Why MDR Compliance Matters for Distributors
If you distribute medical devices in the EU, the Medical Device Regulation (MDR 2017/745) applies to you. While MDR is often discussed in the context of manufacturers, distributors also have significant obligations—and failing to comply can lead to serious consequences.
Under MDR, distributors are no longer just middlemen. They are responsible for ensuring that the medical devices they supply are compliant and safe for use.
Key Obligations of Distributors Under MDR
Here’s a quick breakdown of your core responsibilities:
✅ Verification of Compliance – You must check that the device has a CE mark, is correctly labeled, and has valid EU declarations of conformity.
✅ Storage & Transport Conditions – Ensure devices are handled and stored as per manufacturer specifications.
✅ Incident Reporting – If you suspect a device is non-compliant or poses a risk, you must notify the manufacturer and the competent authority.
✅ Traceability & Documentation – Keep records of the devices you distribute, including supplier details and batch/lot numbers.
💡 Pro Tip: Maintaining a structured MDR compliance checklist can help streamline your processes.
Common MDR Challenges for Distributors
Many distributors struggle with:
❌ Unclear documentation from manufacturers
❌ Uncertainty about how to handle non-compliant devices
❌ Lack of internal MDR training
That’s where MRDsimplified.com comes in—we break down MDR into clear, actionable steps for distributors like you.
What’s Next?
🚀 Explore More: Check out our MDR for Distributors Guide
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