Notified Body Scrutiny (IVDR Class D)
Additional expert-panel review of a notified body's assessment for certain novel or high-risk Class D devices before certification.
Definition
Article 48(6) requires the notified body assessing a Class D device to notify a designated expert panel of its Performance Evaluation Assessment Report (PEAR) where no CS exist for the device, the device is the first of its kind, or the CS have been recently revised. The expert panel may deliver a scientific view within 60 days that the notified body must duly consider.What this means in practice
Scrutiny is a checkpoint intended to raise consistency across notified bodies for the highest-risk IVDs (HIV, HCV, blood grouping, novel pathogen assays). It borrows the mechanism of MDR Article 54 CECP scrutiny for implantable Class III devices.Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsRegulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.
EU IVDR's risk-based classification: Class A (lowest) to Class D (highest).
EU-designated organization that assesses conformity of medical devices under MDR and IVDR.
More in Regulatory
· Same categoryFDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
Where this term appears across MedTech Terms.
Primary references
3 sources- 1
Regulation (EU) 2017/746, Article 48(6) and Article 106VerifiedEUR-Lexeur-lex.europa.eu
- 2
MDCG 2019-3 Interpretation of Article 54(2)(b) MDR (analogous)UncheckedMDCGhealth.ec.europa.eu
- 3
RAPS Regulatory FocusVerifiedRAPSraps.org
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