Safety reporting in clinical investigations
Published:
Changes
Adverse events that occur during clinical investigations must be registered and reported according to MDR Article 80. Serious adverse events and device deficiencies must be reported to NOMA.
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What to report?
The sponsor shall report all of the following without delay to the NOMA, cf. MDR Article 80:
- Any serious adverse event (SAE) that has a causal relationship with the investigational device, the comparator or the investigation procedure or where such causal relationship is reasonably possible.
- 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.
- Any new findings in relation to any event referred to in points (a) and (b).
Which investigations are subject to the safety reporting requirements?
Clinical investigations which require an application
Safety reporting is mandatory for all clinical investigations which require an application to NOMA.
Clinical investigations which require a notification
For PMCF investigations which require a notification to NOMA according to MDR article 74 (1), the reporting requirements are laid down in MDR Article 80 (5) and (6). This implies that the sponsor must report serious adverse events where a causal relationship between the event and the preceding investigational procedure has been established. Other incidents shall follow the provisions of vigilance laid down in MDR Articles 87-90, i.e. they follow the same reporting procedure as that of CE marked devices in normal use (cf. Serious Incidents and Field Safety Corrective Actions).
Clinical investigations that started under the directives (MDD/AIMDD)
The safety reporting requirements also applies to clinical investigations that started to be conducted in accordance with the medical device directives (MDD/AIMDD). Please cf. Clinical investigations started prior to 26th May 2021.
How to report?
Until EUDAMED is available, safety reporting must follow the current EU guideline, using the associated reporting form:
- MDCG 2020-10/1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745 and
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Appendix: Clinical investigation summary safety report form
The reporting form must be submitted by email to kki@noma.no. The subject heading should include "Safety reporting in clinical investigation" and NOMAs case reference number. The email must include the CIV-ID and title of the investigation, and information on the sponsor and contact person in case of follow-up questions.
Please note that the sponsor must report to all Member States in which the clinical investigation is being conducted, not only the Member State in which the event occured.
Definitions
Adverse event
MDR Article 2 (57):
Any untoward medical occurrence, 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 clinical investigation, whether or not related to the investigational device.
Serious adverse event
MDR Article 2 (58):
Adverse event that led to any of the following:
- death,
- serious deterioration in the health of the subject, 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
MDR Article 2 (59):
Any inadequacy in the identity, quality, durability, reliability, safety or performance of
an investigational device, including malfunction, use errors or inadequacy in information supplied by the manufacturer.