MDCG adds four questions to vigilance terms guidance to comply with MDR/IVDR

The European Commission’s Medical Device Working Group (MDCG) has revised its guidance on vigilance terms to clarify issues such as erroneous results, indirect harm from IVDs, and the need to report certain serious incidents and corrective actions.

MDCG published the revised guidance defining vigilance terms used in the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) on 11 November, adding four new questions and answers, as well as making editorial changes and clarifications throughout the document.

One of the major revisions is the addition of question 8, which addresses indirect harm related to the use of IVDs. It addressed what should be considered harm resulting from a faulty IVD diagnosis and how it should be reported in the IVDR vigilance system.

MDCG said such misdiagnoses should be considered harmful to a person’s health because of the consequences of a medical decision based on incorrect information from the IVD.

“In the majority of cases, IVDs will, due to their use on specimens, rather than directly on the human body, not lead to direct harm of a person’s health,” said the guidance. “These devices are more likely to lead to indirect patient harm, which is caused by a medical decision, action taken or lack thereof based on incorrect information or result(s) provided by the IVD.”

The newly added question 9 asks how “expected erroneous result” is defined and how such events should be reported to the IVDR vigilance system. MDCG said such results are defined as incorrect or information obtained from the IVD. The group also used synonyms such as inadequate, inaccurate, and imprecise results within the same context.

MCDG noted that expected erroneous results must be documented and quantified in the product information and the technical documentation. The group also added that the benefits of the test during normal use must also outweigh the potential for erroneous results.

“Erroneous results that are not documented and quantified in the product information and the technical documentation and hence fall outside the declared performance of the IVD, are to be handled like incidents,” the guidance stated. “If such incidents qualify as serious incidents within the meaning of Article 2(68) IVDR, they should be reported in accordance with Article 82(1) IVDR as individual serious incident reports (i.e. as individual Manufacturer Incident Reports (MIRs)).”

“If the manufacturer cannot demonstrate that a potentially serious incident is an expected erroneous result within the deadlines set out in Article 82(3) - (5) IVDR, it should be considered a serious incident, and a MIR should be submitted within the defined timelines,” it added.

The guidance further addressed whether it is necessary to report serious incidents with CE-marked devices used in a clinical investigation or performance study, and the answer is yes. In question 11, MDCG said that such CE-marked devices are subject to vigilance reporting requirements.

Finally, the guidance's question 19 was added to address whether manufacturers must inform competent authorities about their preventive and corrective actions. It explained that based on MDR/IVDR requirements if a manufacturer decides to implement a safety-related preventive or corrective action due to a serious incident or a field safety corrective action, it is required to report the actions to the competent authorities.

"This information must be provided using the relevant vigilance report(s), i.e., the MIR or field safety corrective action form," said MDCG. "In these reports, the manufacturer should provide a relevant description of the safety-related preventive or corrective action and the associated reference or case number."

MDCG guidance

MDCG adds four questions to vigilance terms guidance to comply with MDR/IVDR

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