CE Marking Services
Streamlined pathway to CE certification for medical devices, ensuring compliance with EU regulations and market access.
What is CE Marking?
CE marking is a mandatory conformity marking for products placed on the European Economic Area (EEA) market. For medical devices, it indicates compliance with the essential requirements of the EU Medical Device Regulation (MDR) 2017/745, allowing manufacturers to legally market their devices throughout the EU.
Our CE marking services guide you through every step of the certification process, from initial assessment to successful market entry, ensuring full compliance with all applicable EU regulations.
Key Benefits of CE Marking
- Access to the entire EU and EEA market of over 500 million consumers
- Demonstrated compliance with rigorous EU safety and performance standards
- Enhanced product credibility and market acceptance
- Facilitated trade with simplified customs procedures
Our CE Marking Process
A structured approach to successful CE certification
Device Classification
Determine the correct classification of your medical device according to EU MDR guidelines, which dictates the appropriate conformity assessment route.
Technical Documentation
Preparation and review of comprehensive technical files including design dossiers, risk assessments, and clinical evaluation reports.
Conformity Assessment
Coordination with notified bodies for the required conformity assessment procedures based on your device classification and risk level.
Declaration of Conformity
Preparation and signing of the EU Declaration of Conformity, a legal document asserting compliance with all applicable requirements.
CE Mark Application
Proper application of the CE mark to your device and packaging, ensuring compliance with specific labeling requirements.
Post-Certification Support
Ongoing support for maintaining CE marking through post-market surveillance, documentation updates, and regulatory changes.
CE Marking by Device Category
Specialized expertise across all medical device categories
IVD Medical Devices
Specialized support for In Vitro Diagnostic devices navigating the IVDR (In Vitro Diagnostic Regulation) requirements for CE marking.
- IVDR-specific classification and conformity assessment
- Performance evaluation report preparation
- IVDR technical documentation development
Active Medical Devices
Comprehensive support for active medical devices, including software as a medical device (SaMD) and active implantable devices.
- Software validation and verification support
- Electrical safety and performance testing guidance
- Specialized documentation for active technologies
Implantable Devices
Expert guidance for implantable medical devices requiring the most rigorous conformity assessment under EU MDR.
- Advanced clinical evaluation support
- Long-term performance data requirements
- Specialized post-market surveillance planning
Class I Devices
Efficient certification support for low-risk Class I devices, including self-certification pathways where applicable.
- Simplified technical documentation
- Self-certification process guidance
- Special requirements for sterile Class I devices
Why Choose Our CE Marking Services
Proven expertise in navigating EU medical device regulations
Notified Body Relationships
Established relationships with leading notified bodies to streamline the conformity assessment process and reduce delays.
MDR & IVDR Expertise
Deep understanding of current regulations and practical experience with successful CE certifications under MDR and IVDR.
End-to-End Support
Comprehensive assistance from initial assessment through post-market surveillance, ensuring long-term compliance.
Time and Cost Efficiency
Proven methodologies to minimize certification timelines and avoid costly delays and rework.
Ready to Obtain CE Marking?
Our experts will guide you through the entire CE certification process, ensuring compliance with EU regulations and accelerating your market access.
Start Your CE Certification Journey