EU Market Access for Medical Devices – MDR/IVDR Compliance Support

Achieving market access in the European Union requires meeting the stringent expectations of the EU Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746). Masuu Global Solutions simplifies this journey by guiding manufacturers through every stage of compliance—from Notified Body assessments and CE technical documentation to EUDAMED registration, labeling alignment, and lifecycle obligations.

We provide complete support for transition projects such as MDD → MDR and IVDD → IVDR, ensuring your device portfolio remains compliant under the new regulatory framework. We also offer full EU Authorized Representative (EAR) services and comprehensive CE certification support, allowing you to focus on innovation while we secure your regulatory success.

EU Medical Device Compliance Landscape

The EU represents one of the most regulated and commercially strategic medical device markets worldwide. Across 27 EU member states, 3 EEA countries, and Turkey, a harmonized regulatory system ensures consistent standards of device safety and clinical performance.

To legally sell a device in the EU, manufacturers must obtain CE marking, which validates conformity with MDR/IVDR based on the device’s risk class and conformity assessment route. Non compliance can result in:
  • Suspension or withdrawal of CE certificates
  • Product recall or border seizure
  • Market access restrictions
  • Delays or loss of certification

Key Requirements Under MDR/IVDR

  • CE marking is mandatory for all medical devices and IVDs
  • EUDAMED modules are being introduced in phases, with several already active
  • Non EU/EEA/Turkey manufacturers must appoint an EU Authorized Representative (EAR)
  • Stricter rules demand robust technical documentation, clinical/performance evidence, and continuous PMS

Masuu Global Solutions supports manufacturers through every step—from strategy and documentation to oversight and post market compliance—ensuring smooth and sustainable access to the entire EU/EEA region.

EU MDR/IVDR Step by Step Compliance Process

EU market entry includes clearly defined stages. Masuu manages the entire process on your behalf, including:
  • Risk classification
  • Conformity assessment planning
  • Technical documentation creation
  • Clinical/performance evaluations
  • Notified Body submissions
  • CE marking and EUDAMED registration
  • PMS/Vigilance activities

Typical timelines range from 3–12 months, depending on device class and documentation readiness.

Masuu’s Key MDR/IVDR Compliance Services

Regulatory Strategy & Transition Support

  • Customized MDR/IVDR strategies
  • Smooth transition from MDD/IVDD to MDR/IVDR
  • Roadmaps tailored to device type and business goals

Technical Documentation & Conformity Assessment

  • Development and review of Technical Files / Design Dossiers
  • Complete support for CE marking and NB submissions
  • Guidance on safety & performance testing and conformity pathways

Clinical & Performance Evaluation

We prepare all required clinical and performance evidence, including:
  • CERs & PERs
  • PMCF/PMPF plans
  • PSURs, PMSRs
  • Summaries of safety, performance, and biological evaluation content

UDI & EUDAMED Registration

  • UDI system compliance
  • EUDAMED registration and lifecycle data maintenance

EU Authorized Representative (EAR) Services

For non EU manufacturers, Masuu acts as your official EAR:
  • Device registration with local authorities
  • Maintenance of regulatory records and declarations
  • Oversight of compliance and CE documentation

Post Market Surveillance (PMS)

  • PMS plans and reports
  • Vigilance reporting
  • FSCA, FSN, and CAPA management
  • Ensuring continuous CE mark retention

CE Device Registration

  • End to end CE marking support
  • NB coordination and submission management
  • Approvals across all device and IVD categories

Quality Management System (QMS) Support

  • ISO 13485 implementation and maintenance
  • MDR/IVDR aligned QMS enhancements
  • Audit readiness support

Labeling & Artwork Compliance

  • MDR/IVDR labeling requirements
  • EU language and symbol compliance
  • IFU and packaging review

EU Authorized Representative (EAR) – Masuu’s Service Offering

EU Device Registration

As your EAR, Masuu manages device registration with relevant Competent Authorities and ensures compliance across all involved member states.

Documentation & Conformity Assurance

We ensure your:
  • Declaration of Conformity
  • CE certificates
  • Technical documentation

are complete, up to date, and compliant.

Communication With Authorities

We act as your direct representative for:
  • Competent Authority inquiries
  • Notified Body questions
  • Regulatory clarifications

ensuring clear, timely responses.

Vigilance & Incident Handling

We manage:
  • Incident notifications
  • FSCA coordination
  • FSN communication
  • Interactions with healthcare organizations & authorities

Audit & Inspection Readiness

We maintain all documentation and correspondence to support inspections, ensuring full MDR/IVDR alignment.

Why Partner With Masuu Global Solutions?

  • Full-spectrum regulatory expertise—from premarket submissions to post-market vigilance
  • 2000+ successful device registrations across diverse categories
  • Strong presence in the EU with an established EAR function
  • Strategic MDR/IVDR transition support for legacy and new devices
  • On-ground support through regional experts and global delivery teams
  • Track record of successful MDR/IVDR remediation and CE marking
  • Transparent communication and structured project governance
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