EU Updates MDCG 2023-3 Guidance on MDR & IVDR Vigilance

The European Commission has published an updated version of the MDCG 2023-3 Rev.1 Questions and Answers on vigilance terms and concepts. This revised guidance provides essential clarifications for medical device and in vitro diagnostic medical device (IVD) manufacturers on regulatory vigilance requirements, expanding the scope to include the In Vitro Diagnostic Regulation (IVDR), alongside updates for the Medical Device Regulation (MDR).

Key Updates to Existing Guidance

This revision brings a series of significant changes:

• • Expanded Scope: IVDR has been integrated, complete with new examples and clarifications specific to IVDs.
  • Clarifications on Incident Reporting: A newly added table in Question 1 helps distinguish between an ‘incident’ and a ‘serious incident’.
  • Updated Reporting Flowchart: Revisions now incorporate terms and definitions relevant to IVDR, aiding in determining reportable events.
  • Manufacturer Awareness Date: Question 15 now includes additional explanation regarding the ‘manufacturer awareness date’.
  • Enhanced FSCA Guidance: Question 20 has been expanded to detail how Competent Authorities may coordinate assessments on serious Field Safety Corrective Actions (FSCAs).
  • Alternative Vigilance Data Exchange: New instructions are provided for data exchange when the EUDAMED system is temporarily unavailable, applicable once EUDAMED usage becomes mandatory.

New Questions Added

The update introduces several new questions:

• • Question 8: Covers indirect harm related to IVDs and addresses what constitutes “any harm as a consequence of a medical decision or action” under Article 2(67) of IVDR.
  • Question 9: Provides guidance on reporting expected erroneous results within the IVDR vigilance system.
  • Question 11: Clarifies whether serious incidents with CE-marked devices in clinical investigations require reporting.
  • Question 19: Outlines requirements for manufacturers to inform authorities of preventive or corrective actions as per MDR Article 83(4) and IVDR Article 78(4).

For more details, access the full document here: mdcg_2023-3_en.pdf

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