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
Frequently Asked Questions
EU MDR compliance requires manufacturers to address device classification, clinical evaluation, technical documentation, risk management, quality management, labeling, UDI, conformity assessment, and post-market surveillance. The applicable requirements depend on the device and its risk classification. Manufacturers must demonstrate conformity before placing devices on the EU market and maintain compliance throughout the product lifecycle.
Transitioning from MDD to MDR requires manufacturers to compare existing documentation and processes against current MDR requirements. The transition can involve reassessing classification, updating technical documentation and clinical evaluation, strengthening PMS and vigilance processes, updating the QMS and labeling, implementing UDI requirements, and addressing additional conformity assessment requirements.
EU MDR introduced revised classification rules that can affect software, reusable surgical instruments, and certain higher-risk devices. Manufacturers should reassess existing products against the MDR classification rules rather than relying solely on their previous MDD classification. A classification change can affect conformity assessment, clinical evidence, technical documentation, and Notified Body involvement.
EU MDR places greater emphasis on clinical evidence and clinical evaluation than the previous MDD framework. Manufacturers must evaluate available clinical data and demonstrate that the device meets applicable safety and performance requirements. Depending on the device, clinical evaluation can involve literature, clinical data, state-of-the-art assessment, and other supporting evidence.
A Clinical Evaluation Report (CER) documents the assessment of clinical evidence supporting a medical device’s safety, performance, and intended purpose under MDR. It can include literature evaluation, clinical data assessment, and state-of-the-art analysis. Manufacturers must ensure the CER is appropriately structured, supported by evidence, and maintained as part of the technical documentation.
EU MDR strengthens post-market surveillance and vigilance obligations for manufacturers. Depending on the device and applicable requirements, manufacturers may need PMS documentation, PMS Reports (PMSR), Periodic Safety Update Reports (PSUR), vigilance processes, and Summary of Safety and Clinical Performance (SSCP) documentation. PMS findings should also feed into risk management and clinical evaluation.
Yes. A manufacturer established outside the European Union must appoint a European Authorized Representative for applicable devices placed on the EU market. The EAR acts as the manufacturer’s regulatory representative in the EU and performs defined MDR responsibilities, including regulatory communication and supporting access to required documentation for competent authorities.
EU MDR introduces Unique Device Identification (UDI) requirements intended to improve medical device identification and traceability. Manufacturers must establish an appropriate UDI strategy and address applicable data and registration requirements. EUDAMED supports regulatory information management, so manufacturers should ensure relevant device and economic-operator information is prepared according to applicable MDR requirements.
Manufacturers must maintain a quality management system appropriate to their MDR obligations. ISO 13485 is widely used as the relevant medical device QMS standard, while the MDR establishes specific regulatory expectations. QMS processes should support areas such as design, production, risk management, clinical evaluation, regulatory documentation, and post-market surveillance.
EU MDR requires manufacturers to have access to a Person Responsible for Regulatory Compliance (PRRC) with appropriate expertise in medical device regulations. The PRRC is responsible for defined regulatory compliance activities, including ensuring conformity is appropriately checked, technical documentation and declarations of conformity are maintained, and applicable post-market surveillance obligations are addressed.