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.Examples
- A diagnostic assay for a newly identified zoonotic pathogen, for which no harmonized standards or common specifications yet exist, would undergo notified body scrutiny.
- A device for screening blood donations for a highly variable virus, where the common specifications for detection methods have been updated to include advanced molecular techniques, would be subject to scrutiny.
- The first-ever IVD to use a novel biomarker for early detection of a severe chronic disease, even if common specifications for similar diseases exist, would typically face expert panel scrutiny due to its novelty.
- •A common misconception is that scrutiny implies the notified body's assessment is incomplete or incorrect, when in fact it is a standard procedural step for certain high-risk devices.
- •Manufacturers often assume that if their device is not 'novel' or 'first of its kind,' it will bypass scrutiny, but if no common specifications exist or they were recently revised, scrutiny may still apply.
- •Some believe that expert panel scrutiny is a final decision-making body, but its role is to provide a scientific view for the notified body to consider, not to approve or reject certification directly.
Frequently asked questions
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsMDR Article 54 procedure in which an independent expert panel reviews the notified body's clinical evaluation assessment for certain Class III and implantable Class IIb devices.
Regulation (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.
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Sources
3 sourcesEvery citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 1Regulation (EU) 2017/746, Article 48(6) and Article 106Tier 1 VerifiedEUR-Lexeur-lex.europa.eu
- 2MDCG 2019-3 Interpretation of Article 54(2)(b) MDR (analogous)Tier 2 UncheckedMDCGhealth.ec.europa.eu
- 3RAPS Regulatory FocusTier 4 VerifiedRAPSraps.org
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