Safety report

The procedures for safety reports are described in MDCG guidance 2020-10/1. The MDCG 2020-10/2 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.

No transitional arrangement has been established for safety reports of studies with a positive decision prior to 26 May 2022. This means that the safety reports of studies approved prior to 26 May 2022 must also fulfil the requirements of IVDR article 76. SAEs already reported do not need to be converted to the MDCG 2020-10/2 table. Exceptions are SAEs in studies that are just starting and SAEs with relevant new information on the notification. This concerns only 'reportable events' (see flow chart Adverse events in IVD performance studies). 
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!

• 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;
  • Studies with a positive decision prior to 26 May 2022;
  • Reporting is done using the MDCG 2020-10/2 table which is submitted via ToetsingOnline.

• 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 2020-10/2 table which is submitted through ToetsingOnline.

Definitions

SAE
SAE is the abbreviation for Serious Adverse Event. An SAE is an adverse medical event in a patient or study subject 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 ToetsingOnline. The review committee will receive a message that the safety information (SAE, line listing) has been uploaded and can start the assessment.

Adjustment to the procedure for reporting adverse events and IVD deficiencies

You are required to inform the MREC concerned of the new procedure for registering and reporting adverse events and IVD deficiencies. This can be achieved through an appendix to the protocol. You do not need to submit a separate substantial amendment. You must incorporate the changes regarding safety reports in the next substantial amendment of the research protocol.