EU MDR (European Medical Device Regulation)

How RQMIS Helps

We don’t just help you comply—we help you build a sustainable EU MDR strategy that supports both approval and long-term success.

EU MDR Gap Assessment

We quickly identify where you stand—and what needs to change.

• Technical documentation review (Annex II & III)
• Clinical evaluation gaps
• PMS and vigilance system assessment
• QMS alignment with MDR expectations

Technical Documentation & CER Development

We build documentation that holds up under Notified Body scrutiny.

• Clinical Evaluation Reports (CER)
• Risk management files (ISO 14971 aligned)
• General Safety & Performance Requirements (GSPR)
• Labeling and IFU alignment

Post-Market Surveillance (PMS) System Implementation

This is where most companies struggle—and where MDR is most demanding.

Under MDR, manufacturers must implement a proactive, continuous PMS system that:

• Systematically collects and analyzes real-world data
• Updates risk management and clinical evaluation
• Drives corrective and preventive actions
• Maintains compliance throughout the device lifecycle

We help you build:

• PMS Plans (Article 84)
• PMS Reports (Article 85)
• Periodic Safety Update Reports (PSUR – Article 86)
• Trend reporting and signal detection processes

Clinical Strategy & PMCF

EU MDR requires stronger clinical justification than ever before.

We support:

• Clinical evaluation strategy
• Literature and data analysis
• Post-Market Clinical Follow-up (PMCF) planning and execution
• Integration of real-world evidence into regulatory documentation

Notified Body Strategy & Submission Support

Approval depends as much on strategy as documentation.

We help you:

• Select and engage the right Notified Body
• Prepare and submit technical files
• Respond to questions and deficiencies
• Navigate audits and reviews

A Lifecycle Approach to Compliance

EU MDR is not a one-time submission—it’s a continuous system.

Manufacturers are required to:

• Actively collect post-market data
• Analyze trends and identify risks
• Update technical documentation continuously
• Implement corrective and preventive actions as needed

This is where most organizations fall behind—and where RQMIS creates long-term value.

The Outcome

With RQMIS, you can:

• Achieve EU MDR compliance faster
• Reduce risk of Notified Body rejection or delays
• Strengthen clinical and post-market evidence
• Maintain continuous compliance after approval
• Protect and expand your access to the European market

Why RQMIS

• Deep expertise in EU MDR and global regulatory frameworks
• Integrated regulatory, clinical, and quality capabilities
• Proven ability to close gaps and accelerate approvals
• Practical, execution-focused support—not just advisory

We don’t just help you meet MDR—we help you operate within it efficiently.

Don’t Let EU MDR Block Your Market Access

The longer you wait to address MDR requirements, the harder—and more expensive—it becomes.