February 20, 2023

Recall Classification: EU MDR / IVDR

Neither the EU MDR nor IVDR contain a formal risk-classification scheme for recalls. So in general, other jurisdictions’ (e.g., U.S. FDA, Health Canada) defined recall classification tiers are not a clear paradigm of the EU MDR/IVDR (yet the future finalization of the EUDAMED database might change this).  The EU MDR/IVDR are however much like the U.S. FDA and Health Canada in that a risk-based approach is still certainly required for planning and implementing a recall (e.g., to assure proper recall depth and effectiveness); for resolving the issues that caused the recall; for writing the FSN or other advisory notice, etc.

Also of note is that there are various qualitative categorizations for EU MDR/IVDR remedial actions.  Specifically, the EU MDR/IVDR provide for actions such as, but not necessarily limited to, Non-FSCA Withdrawal, Non-FSCA Recall, FSCA Withdrawal, and FSCA Recall.  Be sure your EU MDR/IVDR procedures clearly address these various jurisdictional permutations.  This is important not only for assuring proper EU remedial action categorization, but also, for example, regarding the U.S. FDA’s comparatively differing definitions/thresholds of the same or similar terms (e.g., “Recall” and “Market Withdrawal”), which aren’t necessarily the same things as the EU’s definitions of “Recall”, “Withdrawal”, “FSCA”, etc.

Finally, when a Union Competent Authority (CA) becomes involved in an FSCA, the CA will assess the risk of the situation.  Some CA’s might have their own operational risk-classification scheme for grading the FSCA.  But in alignment with what I mentioned before, such classification (if any) isn’t legislatively prescribed by the EU MDR or IVDR.