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Recently, the Medical Device Coordination Group (MDCG) published a guidance document outlining the procedures involved in the safety reporting of performance studies of in vitro diagnostic medical devices (IVDs). The safety reporting requirements are listed in  Article 76(2) of the Regulation (EU) 2017/746 – In Vitro Diagnostic Medical Device Regulation (IVDR). Access the main guidance document by clicking here. 

 

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 a) and b). 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. 

 

Upon request by any Member State in which the performance study is being conducted, the sponsor shall provide all information referred to in paragraph 1 of IVDR Article 76(1).

 

For post-market performance follow-up (PMPF) studies of CE-marked devices used within the intended purpose covered by the CE marking, reporting requirements of IVDR Articles 76(5-6) apply. This means that the vigilance provisions laid down in IVDR Articles 82 to 85 and in the acts adopted pursuant to IVDR Article 86 apply to PMPF studies.

 

However, this guidance document is still relevant for PMPF studies as the reporting of serious adverse events (SAEs) where a causal relationship to the preceding PMPF study has been established follow the reporting procedures of performance studies as outlined in IVDR Article 76.

 

Since the electronic system referred to in IVDR Article 69 (Eudamed and its module for clinical investigations and performance studies) is not yet available and fully functional from the date of application of the IVDR, this guidance outlines the procedures for safety reporting in performance studies in the absence of the Eudamed module or when Eudamed is not yet fully functional.

 

Key Points from MDCG 2024-4 Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746:

 

• The purpose of this document is to provide guidance and guidelines for safety reporting in performance studies of in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746.
• It outlines the requirements for reporting serious adverse events, device deficiencies, and new findings in relation to these events.
• The document also provides information on the reporting method, transition to reporting via Eudamed, and the reporting obligations of sponsors and investigators.
• Additionally, it defines various terms and abbreviations related to safety reporting in performance studies of IVDs.
• The document also includes a template for the completion of a Performance Study Summary Safety Reporting Form, which is used to report and track reportable events, serious adverse events (SAEs), and device deficiencies in a performance study of IVDs.
• The form ensures standardised reporting and facilitates the analysis of safety data in the performance study.

 

 

Manufacturers of IVDs should keep the following points in mind with this update:

1. Reporting Timelines: Manufacturers must be aware of the reporting timelines for reportable events and serious adverse events (SAEs). [Section 9 of the document]
2. Causality Assessment: Manufacturers need to conduct a thorough causality assessment to determine the relationship between the use of the IVD and the occurrence of each SAE. [Section 10 of the document]
3. Categorisation of Causality: Manufacturers should use the provided definitions to categorise the relationship between the SAE and the IVD.
4. Completion of Reporting Form: Manufacturers should use the provided Performance Study Summary Safety Reporting Form to report and track reportable events, SAEs, and device deficiencies. [Section 13 of the document]
5. Compliance with Eudamed: Until the Eudamed system is fully functional, manufacturers should use tracking numbers (CIV-ID) provided by the NCAs upon registration in the Eudamed2 database. [Section 11 of the document]
6. Use of Preferred Terminology: Manufacturers should use the preferred terminology and codes provided in the document for device issues, clinical signs/symptoms, and clinical impact.
7. Ongoing Assessment and Updates: Manufacturers should continuously assess and update the reported events as new information becomes available. [Section 11 of the document]
8. Compliance with Regulations: Manufacturers should ensure that their safety reporting practices align with the requirements outlined in Regulation (EU) 2017/746 and other relevant directives and decisions mentioned in the document.
9. Safety Reporting Obligations: Manufacturers should be aware of their safety reporting obligations as outlined in Article 76 of Regulation (EU) 2017/746 (IVDR).
10. Timely Reporting: Manufacturers should ensure that they report the relevant events without delay to all Member States where the performance study is being conducted.
11. Transition to Eudamed: Manufacturers should be aware that once Eudamed is fully functional, the reporting obligations and requirements will be applicable via Eudamed. [Section 5 of the document]
12. Compliance with Vigilance Provisions: Manufacturers should understand that for post-market performance follow-up (PMPF) studies of CE-marked devices, the vigilance provisions laid down in IVDR Articles 82 to 85 apply.

These guidelines could be overwhelming to follow, and that’s where our expertise comes into play!

Reach out to our experts by sending an email – mdd@mddltd.com or submitting a web form - https://med-di-dia.com/contact.php

 

At Med-Di-Dia, we can support you at every stage of your product development, this includes:

• Regulatory Strategy for Market Entry
• Quality Management Systems
• Representation in International Locations
• Local Representations
•  Post-market Surveillance
• Regulatory Risk Management
• Ad-Hoc Regulatory Support

Reach out to our experts by sending an email – mdd@mddltd.com or submitting a web form - https://med-di-dia.com/contact.php