IVDR (In Vitro Diagnostic Regulation)
The EU regulation governing in vitro diagnostic devices — the IVD counterpart to the MDR.
Overview
What IVDR is and why it matters
Regulation (EU) 2017/746 governs in vitro diagnostic medical devices in the EU/EEA. It introduced a risk-based classification system (Class A–D) and dramatically expanded the share of IVDs requiring Notified Body involvement compared to the prior IVD Directive.
Requirements
What you'll need
- Risk-based classification (Class A–D)
- Notified Body involvement for most Class B–D devices
- Performance evaluation covering analytical and clinical performance
- Technical documentation
- Quality management system per ISO 13485
- EUDAMED registration
Typical timeline
6–24 months
Class D IVDs (highest risk, e.g. blood-screening tests) face the most Notified Body scrutiny and the longest timelines.
Estimated cost
$20k–$200k
Higher-risk classes with clinical performance studies carry substantially higher cost than the equivalent device class under the old IVDD.
Where this applies
Applicable countries
Related
Regulatory Pathways
FAQ
Frequently asked questions
Why did my IVD suddenly need a Notified Body?+
IVDR moved roughly 80% of IVDs into categories requiring Notified Body review, versus roughly 20% under the previous IVDD — many previously self-certified products are newly in scope.
Related
Related Certifications
CE Mark
The conformity mark required to sell medical devices in the EU/EEA, issued once a device meets EU MDR or IVDR requirements.
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EU MDR
The EU regulation that defines medical device requirements — CE Marking is the certification mark it produces once satisfied.
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ISO 13485
The international quality management system standard specific to medical device manufacturers, referenced by most major regulators.
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Reviewed launch planning
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