The healthcare ecosystem in the European Union (EU) is rapidly evolving as medical technologies become more advanced, personalized, and interconnected. To successfully enter the EU market, manufacturers must demonstrate that their medical devices meet stringent regulatory and safety requirements—culminating in the achievement of CE marking.
Masuu Global Solutions provides comprehensive CE marking support, guiding manufacturers through classification, documentation, quality management, testing, and Notified Body (NB) interactions. With a strong track record of successful CE technical submissions, we help streamline the pathway to EU compliance.
CE Marking Services – Overview
Under the EU Medical Device Regulation (EU MDR 2017/745) and EU In Vitro Diagnostic Regulation (EU IVDR 2017/746), manufacturers must meet detailed safety, performance, and quality requirements before placing devices on the EU market.
Masuu Global Solutions partners with manufacturers to interpret regulatory requirements, build compliant documentation, and prepare complete CE submission packages—ensuring a smooth, efficient, and fully compliant certification process.
Process for CE Marking Registration for Medical Devices
Device Identification & Classification
Determining classification under MDR/IVDR (Annex VIII) and identifying whether Notified Body assessment is required.
QMS Establishment (ISO 13485:2016)
Implementing a compliant Quality Management System covering design, manufacturing, and post market activities.
Clinical & Performance Data Planning
Defining required studies, data generation activities, and evidence collection strategies.
Technical Documentation Compilation
Preparing a full Technical File / Design Dossier in accordance with MDR/IVDR requirements.
Notified Body Submission & Audit
Submitting documentation for NB review, addressing questions, and completing conformity assessments.
Declaration of Conformity (DoC)
Preparing the DoC after successful NB assessment to formally confirm regulatory compliance.
CE Mark Affixing & Distribution Readiness
Supporting documentation transfers to Authorized Representatives, distributors, importers, and Competent Authorities if requested.
Post Market Surveillance (PMS) Preparation
Developing PMS plans, PMCF/PMPF strategies, and other lifecycle compliance documentation.
How Prepared Are You for CE Certification?
Gaining CE certification can seem overwhelming due to multiple regulatory, technical, and documentation requirements.
Masuu Global Solutions makes the journey easier by offering expert guidance at every milestone—ensuring timely, predictable, and compliance driven CE submissions.
Masuu’s CE Marking Capabilities
Regulatory Strategy & Classification
- Device qualification and classification under MDR/IVDR
- Determination of NB involvement and conformity assessment routes
Quality Management System (QMS)
- QMS setup and implementation per ISO 13485:2016
- Audit preparation and compliance maintenance
Clinical & Performance Data Support
- Planning and executing required studies
- Evidence generation, analysis, and documentation
Technical File Compilation
- Comprehensive Technical File preparation (MDR/IVDR)
- CER/PER support, labeling review, GSPR checklists, risk documentation
Notified Body Coordination
- Submission management
- Interactions, clarification handling, and audit support
Declaration of Conformity (DoC)
- DoC drafting and compliance validation
- Post certification documentation support
Advantages of Partnering With Masuu
- Proven experience supporting all device classes—from Class I to Class III, including implants, IVDs, and SaMD
- Local affiliates to support authority expectations and language requirements
- Dedicated EU medical writers specializing in MDR/IVDR documentation
- Expertise across medical devices and diagnostics for accurate, tailored support
- Cost effective representation solutions (EAR, UKRP, CH REP)
- A strong European delivery base for faster turnaround times