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Regulatory
MDCG revision 5 clarifies IVDR Rule 7 for control materials
Revision 5 updates the Rule 7 rationale and examples.
Event date
September 9, 2026
Source publication date
September 9, 2026
EU
Published non-binding guidance; no new statutory effective date inferred
Primary evidence → What it demonstrates → Evidence boundary → Practical implications → CFCM view.
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