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Product Classification

Medical Device Classification: EU

Rule-by-rule classification under MDR 2017/745 with a written rationale memo.

European UnionMedical DevicesFixed scope
Deliverables

What you receive.

  • 01Rule-by-rule classification analysis
  • 02Written classification rationale
  • 03Applicable standards list
  • 04Route-to-market confirmation
How it works

From call to delivery.

  1. 01Book a discovery call and share your product details
  2. 02We confirm scope, timeline and price
  3. 03You upload existing documentation
  4. 04We deliver the regulatory output and next steps
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