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.
European Union
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
The documentation and evidence a complete submission is normally built from.
- 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
Planning ranges
Typical timeline and estimated cost
Ranges illustrate general market patterns for this pathway — they are not a quote for a specific product.
Estimated cost
$20k–$200k
Higher-risk classes with clinical performance studies carry substantially higher cost than the equivalent device class under the old IVDD.
Timelines and costs above are typical ranges illustrating general market patterns, not a quote or regulatory conclusion for your specific product. Actual figures depend on device classification, target country, and applicant readiness — professional review is required before relying on this for a business decision.
Where this applies
Applicable countries
Jurisdictions that recognise this certification. Scope and conditions still vary by product classification.
all EU/EEA member states
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.
View →
Reviewed packages
Buy a defined outcome
Pay for a market-access outcome — not a feature tour
Market Entry Sprint from $2,500 · Strategy Session $500 · Pathway Brief $1,800. Professional review required before business use. No patient data on public forms.
Reviewed launch planning
Need a IVDR pathway brief?
IVDR pathway briefs start at $1,800. Or book a $2,500 Market Entry Sprint that includes regulatory pathway outline, evidence flags, and a review call.
Professional review is required before business use.