EU MDR Compliance Services
Comprehensive support to achieve and maintain compliance with the European Union Medical Device Regulation (MDR) 2017/745.
Understanding EU MDR 2017/745
The European Union Medical Device Regulation (MDR) 2017/745 replaced the previous Medical Device Directive (MDD) in May 2021, introducing more stringent requirements for medical devices marketed in the EU. MDR aims to enhance patient safety, improve transparency, and strengthen the regulatory oversight of medical devices.
Our MDR compliance services guide manufacturers through the complex requirements of the regulation, ensuring a smooth transition from MDD and ongoing compliance with all MDR obligations.
Key Changes Under EU MDR
- Enhanced clinical evaluation requirements
- Stricter post-market surveillance obligations
- Expanded product classification rules
- New unique device identification (UDI) requirements
- Increased scrutiny of notified body activities
Our EU MDR Compliance Solutions
Comprehensive support for all aspects of MDR compliance
MDR Gap Analysis
Comprehensive assessment of your current compliance status against MDR requirements to identify gaps and develop a remediation plan.
Technical Documentation
Preparation and review of MDR-compliant technical documentation, including the Device Master Record and EU Declaration of Conformity.
Clinical Evaluation
Support for MDR-compliant clinical evaluations, including literature reviews, clinical data analysis, and preparation of Clinical Evaluation Reports (CERs).
Post-Market Surveillance
Development and implementation of MDR-compliant post-market surveillance systems and preparation of Periodic Safety Update Reports (PSURs).
UDI Implementation
Guidance on Unique Device Identification (UDI) requirements, including UDI assignment, labeling, and data submission to EUDAMED.
Notified Body Coordination
Support in selecting notified bodies and coordinating the conformity assessment process, including preparation for audits and response to findings.
MDR Compliance Implementation Roadmap
A structured approach to achieving MDR compliance
Assessment & Planning
Conduct MDR gap analysis, determine device classification, and develop a comprehensive implementation plan with timelines and resource requirements.
Documentation Development
Prepare and revise technical documentation, clinical evaluation reports, and quality management system documentation to meet MDR requirements.
Documentation Development
Documentation Development
Prepare and revise technical documentation, clinical evaluation reports, and quality management system documentation to meet MDR requirements.
System Implementation
Implement required systems for post-market surveillance, UDI, vigilance reporting, and EUDAMED data submission.
Notified Body Engagement
Select appropriate notified body, submit technical documentation, and prepare for conformity assessment audits.
Notified Body Engagement
Notified Body Engagement
Select appropriate notified body, submit technical documentation, and prepare for conformity assessment audits.
Certification & Compliance
Address audit findings, obtain MDR certification, implement ongoing compliance activities, and maintain documentation updates.
Why Choose Our EU MDR Compliance Services
Expert guidance through complex MDR requirements
MDR Expertise
Deep understanding of MDR requirements and practical experience helping manufacturers achieve and maintain compliance.
Notified Body Relationships
Established relationships with leading notified bodies to streamline the conformity assessment process.
Practical Implementation
Pragmatic approach to MDR compliance that balances regulatory requirements with business needs and resource constraints.
Ongoing Support
Continuous support beyond initial certification, including updates to changing requirements and ongoing compliance activities.
Achieve EU MDR Compliance with Confidence
Our MDR experts will guide you through every aspect of compliance, ensuring your devices can continue to access the EU market while meeting all regulatory requirements.
Get MDR Compliance Consultation