CE Marking (Medical Devices)
The conformity mark required to sell medical devices in the EU/EEA, issued once a device meets EU MDR or IVDR requirements.
Overview
What CE Mark is and why it matters
CE Marking is the visible symbol confirming a medical device meets the applicable EU regulation — the Medical Device Regulation (MDR) 2017/745 for devices, or the In Vitro Diagnostic Regulation (IVDR) 2017/746 for diagnostics. It is not itself a regulation — it is the mark a manufacturer is authorized to apply once the underlying regulatory requirements are satisfied.
Requirements
What you'll need
- Device classification under MDR Annex VIII (Class I, IIa, IIb, III)
- Quality management system certified to ISO 13485
- Technical documentation per MDR Annex II/III
- Clinical evaluation report
- Notified Body conformity assessment (Class IIa and above)
- EU Authorized Representative appointed (non-EU manufacturers)
- UDI assignment and EUDAMED registration
- Post-market surveillance and vigilance system
Typical timeline
6–18 months
Self-certified Class I devices can move in ~2–3 months; Class IIb/III requiring Notified Body review commonly take 12–18 months given current Notified Body capacity.
Estimated cost
$15k–$150k
Class I self-declared devices may stay under $10k in consulting/documentation; Class III devices with full Notified Body review and clinical data commonly exceed $100k.
Where this applies
Applicable countries
Related
Regulatory Pathways
FAQ
Frequently asked questions
Is CE Marking the same as MDR certification?+
CE Marking is the visible mark; MDR (or IVDR for diagnostics) is the regulation that defines what a device must satisfy to earn it.
Do all devices need a Notified Body?+
No — most Class I devices without a measuring function or sterile packaging can be self-certified. Class IIa and above generally require Notified Body involvement.
Is the old Medical Device Directive (MDD) still valid?+
The MDD has been replaced by the MDR, which became fully applicable in 2021, with extended transition periods for certain legacy devices.
Related
Related Certifications
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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UKCA
The UK's post-Brexit conformity mark for the Great Britain market, overseen by the MHRA.
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Reviewed launch planning
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CE Mark pathway briefs start at $1,800. Or book a $2,500 Market Entry Sprint that includes regulatory pathway outline, partner shortlist, and a review call. Professional review required before business use.
Professional review remains part of the workflow.
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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.