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Product compliance

EU MDR

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Our EU MDR technology

The European Union Medical Device Regulation (EU MDR) restricts the use of hazardous substances in medical devices placed on the EU market and establishes reporting requirements for devices containing any restricted substances over a certain threshold. The regulation’s complex classification system determines how compliance is achieved, which requires companies to have a thorough understanding of the regulation and how their devices are classified. This quickly becomes overwhelming for many companies and exposes them to uncertainty and risk, which can lead to fines, litigation, and product recalls.

Source Intelligence’s EU MDR platform helps reduce the uncertainty around EU MDR compliance and streamline the compliance process, including understanding how to classify your medical device(s), gathering clinical evidence, and collecting data. We help facilitate supplier engagement, data analysis, and documentation generation based on the level of support your business requires. Whether you want to leverage our software to self-manage your EU MDR compliance efforts or utilize our expert-managed services to do the heavy lifting, we’ll provide you with the peace of mind that your medical devices are EU MDR compliant.

Key features of our EU MDR software:

  • Multi-tiered BOM management
  • Flexible modular platform
  • Integrations to all major PLM & ERP platforms
View program guide
Source Intelligence EU MDR Solutions

Our EU MDR program empowers you to:

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Reduce internal resource burdens

Streamline due diligence efforts, such as supplier engagement, data collection, and report generation, and refocus internal resources on managing other parts of your business.

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Minimize business risk

Easily provide documentation on demand. Your compliance data is housed in a centralized location, so you can efficiently generate reports and declarations to fulfill customer requests.

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Gain supply chain visibility

Quickly identify issues with a complete view of your compliance and product data. Our configurable dashboards and BOM rollups display compliance verdicts for every part and component.

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Increase risk foresight

Our regulatory experts guide our solution development, ensuring you have the right tools to anticipate changes to your compliance obligations and setting you up for compliance success.

Common questions about our EU MDR program

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Can I purchase software to manage my EU MDR compliance program internally?
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What platforms does Source Intelligence’s EU MDR technology integrate with?
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How is Source Intelligence different from other supply chain compliance software providers?
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Topics to explore further

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EU MDR Compliance: A Complete Guide

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Product Compliance for Medical Device Manufacturing

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6 Best Practices for Product Compliance Management

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Solutions to fit your needs

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Product compliance
Identify risks to ensure every supplier, part, and product meets core compliance obligations.
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Responsible sourcing
Uncover exposure to suppliers engaged in conflict mineral sourcing, deforestation, human rights violations, and other areas of concern.
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Sustainability
Comply with the increasing number of sustainability policies and escalating consumer demands, including Extended Producer Responsibility (EPR) legislation.
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Parts obsolescence
Avoid unnecessary production delays by receiving early warning of parts at risk of obsolescence with plenty of time to identify replacements.
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Streamline compliance with our EU MDR solution

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Events and news

Webinars, blogs, e-books, and other tools to stay on top of the fast-changing compliance landscape
Webinar: Countdown to EUDR Compliance
Learn how to prepare for the European Union Deforestation Regulation (EUDR) due diligence requirements and how to comply.
E-Book: PFAS Regulatory Compliance Guide
Get our complete guide to mitigating risk and ensuring PFAS compliance in your supply chain.

See for yourself

Our process is simple:
1
Complete the form and tell us a bit about your company’s compliance challenges
2
Within 24 hours, a consultant will reach out to schedule a 20-minute phone call to explore your goals and needs
3
Based on the call, we’ll build out a custom demo with the Source Intelligence programs and services most relevant to you
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