Bringing a medical device to the European Union market requires strict adherence to the EU Medical Device Regulation (EU MDR 2017/745). The regulation imposes stronger safety, performance, and post market requirements compared to the previous MDD framework.
Masuu Global Solutions provides comprehensive EU MDR compliance services, helping manufacturers navigate the regulatory changes efficiently and achieve timely certification under MDR.
EU MDR Compliance – Overview
- Expanded clinical evidence expectations
- Stricter safety and performance documentation
- Increased post market surveillance obligations
- New classification rules and conformity pathways
Devices previously certified under the MDD benefit from defined transition periods, allowing both MDR certified and legacy MDD certified devices to coexist temporarily in the European market.
Masuu Global Solutions supports manufacturers throughout this transition—ensuring MDR conformity, updating technical documentation, and coordinating with Notified Bodies to maintain uninterrupted market access.
Transition Timelines & Classification Changes
- Device classification rules (especially for software, reusable instruments, and certain higher risk categories)
- Clinical evaluation requirements
- Technical documentation structure
- Post market surveillance and vigilance expectations
Navigating these changes requires cross functional coordination, detailed regulatory interpretation, and robust planning. Masuu assists organizations in identifying required updates, performing gap assessments, and executing MDR transition activities with precision.
Masuu’s EU MDR Compliance Services
MDR Implementation Strategy
- Evaluating current QMS and documentation gaps
- Mapping required changes across departments
- Creating cross functional teams with clear responsibilities
- Resource planning and timeline management
- Integrating MDR with other global regulatory frameworks
- Determining new testing requirements imposed by MDR
- Coordinating expectations with your Notified Body
Gap Analysis — MDD to MDR
We perform detailed assessments comparing your current documentation, QMS, clinical data, labeling, and PMS processes against MDR requirements, identifying precise actions needed for compliance.
Clinical Evaluation Report (CER) Support
Masuu provides full CER development, including literature reviews, clinical data assessment, state of the art evaluation, and MDR aligned template creation.
Post Market Surveillance (PMSR, PSUR, SSCP)
- PMS Reports (PMSR)
- Periodic Safety Update Reports (PSUR)
- Summary of Safety and Clinical Performance (SSCP)
Regulatory Resource Augmentation
We provide onshore/offshore regulatory experts to supplement your team for MDR projects.
European Authorized Representative (EAR) Services
Masuu acts as your EAR for devices marketed in the EU, ensuring compliance with MDR obligations and regulatory communication.
MDR Submission Support
We assist with NB submissions, documentation updates, deficiency responses, and audit preparation.
Regulatory Intelligence
We track EU importation requirements, evolving MDR guidance, NB capacity updates, and other regulatory changes to support proactive decision making.
QMS Compliance & Mock Audits
- ISO 13485 compliance assessment
- MDR aligned QMS updates
- Internal audits and readiness checks
Document Management System for MDR
We help implement structured, audit ready document control systems to manage MDR related files, templates, and updates.
Device Classification & Reclassification
We review your product portfolio and determine correct MDR classification, including changes triggered by new MDR rules.
UDI Implementation
Masuu supports UDI strategy, labeling, data structuring, and EUDAMED readiness.
Risk Management (ISO 14971)
We help ensure your risk management files meet updated MDR expectations and integrate with CER and PMS activities.
Training & PRRC Services
- MDR training (online or in house)
- Assistance with Person Responsible for Regulatory Compliance (PRRC) role
- Identification of MDR Notified Bodies