Struggling with EU MDR? Here’s How to Navigate the Challenges in 2025

The European Union’s Medical Device Regulation (EU MDR 2017/745) has introduced a new level of rigor to regulatory compliance in the medtech industry. For many companies—especially those managing legacy products—the transition has been anything but straightforward.

Since coming into full effect in 2021, MDR has replaced the previous MDD framework, requiring more detailed technical documentation, stronger clinical evidence, continuous post-market surveillance (PMS), and a proactive approach to risk management.

And while the intention is to improve patient safety and product transparency, the practical impact has been intense: increased workload, stricter audits, and more pressure across quality, regulatory, and R&D teams.

So how can organizations adapt without getting buried in spreadsheets, version conflicts, or manual change control?

Let’s break it down.

What Makes EU MDR So Challenging?

While EU MDR affects all medtech companies, those with legacy products—certified under MDD and still on the market—often face the steepest climb. In many cases, documentation has not been updated in years, clinical evidence is outdated, and risk processes were built for a different regulatory era, also documents referencing outdated standards.

Here are three common gaps we’re seeing:

1. Clinical Data Deficiencies

Legacy products often lack the level of clinical data now required under MDR. This means companies must invest time and resources into retrospective analysis, additional clinical evaluation reports (CERs), or real-world evidence collection.

2. Incomplete Technical Documentation

Under MDR, the expectation for technical documentation goes far beyond previous norms. Many files must be restructured, updated, and aligned with Annex II and III requirements. A simple product update can trigger a full documentation overhaul.

3. Disconnected Risk and Quality Processes

MDR requires a seamless connection between design, risk management (aligned with ISO 14971 Edition 2019), PMS, vigilance, and CAPA. Many companies still manage these processes in silos, making it challenging to prove traceability during an audit.

How a Modern QMS Can Help (and Why Many Teams Are Upgrading)

Rather than trying to patch things together manually, many companies are turning to electronic Quality Management Systems (eQMS) to streamline MDR compliance.

At Orcanos, we’ve seen firsthand how a connected, cloud-based QMS makes a difference:

• Document Control becomes traceable, version-controlled, and audit-ready.
  
  
• Risk Management links directly to design controls and is automatically updated.
  
  
• Change Control Workflows ensure nothing slips through the cracks.
  
  
• Post-Market Surveillance & CAPA are integrated into daily operations.
  
  
• Dashboards and Reporting Tools make it easy to prevent  issues before regulators correct the organization.
  
  

A good QMS doesn’t just help you pass audits—it makes ongoing compliance more sustainable across the product lifecycle.

Case in Point: ZygoFix and Multi-Region Compliance

One example that stands out is ZygoFix, a medical device company that used Orcanos to manage both EU MDR and FDA 510(k) submissions. Their team needed a partner that understood the intricacies of both regulatory systems and could offer a flexible platform for mapping documentation, managing risk, and handling change control.

“We were impressed by Orcanos’ attention and expertise in the medical device industry… Having obtained both CE certification and FDA clearance with Orcanos, we are confident we made the right choice.”
— ZygoFix Team

With centralized documentation, traceable risk files, and compliant workflows, ZygoFix was able to meet MDR and FDA expectations without duplicating effort or reinventing internal processes.

Getting Started with EU MDR Resources

Whether you’re new to MDR or already navigating a recertification project, it’s important to have the right tools—and the right knowledge.

That’s why we built the Orcanos MDR Resource Hub, which includes:

• 📘 A free EU MDR training course series (great for onboarding teams)
  
  
• 🧩 Checklists and templates aligned with MDR Annexes
  
  
• 🧠 Guidance on integrating risk, clinical, and design data
  
  

You can access it here:
👉 Explore the Orcanos MDR Resource Hub

Final Thoughts: EU MDR Compliance Is Ongoing, Not One-and-Done

The regulatory landscape will continue to evolve, and EU MDR is only the beginning. As authorities increase their scrutiny and harmonization with global frameworks continues, the companies that will thrive are the ones that treat compliance as a strategic capability, not just a checkbox.

Whether you’re dealing with aging product lines or building something entirely new, tools like Orcanos can help you stay agile and compliant—without burning out your team.

Need help assessing your readiness or modernizing your QMS?
Reach out to us or explore our free resources to start moving forward with more clarity and less stress.

👉 Start a Free Demo
👉 Visit the MDR Academy

Disclaimer: Orcanos provides customizable solutions tailored to your specific product and regulatory needs. There is no one-size-fits-all approach.

‍