to the safety reporting requirements of the IVDR. This means that any reportable event according to article 76 of the IVDR that occurred after 26 May 2022 shall be reported in line with Article 76 of the IVDR.

    The Manufacturer Incident Report form shall be used for safety reporting in performance studies started before 26 May 2022. The following sections of the form shall be filled in: 

    • ​1.2 a), b), c)

    • 1.3.1 b)

    • 1.3.2 (all sections)

    • 2.3 a), b), f), i), j)

    • 2.4 b), c)

    • 2.6 (all sections)

    • 3.1 a)

    • 3.2 b), d), f)

    • 3.3 b), c), e)

    • 4.1 a), b), c)

    The form shall be submitted by e-mail to kki@noma.no​.​

    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