The MDCG Group (Medical Device Coordination Group) just released a revised version of MDCG 2023-3. This guidance document provides answers to different questions concerning vigilance terms and concepts according to Regulation (EU) 2017/745 and Regulation (EU) 2017/746 (MDR and IVDR). Contrary to the first release, the new version covers both MDR and IVDR, whereas this first version only included medical devices regulated by the MDR.
Vigilance terms as outlined in the IVDR
Among the additions, the guidance now includes the definitions of “incident” and “serious incident” also for the IVDR:
Similarly, Q3 includes a clarification on “malfunction or deterioration in the characteristics or performance of a device” according to Article 2(67) IVDR. In this sense, the document now specifies that “for IVDs, the performance of a device (Article 2.39 IVDR) consists of the analytical and, where applicable, the clinical performance supporting its intended purpose. This device performance must be substantiated by the manufacturer in the technical documentation.”
Reporting of serious incidents and preventive or corrective actions
In the new revision, MDGC 2023-3 includes some new questions on vigilance of both medical devices and IVDs. Among the new questions, Q11 addresses the reporting of serious incidents with CE- marked devices used in a clinical investigation or performance study. The reply specifies that CE-marked devices used in clinical investigations or performance studies are subject to the vigilance reporting requirements.
On the other hand, Q19 clarifies the proactivity expected from manufacturers when it comes to preventive or corrective actions. In this context, the guidance document clarifies that if a manufacturer identifies a need for a safety-related preventive or corrective action linked to a serious incident or a field safety corrective action, the manufacturer must report this information to the competent authorities.
Check our Library of Documents for more guidance documents.
Do you have any questions on vigilance or incidents’ reporting? Contact us here or send an email to mdlaw@obelis.net.
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