OPERON ELEVATEPLUS | CE MARKING FOR MEDICAL DEVICES
Expert Medical Device CE Marking Consulting Services in the USA
Operon Strategist provides comprehensive CE marking consulting tailored to your device’s risk class. We support the full journey from classification and technical file preparation to conformity assessment, Notified Body engagement, and post-market requirements making your CE certification process efficient, streamlined, 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
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 CE Marking for medical devices?
CE Marking is a certification indicating that a medical device complies with the EU Medical Device Regulation (MDR 2017/745) or In Vitro Diagnostic Regulation (IVDR 2017/746), allowing it to be legally marketed and sold within the European Economic Area.
What is the difference between MDR and IVDR?
MDR (EU 2017/745) governs general medical devices, while IVDR (EU 2017/746) governs in vitro diagnostic devices; both set requirements for classification, technical documentation, clinical/performance evidence, and conformity assessment, but with device-specific rules.
How are medical devices classified under MDR?
Under MDR, devices are classified into Class I, IIa, IIb, or III based on risk level, intended use, duration of body contact, and invasiveness, with higher classes requiring more rigorous conformity assessment and Notified Body involvement.
What is a Notified Body and when is one required?
A Notified Body is an independent organization designated to assess conformity of medium- and high-risk devices (Class IIa and above); Class I devices (non-sterile, non-measuring) generally do not require Notified Body involvement.
Ready to Obtain CE Marking for Your Medical Device
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