Conformité Européenne
inne carries the CE mark, confirming compliance with EU regulations for quality, safety, and medical performance.
Medically Certified
CE-certified saliva-based contraception
92% effectiveness with typical use
Results from a clinical study; residual risk cannot be excluded.
What CE Certification Means
CE marking indicates that a medical device meets essential safety and performance requirements. For Inne, this means rigorous clinical testing and continuous monitoring of our manufacturing processes.
Safety First
Meets EU health & safety standards
Clinical Validity
Results verified by medical experts
Data Privacy
GDPR compliant security
92% Effective
Results from a clinical study; residual risk cannot be excluded.
EU-VERIFIED MEDICAL STANDARD
Certified under strict European medical regulations
inne is certified under the EU’s IVDR framework, ensuring it meets the highest standards for medical safety, accuracy, and reliability.
EU & UK
Officially approved for use across the EU and UK, meeting all regional medical device standards.
IVDR regulatory
Complies with the EU’s In Vitro Diagnostic Regulation (IVDR 2017/746), ensuring proven scientific accuracy and reliability.
CE-Certified vs Non-Certified Apps
Why clinical certification matters for your contraception
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| Clinical Validation |
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| Independent Audits |
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| Post-Market Monitoring |
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| Quality Standards |
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| Safety Testing |
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| Regulatory Oversight |
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CE-certified (IVDR)
Free shipping
Free support calls
30-day satisfaction guarantee
CE-certified (IVDR)
Free shipping
Free support calls
30-day satisfaction guarantee
Regulatory Approvals & Documentation
inne is certified for use in multiple regions, with full regulatory documentation available for transparency.
Market Approvals
European Union (CE Mark)
United Kingdom
Switzerland
Norway
Official Documentation
Clinical Study Results
inne’s performance claims are backed by rigorous clinical studies conducted according to international standards.
92%
Clinical Effectiveness
Results from a clinical study; residual risk cannot be excluded.
300
Study Participants
Diverse population sample
1,467
Test Cycles
Analyzed across multiple cycles
First Shipment
First Delivery
Starter Package
Your First Box
inne Minilab
- inne Reader with manual & charger
- inne Strips for 3 cycles
- inne Reader with manual & charger
- inne Strips to begin testing
- inne Reader guide & charging device
- inne strips for 3 cycles
- inne Reader manual & charger
- 3 cycles worth of inne strips
- Includes inne Reader instructions & charger
- Strips for 3 full cycles
Refill Shipments
Recurring Delivery
Ongoing Shipments
Refill Service
Strip Refills
- inne Strips for 3 cycles
- Convenient quarterly home delivery
- inne Strips for 1 or 3 cycles
- free delivery every 1 or 3 months
- inne strips for 3 cycles
- Delivered to your home every 3 months
- inne strips for 3 cycles included
- Automatic delivery every quarter
- 3 cycles of inne strips per shipment
- Quarterly delivery to your address
After your selected minimum term you can cancel monthly, otherwise the subscription is automatically renewed. Prices incl. VAT and shipping. Delivery time: 2-3 days.
MONEY-BACK GUARANTEE
4.7/5
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4.3/5
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4.6/5
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4.3/5
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4.6/5
Trustpilot
4.3/5
App Store
4.7/5
Play Store
4.6/5
4.3/5
Trustpilot
4.7/5
App Store
4.6/5
Play Store
inne Minilab
Save by paying upfront for your inne Strips or choose monthly billing. Your inne Strips are delivered quarterly (upfront payment) or monthly (monthly billing).
inne Reader +
Strip Subscription
Strip Subscription
€99
one-time payment
Includes:
- inne Reader
- inne Strips
- App access
Billed upfront
FREE READER €99— BEST VALUE
Your Order Summary:
inne Reader
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—Strip plan
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Shipping
FREE
Total Due Today:
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Total (Incl. Taxes):
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Free Inne Journal, only available for a limited time!
First Shipment
inne Minilab
Refill Shipments
Strip Refills
After your selected minimum term you can cancel monthly, otherwise the subscription is automatically renewed. Prices incl. VAT and shipping. Delivery time: 2-3 days.
Your subscription renews automatically after the term, but can then be cancelled monthly at any time. All prices include VAT & shipping. Delivery in 2-3 days.
After the term, you can cancel monthly – no hidden fees. Prices include VAT & shipping. Delivery: 2-3 days.
Flexible cancellation after the term, full cost control. All prices include VAT & shipping. Ready to ship in 2-3 days.
After your selected minimum term you can cancel monthly, otherwise the subscription is automatically renewed. Prices incl. VAT and shipping. Delivery time: 2-3 days.
Your subscription renews automatically after the term, but can then be cancelled monthly at any time. All prices include VAT & shipping. Delivery in 2-3 days.
After the term, you can cancel monthly – no hidden fees. Prices include VAT & shipping. Delivery: 2-3 days.
Flexible cancellation after the term, full cost control. All prices include VAT & shipping. Ready to ship in 2-3 days.
IVDR COMPLIANCE DETAILS
IVDR Compliance (EU 2017/746)
inne is certified under the EU's In Vitro Diagnostic Regulation (IVDR) 2017/746, which replaced the previous IVD Directive in May 2022. This represents the most stringent regulatory framework for diagnostic devices globally.
1
Technical Documentation
Complete product dossier including design, manufacturing, and risk assessment documentation.
2
Clinical Performance Evaluation
Scientific evidence demonstrating safety and performance through clinical studies and literature.
3
Notified Body Assessment
Independent audit by BSI verifying compliance with all regulatory requirements.
4
Post-Market Surveillance
Ongoing monitoring of device performance, safety reporting, and regular compliance audits.
BSI Notified Body
Certification Body 2797
BSI is the business improvement and standards company that enables organizations to turn standards of best practice into habits of excellence. As our Notified Body, they independently verify our compliance with European Medical Device regulations.
What This Means For You
Certification isn't just paperwork it translates directly into benefits that make a real difference in your daily life and health decisions.
Trusted Results
Every insight is backed by clinically validated testing methods and independently verified accuracy.
- High detection accuracy of hormonal changes
- Consistent, reliable readings
- Validated testing protocol
Medical-Grade Safety
Designed and manufactured to the highest medical device standards with rigorous quality controls.
- ISO 13485 certified manufacturing
- Continuous quality monitoring
Science-Backed Decisions
Your fertility decisions guided by real hormone data, not just calendar predictions or algorithms.
- Progesterone hormone confirmation
- Individual cycle insights
- Evidence-based guidance
Quality & Safety Standards
Our commitment to excellence through comprehensive quality management.
ISO 13485
Medical device quality management system certification.
IVDR 2017/746
Full compliance with In Vitro Diagnostic Regulation.
GDPR Compliant
Strict data protection and privacy standards.
Post-Market
Continuous monitoring and vigilance reporting.
