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Safety report

Undesirable events, such as serious adverse events (SAEs), may occur during your IVD performance study. Also, a  deficiency of the IVD concerned may become apparent. These occurrences must be reported to the review committee in the form of safety reports.

The procedures for safety reports are described in MDCG guidance 2024-4. The MDCG 2024-4 safety report form has been developed for reporting to the relevant committees. Each performance study frame under the IVDR has different requirements for safety reporting.

The flow chart below can be used for registering and reporting adverse events and IVD deficiencies during performance studies.

Please note: The definitions of (serious) adverse events and IVD deficiency under IVDR and WMO are different!

Download flow chart Adverse events in IVD performance studies
  • Safety reports that must comply with IVDR article 76 and MDCG 2020-10/1&2:
    • Performance studies  within the scope of IVDR (article 58 or 70(2));
    • Post-market performance follow-up studies (PMPF, IVDR article 70(1)) for SAEs related to the study procedure;
    • Reporting is done using the MDCG 2024-4 table which is submitted via the Research Portal.
  • Safety reports that must comply with the vigilance provisions of IVDR articles 83-86 and that fall under the manufacturer's responsibility:
    • Post-market performance follow-up studies (IVDR Article 70(1)) except SAEs related to the study procedure;
    • Reporting of SAEs related to the study procedure is carried out using the MDCG 2024-4 table which is submitted through the Research Portal.

Definitions

SAE
SAE is the abbreviation for Serious Adverse Event. An SAE is an adverse medical event in a patient or research participant that does not necessarily have a causal relationship with the treatment. The IVDR uses the following definition:

Any 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.

IVD deficiency
The IVDR uses the following definition:

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.

The sponsor must report any deficiency in the IVD that could have led to a serious adverse event if appropriate action had not been taken, if it had not been intervened with, or if the conditions had been less favourable.

How to submit

Because Eudamed is not available as yet, the sponsor is required to upload the safety information through the Research Portal. The review committee will receive a message that the safety information (SAE, line listing) has been uploaded and can start the assessment.