OPERON ELEVATEPLUS | CE MARKING FOR MEDICAL DEVICES
Medical Device CE Marking Consultant for EU MDR & IVDR
Operon Strategist provides comprehensive CE marking consulting tailored to your device’s risk class. We support everything from classification and technical file preparation to conformity assessment, Notified Body engagement, and post-market requirements, making your CE certification process efficient and compliant.
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Operon ElevatePlus
CE Marking for Medical Devices Service Portfolio
Device Classification & Regulatory Strategy
Determine the correct risk class (Class I, IIa, IIb, III under MDR or applicable IVDR categories)
Tailored CE compliance roadmap based on MDR (EU 2017/745) and IVDR (EU 2017/746)
Technical Documentation Preparation
Complete CE technical file with Essential Safety & Performance Requirements (GSPR)
Risk management documentation as per ISO 14971
Clinical Evaluation Report (CER) / Performance Evaluation Report (PER)
Labeling, Instructions for Use (IFU), UDI, and traceability documentation
Conformity Assessment & Notified Body Support
Notified Body identification, selection, and application management
Audit readiness planning and technical file review
Coordination with Notified Bodies for conformity assessment and certification
CE Marking for Software as a Medical Device (SaMD)
SaMD classification and qualification under MDR / IVDR (Rule 11 assessment)
Regulatory strategy for standalone software, AI/ML-based medical software
Preparation of SaMD technical documentation including software architecture, lifecycle, and validation
Compliance with IEC 62304, IEC 82304-1, IEC 62366, and cybersecurity requirements
Support for CE marking, Notified Body interactions, and certification of SaMD products
Quality Management System Integration
ISO 13485 implementation and alignment with MDR / IVDR requirements
QMS gap assessment and SOP documentation support
Integration of software lifecycle and risk management processes into QMS
European Authorized Representative (EC REP) Services
Operon Strategist acting as EC REP for non-EU manufacturers
Regulatory representation and liaison with EU Competent Authorities
Post-Market Compliance & PMS Support
Post-Market Surveillance (PMS) planning and implementation
Vigilance reporting, PMCF/PMPF, and incident management
Ongoing compliance support throughout the product lifecycle
CE Marking for SiMD/SaMD
SaMD qualification & MDR Rule 11 classification
CE regulatory strategy for software-based medical devices
Technical documentation tailored for software risk & cyber security compliance
Clinical evaluation & performance evidence planning
Notified Body coordination for SaMD certification
What Sets Us Apart
Global exposure, structured thinking, and execution-ready expertise
CE Marking Support Across Multiple Device Classes (Class I–III & IVDs)
Technical Documentation & Notified Body liaison Expertise
Regulatory Support in EU MDR & IVDR Frameworks
Presence in India, Germany, UK & Global Markets
Operon Design History File Advantage
Expert regulatory support to achieve CE compliance and place your medical device on the European market
End-to-End CE Marking Process Guidance
Device Classification & Risk-Based Conformity Support
Notified Body Selection & Auditing Support
European Authorized Representative Services Available
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frequently asked questions
What is the difference between EU MDR and IVDR?
EU MDR (Regulation 2017/745) governs general medical devices, while IVDR (Regulation 2017/746) governs in vitro diagnostic devices; both set requirements for classification, technical documentation, and conformity assessment before a device can carry the CE mark.
What technical documentation is needed for CE marking?
CE marking requires a complete technical file addressing Essential Safety and Performance Requirements, ISO 14971 risk management documentation, a Clinical or Performance Evaluation Report, and labelling, IFU, and UDI traceability records.
Does CE marking require a Notified Body for every device?
Notified Body involvement depends on device classification; higher-risk devices (Class IIa, IIb, and III under MDR, or higher-risk IVDs under IVDR) require Notified Body conformity assessment, while some lower-risk devices can self-certify.
What is CE marking under the EU MDR and IVDR?
CE marking is a conformity marking that indicates a medical device or in vitro diagnostic device meets the applicable requirements of European Union legislation, including the Medical Device Regulation (EU) 2017/745 (MDR) or In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR).
Ready to Obtain CE Marking for Your Medical Device
Connect with a CE Marking specialist at Operon