This Technical Bulletin puts forward an EIGA position that provides guidance for the classification of medical device gases to establish a harmonised approach and to avoid different interpretations of rules and risk classes across the different EU member states.
This Technical Bulletin has been prepared by specialists from EIGA Member Companies and is their interpretation and opinion of how medical gases meeting the definition of medical devices should be classified according to specific regulations or legislation. This Technical Bulletin is not a legally binding interpretation and for this reference needs to be made to the appropriate authority.
Carbon dioxide and liquid nitrogen as well as other gases depending on their purpose in medical applications need to be defined as medical devices. A classification based on the risk is defining the required procedure for CE marking of the medical device.
With the introduction of the Medical Device Regulation some uncertainties on classification due to the new classification rule 21 for substance-based medical devices occurred.