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Understanding the New MDCG 2024-4 Guideline for IVD Safety Reporting

On April 15th, 2024, the Medical Device Coordination Group (MDCG) issued guideline MDCG 2024-4 for In Vitro Diagnostic (IVD) devices. Prior to the release of this document, safety events were reported per established guidelines for clinical investigations, specifically MDCG 2020-10/1 and MDCG 2020-10/2, often with input from relevant ethics committees. The MDCG 2024-4 guideline clarifies safety reporting, aligning with Article 76 of the IVDR.

MDCG 2024-4 emphasizes reporting requirements for interventional, burdensome, and risky studies, including those involving companion diagnostics. However, for Post-Market Performance Follow-up (PMPF) studies, this guideline is only relevant when reporting Serious Adverse Events (SAEs) with a causal link to the previous PMPF study.

In summary, the guideline outlines reportable events that must be promptly submitted to all Member States where the study is approved. These events include any:

  1. 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. 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. New findings in relation to any event referred to in points a) and b)

The new MDCG 2024-4 provides clear definitions for relevant terminology related to clinical performance studies and IVDs, which is essential for appropriate reporting of the events. It also specifies that when assessing the causal relationship of an event, it applies not only to the investigational device but also to the sample collection procedure and any ancillary IVD device used in the study. For example, SAEs related to CE-marked comparator IVDs or other on-market IVDs used during the study procedure should not only be reported but also followed-up on by the study Sponsor. It is important to note that the relatedness of an SAE to the procedure and the device must be assessed independently, although they are not mutually exclusive. Additionally, the intended user of the device can impact the causality assessment. A healthcare provider’s assessment carries more weight for Point-of-Care and Laboratory-based tests, while self-tests require equally relevant assessments from both users and Sponsors.

Reporting safety events to the Member States is a crucial aspect of any clinical investigation. While awaiting the full launch of EUDAMED, the MDCG 2024-4 offers a ‘Performance Study Summary Safety Reporting Form’ in its Appendix, allowing submission of all reportable events to the Member States until EUDAMED becomes fully operational.


NAMSA Expert Insight

The recent release of MDCG 2024-4 marks a significant stride toward harmonizing safety reporting processes for IVD devices. As the healthcare landscape evolves, ensuring robust safety protocols becomes paramount.

While implementing correct safety reporting involves intensive data collection and adaptation of stakeholders’ procedures to meet the guideline’s requirements, the benefits far outweigh the efforts. By standardizing the safety reporting process and reducing ambiguity, timely corrective actions can be taken. Notified Bodies can assess compliance for efficiently, leading to improved data quality and better risk identification for users and patients.

NAMSA’s experience reinforces my belief that this guideline will positively impact patient safety and streamline regulatory compliance. As manufacturers, Sponsors, and regulators collaborate to implement MDCG 2024-4, patient well-being remains at the heart of our collective efforts.


Why Partner with NAMSA?

As a leading medical device and in vitro diagnostic CRO, NAMSA brings exceptional expertise to safety reporting in IVD studies according to MDCG 2024-4. Our regulatory, clinical, and safety consultants provide precise guidance, tailored solutions, timely vigilance and reporting, and unwavering quality assurance. By partnering with us, you can navigate safety complexities confidently, ensuring patient safety and regulatory compliance.

Lucia Garcia Inciarte, MsC, MBA

Lucia has been in the industry over 12 years with 4 years focused on medical devices specifically in In vitro diagnostic devices, and medical devices mainly within the cardiology, vascular, infectious diseases therapeutic areas. She has broad experience in a variety of roles both in research and industry, including Clinical Operations Manager, Clinical Research Scientist and Project Leader. Lucia is an expert in Clinical Investigations, including the design, management and execution of studies from start-up to clinical study report for medical devices in every stage of their life cycle. Lately, Lucia has worked in first-in-human and feasibility studies for heart failure implantable devices, clinical performance studies and usability studies for infectious diseases IVDs and a post-market clinical follow up study for a vascular medical device. Throughout her career in clinical research, Lucia has developed notable experience in Good Clinical Practice, European Regulations, EU’s Global Data Protection Regulation (GDPR), ISO14155:2020 and ISO20916:2019.