“For each device, manufacturers shall plan, establish, document, implement, maintain and update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device…The post-market surveillance system shall be suited to actively and systematically gathering, recording and analyzing relevant data on the quality, performance, and safety of a device throughout its entire lifetime, and to drawing the necessary conclusions and to determining, implementing and monitoring any preventive and corrective actions.”

EU MDR, Article 83, Post-market Surveillance System of the Manufacturer

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The AssurX EU MDR Solution Automates the Process of MIR Submissions

European Union Medical Device Regulation (EU MDR) requires medical device manufacturers to meet significantly higher standards of quality and safety than in the previous Medical Device Directive (MDD). Post-market vigilance requirements present process challenges that require modern technology solutions.

AssurX electronic reporting solution automates the EU Manufacturer Incident Reporting (MIR), enabling timely post-market reporting of applicable medical device vigilance incidents. Post-market requirements outlined in the EU MDR carry significant process challenges and procedure updates.

The AssurX EU MDR solution aligns business logic with the most up-to-date MIR template as published by the European Commission (EC) and automates the documentation and submission in accordance with vigilance guidelines and reporting time frames.

AssurX Manufacturer Incident Reporting (MIR) submission data can be connected
to any AssurX QMS process that requires the compilation and evaluation of product
performance data.

AssurX Automated MIR Submission Solution Features

  • Rapid Implementation and Ease of Use

    The AssurX EU MDR solution is pre-configured to conform to the quality and compliance standards of the EU.  Intuitive features eliminate the need for manual lookup and reminders/ escalations keep all investigations on pace for tighter reporting deadlines.

  • Efficient, Centralized Submissions

    AssurX helps ensure information accuracy and timeliness of submissions with a range features for full transparency of each incident. Each incident becomes part of the device record, capturing detailed information including determination of reportability and justification of non-reportable events.

  • Reporting

    AssurX provides real-time tracking of reportability with a complete audit trail. Generate PDF or XML output for submission according the latest published guidelines for Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (AIMDD/MDD/IVDD).

  • Integration and UDI Data Readiness

    Under the new EU MDR, post-market events require effortless synergy to other areas within the organization. AssurX software can run standalone or integrated with the AssurX post-market surveillance quality management system for unmatched visibility into the device history. Extend the linkages of your quality system by integrating with key source systems to centralize data in a secure repository for downstream activity such as post-market investigations and reporting.

  • Professional Implementation and Support Services

    AssurX Professional Services offers a proven implementation methodology to accelerate your solution deployment and integration needs. AssurX Validation Management Services can assist in maximizing the validation efficiencies associated with future enhancements and configuration changes by re-validating your system with minimal disruption, reducing costs, and maximizing your team’s productivity.

EU MDR Readiness Check:Clinical Data, Definitions and Documentation | AssurX eBrief

EU MDR Readiness Check: Clinical Data, Definitions and Documentation

This eBrief provides a brief list of items to consider before embarking on a design change to a medical device planned for distribution to one of the European Union member states.

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AssurX EU MDR Solution Benefits

COMPLIANCE

Submit reports compliant with EU MDR within required time frames. Reminders and escalations keep users aware of deadlines, incident severity, and process next steps. Built-in audit trail and electronic signature functionality.

STREAMLINE

Minimize risk and through centralized control of the EU medical device event reporting process.

CENTRALIZE

Collect detailed, quantifiable data for trending in a centralized repository. Integrate with additional QMS processes for downstream issue management including investigations, CAPA and change management.

FLEXIBILITY

AssurX allows organizations to adapt processes in alignment with changing regulatory landscapes. Quickly incorporate EU MDR reporting changes as regulation is updated.

CONTROL

A powerful monitoring and reporting engine provide deep insight into device issues for investigations and continual product improvement.

VISIBILITY

Get real-time trending and global oversight with features that provide full visibility into the current state of incident reports.

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