Medical device CE marking

MDCG: Software guidance


The MDCG (EU Medical Device Coordination Group) has released guidance concerning qualification and classification of software (Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR)): MDCG 2019-11.

This guidance, which primarily targets medical software manufacturers, defines the criteria for the qualification of software falling within the scope of the regulations and guides on the application of classification criteria for software. The guidance also provides information related to placing on the market. The classification criteria (classification rules) are set out in Annex VIII of the MDR and IVDR. The guidance is not legally binding.

The criteria specified in the guidance shall also apply to applications (commonly referred to as Apps), whether operating on a mobile phone, in the cloud or on other platforms.

Additionally, an ongoing guidance development document has been released. This document indicates which guidances are under construction and when they can be expected to be released.