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
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 & HIPAA compliant security
92% Effective
Scientifically proven performance
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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| Quality Standards |
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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 0123
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.
Clinical Study Results
inne’s performance claims are backed by rigorous clinical studies conducted according to international standards.
92%
Clinical Effectiveness
Accuracy in detecting fertile window
~300
Study Participants
Diverse population sample
1,467
Test Cycles
Analyzed across multiple cycles
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.
- 99.6% hormone detection accuracy
- Consistent, reliable readings
- Validated testing protocol
Medical-Grade Safety
Designed and manufactured to the highest medical device standards with rigorous quality controls.
- Biocompatible materials
- ISO 13485 certified manufacturing
- Continuous quality monitoring
Science-Backed Decisions
Your fertility decisions guided by real hormone data, not just calendar predictions or algorithms.
- PdG hormone confirmation
- Individual cycle insights
- Evidence-based guidance
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
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.
