OPERON ELEVATEPLUS | CE MARKING FOR MEDICAL DEVICES
CE Marking & EU MDR Certification for Medical Devices
As your dedicated CE marking consultant in Germany, Operon Strategist provides comprehensive CE marking for medical devices, strictly tailored to your product’s specific risk class. We support every phase of the regulatory lifecycle—from EU MDR classification and Technical Documentation preparation to Notified Body conformity assessments and mandatory EUDAMED post-market requirements—making your CE certification process highly efficient, predictable, and fully 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
EU MDR CE Marking & Compliance – We support medical device manufacturers in achieving rapid CE Mark certification through a structured, risk-based approach aligned with the latest European regulations. Our specialized services include device classification, Clinical Evaluation Report (CER) development, dedicated EC REP services, and end-to-end Notified Body audit support, enabling your business to execute a confident and secure entry into the German and broader European 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
