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MDCG Guidance: In-Vitro Diagnostic Medical Device Safety Reporting

The European Commission’s Medical Device Coordination Group (MDCG) released updated guidance "Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746 ". Under the In Vitro Diagnostic Medical Device Regulation (IVDR), sponsors must notify all member states of serious adverse events that have a causal relationship to the device, along with certain other safety findings.

The sponsor shall report without delay to all Member States in which a performance study is being conducted all of the following by means of the electronic system referred to in IVDR Article 69:

  1. 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

  2. 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

  3. any new findings in relation to any event referred to in points 1 and 2.

The period for reporting shall take account of the severity of the event. Where necessary to ensure timely reporting, the sponsor may submit an initial report that is incomplete followed up by a complete report.

This guidance has been developed by MDCG to interpret those requirements and covers topics such as the reporting method, timelines, and determining the causality. Sponsors must notify national authorities within two calendar days of the most serious events.

An adverse event can be categorized into four categories based on the assessments:

  1. not related,

  2. possible,

  3. probable, and

  4. causal relationship.

MDCG describes each group in detail, explaining that an IVD can be found to have a causal relationship to an adverse event if an error in use leads to harm to the patient. To have full insights on this guideline click this LINK.


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