Systems and Procedure Packs under MDR

Michael M. Kania
August 1, 2019
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Medical Device Regulation

Short Input about Systems and Procedure Packs

What are the main changes in addition to the general requirements of the EU MDR in regards of Systems and Procedure Packs?

  • UDI
  • Non-Medical Devices allowed
  • Verification & Validation of the set

Its recommended to setup:

  • Clear Specification
  • Declaration of the manufacturer

Videosource: LinkedIN

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