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 framework of clinical investigation under the MDR has different requirements for safety reporting.

For clinical investigations subject to MDR article 82, the rules of the Dutch Medical Research Involving Human Subjects Act [Wet medisch-wetenschappelijk onderzoek met mensen, WMO]  continue to apply for reporting safety reports (article 10, WMO).
The flow chart below can be used for registering and reporting adverse events and medical devices deficiencies during clinical investigations.

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

• Safety reports that must comply with MDR article 80 and MDCG 2020-10/1&2:
  • Clinical investigations in the context of conformity purposes (MDR article 62 or 74.2);
  • Post-market clinical follow-up investigations (MDR article 74.1) for SAEs related to the investigational procedure;
  • Studies with a positive decision prior to 26 May 2021 and an obligation to notify the IGJ/CCMO, with the exception of studies that are subject to MDR article 82;
  • Reporting is done using the MDCG 2020-10/2 table which is submitted via Research Portal.
• Safety reports that must comply with the vigilance provisions of MDR articles 87-90 and that fall under the manufacturer's responsibility:
  • Post-market clinical follow-up investigations (MDR Article 74.1) except SAEs related to the investigational procedure;
  • Reporting of SAEs related to the investigational procedure is done using the MDCG 2020-10/2 table which is submitted through Research Portal.
• Safety reports that must comply with article 10 of the WMO:
  • Other clinical investigations (MDR article 82);
  • Studies with a positive decision prior to 26 May 2021 and that are subject to MDR article 82;
  • Reporting is done using the SAE report form on Research Portal.

A sample form is available showcasing the questionnaire.

Attention: This form is only a sample template of the questionnaire that must be completed online. It cannot be filled out or submitted in this format.

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 MDR 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.

Device deficiency
The MDR 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 device 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.