[Emergo, UL] EU Update: Medical Device Regulator MDCG Releases New Guidance on Safety Reporting for IVD Clinical Performance Studies

On April 15, 2024, the Medical Device Coordination Group (MDCG) released a new guidance document; MDCG 2024-4 Safety Reporting in Clinical Performance Studies of in Vitro Diagnostic (IVD) under the EU IVD Regulation (2017/746, IVDR). The guidance provides an in-depth look at safety reporting requirements for IVD performance studies under the IVDR. It introduces a tabular performance study Summary Safety Reporting (SSR) form in a separate appendix (Excel spreadsheet, v1.0).

 

Currently, from the IVDR date of application on May 26, 2022, Serious Adverse Event (SAE) reporting will be sent to competent authorities of the member states (or submitted via national databases), until EUDAMED is fully functional. Once EUDAMED becomes fully functional and mandatory, the reporting will occur during the EUDAMED Module “Clinical Investigations and Performance Studies”, which will automatically notify the member state competent authorities electronically.

 

The reporting so far has been based on the guidelines published for clinical investigations, MDCG 2020-10/1 Rev.1 Guidance on Safety Reporting in Clinical Investigations and MDCG 2020-10/2 Rev. 1 Appendix: Clinical Investigation Summary Safety Report Form.

 

Performance studies and report types

MDCG 2024-4 outlines the types of clinical performance studies subject to safety reporting and the types of reports to be submitted. Notably, there are cases where a clinical performance study SSR form and a Manufacturer Incident Report (MIR) are required.

 

Here, MDCG 2024-4 clarifies that in addition to the adverse event reporting obligations of the study sponsor per IVDR Article 76 for adverse events that occur during performance studies, the device manufacturer is responsible for post-market surveillance and vigilance obligations for the CE Mark device per IVDR Articles 82-83. This requires adequate QMS procedures for vigilance reporting to meet the obligations from IVDR Article 10(8) k and 10(12).

 

The guidance clarifies that any clinical performance study or post-market performance follow-up (PMPF) study requires the active involvement of the device manufacturer next to the study sponsor to cover not only vigilance reporting for all occurring scenarios inside the clinical performance study (or PMPF study), but also vigilance scenarios affecting the manufacturer’s devices placed on the market (if CE-marked).

 

 

EU Update: Medical Device Regulator MDCG Releases New Guidance on Safety Reporting for IVD Clinical Performance Studies | Emergo by UL

EU Update: Medical Device Regulator MDCG Releases New Guidance on Safety Reporting for IVD Clinical Performance Studies

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