Safety reporting in performance studies
Published:
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Updated:
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.
Adverse events that occur during a performance study must be registered and reported in accordance with IVDR Article 76. Serious adverse events and device deficiencies must be reported to NOMA.
Page contents
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:
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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
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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
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any new findings in relation to any event referred to in points a) and b).
Types of performance studies that are subject to safety reporting requirements of Article 76
Performance studies which require an application
Safety reporting is mandatory for all performance studies that require an application to NOMA under Article 58 (1) or 58 (2).
Performance studies which require a notification
For PMPF studies that require a notification to NOMA according to IVDR Article 70 (1), reporting must follow the requirements in IVDR Article 76 (5) and 76 (6). This implies that reporting shall follow the provisions of vigilance laid down in IVDR Articles 82 to 85. This is the same reporting procedure as that of CE marked devices in normal use. Please refer to our website serious incidents with medical devices for more information. 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 IVDR Article 76.
How to submit safety reports to NOMA
Until Eudamed is available, reporting must follow the current EU guideline, using the associated reporting form:
Appendix – Performance Study Summary Safety Reporting Form
The reporting form must be submitted by email to kki@noma.no. The subject heading should include “Safety reporting in performance study”. The title of the performance study, PS-ID and information on the sponsor and a contact person for the sponsor must be provided in the email.
Please note that reportable events must be reported to all Member States in which the performance study is conducted. This includes reportable events that occur in third countries under the same clinical performance study plan.
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:
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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,
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death,
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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:
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life-threatening illness or injury,
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permanent impairment of a body structure or a body function,
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hospitalisation or prolongation of patient hospitalisation,
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medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function,
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chronic disease,
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- 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.