MDCG revision 5 clarifies IVDR Rule 7 for control materials
Summary
Revision 5 updates the Rule 7 rationale and examples.
Source Date
September 9, 2026
Source checked
September 20, 2026
Event Type
guidance_update
Event Date
September 9, 2026
Geography
EU
Commercial Regulatory Status
Published non-binding guidance; no new statutory effective date inferred
Related CFCM Topics
/resources /market-intelligence
Category
Regulatory
Primary source
Read the source →Facts supported by cited sources
Revision 5 updates the Rule 7 rationale and examples.
For controls intended for IVD procedures, unassigned controls fall under Rule 7, class B unless other rules apply; manufacturer-assigned controls follow implementing rule 1.6.
Standalone QC materials do not replace mandatory controls for verifying the IVD itself.
Claims Requiring Caution
This guidance is non-binding; it does not automatically classify RUO products.
Intended purpose and the complete applicable rules determine classification.
Why It Matters
CFCM analysis: review control IFUs and distinguish assigned values from indicative ranges before assessing local implications.
An announcement is not proof of availability or authorisation. Interpret status within the stated jurisdiction and evidence boundary.
Editor and independence disclosure →