Regulatory
Notified Body Scrutiny (IVDR Class D)
In one line
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.
Why it matters
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.
Common pitfalls
- •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.
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