MDCG 2019-11 Software classification in the MDR and IVDR

Last month the European Commission released MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR.


This document, which primarily targets medical software manufacturers, defines the criteria for the qualification of software falling within the scope of the new medical devices regulations and provides guidance on the application of classification criteria for software under Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR.


The guidance also provides consideration on the placing on the market and conformity assessment of medical device software as well as four annexes providing more in-depth information on specific topics. The classification criteria (classification rules) are set out in Annex VIII of the Medical Devices Regulation (EU) 2017/745 (MDR) and Annex VIII of the In vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR).


To read the whole document, tap here.