New European MDCG Guidance on Medical Device Vigilance Requirements

By Elizabeth Pugh and Amelia Boldrick

The long-awaited Medical Device Coordination Group (MDCG) Guidance on Vigilance has been published to the European Commission website. MDCG 2023-3, Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices, provides additional information on key vigilance terms. Interestingly, the guidance only covers devices under the scope of the Medical Devices Regulation (MDR) and not those under the scope of the In Vitro Diagnostic Medical Devices Regulation (IVDR).

The guidance clarifies key differences in vigilance reporting between MEDDEV 2.12/1 rev.8 and the Regulations:

• The guidance features a flowchart that illustrates the process of analyzing complaints to determine reportability under the MDR.
• The difference between the term “incident” and the new term “serious incident” introduced in the Regulation are also discussed in detail.
• The deadline for reporting serious incidents not constituting serious public health threats, deaths or unanticipated serious deteriorations in state of health was reduced to 15 calendar days. The reporting period begins on the day after the awareness date of a serious incident.
• The awareness date may change if, during the investigation of an incident, the manufacturer receives additional information which subsequently changes the determination of the report to a serious incident. Although the original awareness date in section 1.2c of the manufacturer incident report (MIR) should still be identified, an explanatory comment may be placed within section 5 of the MIR.
• It can be challenging to understand when the MIR report type, Final (non-reportable), may be used. The guidance describes the two main situations appropriate for its use:
  • After submitting an MIR, further investigation of the incident and device involved reveals that the criteria for a serious incident were not fulfilled.
  • The manufacturer receives a user report of a potentially serious incident from a competent authority but establishes that the criteria for a serious incident are not met.

In such cases the manufacturer may submit a final MIR selecting this report type, also providing a rationale for its conclusion in section 4.2b.

• The terms “ergonomic features” and “use-errors due to ergonomic features” are defined and clarified.

We’re looking forward to the MDCG Guidance on IVDR vigilance as well as updated vigilance forms – especially the outdated field safety corrective action (FSCA) form.

Emergo by UL recently contacted the competent authorities in Switzerland and Liechtenstein for clarification on vigilance requirements for serious incidents and FSCAs occurring in Liechtenstein following the publication of updated requirements on their respective websites. Our representation clients are encouraged to contact the Emergo Global Vigilance team for information regarding reporting of vigilance for Liechtenstein.

The Emergo Global Vigilance team has extensive expertise and can assist clients with multi-market vigilance projects.