EU MDR – The essentials you need to know – Classification Rules.

The changes to the classification rules in the MDR will require manufacturers to make some important changes.

In the MDR there are 22 classification rules, vs 18 in the MDD, clearly indicating the magnitude of changes.

A tool to classify your devices correctly, according to the chages brought by the  MDR, can be a great help.

Download Whitepaper on Classification Rules here

RA-Update-MDR-Annex VIII-Whitepaper-181010-Article

Questions about this topic and your device 

Randi Hauerberg
Principal Advisor/Team Lead
Regulatory Affairs & Quality Management
Connect with me on LinkedIn

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