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Sep 24, 2024·1 min read

Systems and Procedure Packs under MDR

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

M

Michael Kania

Medical Device Regulation

Systems and Procedure Packs under MDR

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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