IVDR Device Classification

Devices are classified based on intended purpose of the devices and their inherent risks. There are 4 classes A, B, C and D.Below figure shows the MDR 2017/746 risk based classification.

All implementing rules, classification rules, and indents are to be taken into account

IVDD devices are list based and IVDR 2017/746 introduces rule based classification(7 rules) .All IVD manufacturer needs to analyse their device class.

IVDD devices are list based and IVDR 2017/746 introduces rule based classification .All IVD manufacturer needs to analyse their device class

Click below link to know more about MDR Device Classification:https://meddev-info.blogspot.com/2021/01/mdr_5.html

Source:

REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

MDCG 2020-16- Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746